Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

NCT03878524 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY00015588NCI-2020-02743
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This phase Ib trial determines if samples from a patient's cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.

Conditions

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Feasibility of implementing an individualized treatment strategy (number of participants to receive first dose)

  Measured as the number of participants to receive the first dose of Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART)-PRIME therapy (Therapy #1) within 3 months from the date of Clinical Tumor Board providing a recommended drug combination.

  From date of tumor board recommendation to first dose of SMMART-PRIME Therapy #1 (up to 3 months)

Secondary Outcomes (4)

• Incidence of grade 3+ toxicities attributable to assigned study drug(s)

  30 days post completion of each SMMART-PRIME Therapy (up to 6 months)

• Time to treatment discontinuation

  Completion of SMMART-PRIME Therapy #1 (up to 6 months)

• Overall survival (OS)

  Death from any cause (up to 60 months after the last dose of SMMART-PRIME Therapy #1)

• Time to decline (TTD)

  Completion of SMMART-PRIME Therapy #1 (up to 6 months)

Study Arms (1)

Treatment (biospecimen collection, 2 drug combination)

EXPERIMENTAL

TUMOR BIOPSY: Patients undergo collection of tissue samples. Clinical analytics are performed on the samples and analyzed by a clinical tumor board to recommend a treatment option based on those analytics. SMMART-PRIME TREATMENT: Patients receive a combination of 2 drugs (Drug A and Drug B, selected from interventions below). Doses will be escalated within individual patients over time. As described in detail below, escalation will occur monthly and is anticipated to occur as follows: first month - 100% FDA approved dose Drug A + 25% FDA approved dose Drug B; second month -- 100% dose Drug A + 50% dose Drug B; third month -- 100% dose Drug A + 100% dose Drug B. All dose-escalations will be reviewed and approved by an independent consultant outside of Oregon Health \& Science University (OHSU). Treatment will continue for up to the end of 6 treatment cycles (cycle length is between 21-28 days) in the absence of disease progression or unacceptable toxicity.

Drug: Abemaciclib; Drug: Abiraterone; Drug: Afatinib; Biological: Bevacizumab; Drug: Bicalutamide; Procedure: Biospecimen Collection; Drug: Bortezomib; Drug: Cabazitaxel; Drug: Cabozantinib; Drug: Capecitabine; Drug: Carboplatin; Drug: Celecoxib; Drug: Cobimetinib; Drug: Copanlisib; Drug: Dabrafenib; Drug: Dacomitinib; Drug: Darolutamide; Drug: Dasatinib; Drug: Doxorubicin; Biological: Durvalumab; Drug: Enasidenib; Drug: Entrectinib; Drug: Enzalutamide; Drug: Erlotinib; Drug: Everolimus; Drug: Fluorouracil; Drug: Idelalisib; Drug: Imatinib; Biological: Ipilimumab; Drug: Lenvatinib; Drug: Leucovorin; Drug: Lorlatinib; Drug: Losartan; Drug: Nab-paclitaxel; Drug: Neratinib; Biological: Nivolumab; Drug: Olaparib; Drug: Oxaliplatin; Drug: Palbociclib; Drug: Panobinostat; Biological: Pembrolizumab; Biological: Pertuzumab; Drug: Ponatinib; Other: Quality-of-Life Assessment; Drug: Regorafenib; Drug: Ruxolitinib; Drug: Sirolimus; Drug: Sorafenib; Drug: Sunitinib; Drug: Trametinib; Biological: Trastuzumab Emtansine; Drug: Tretinoin; Drug: Vemurafenib; Drug: Venetoclax; Drug: Vismodegib; Drug: Vorinostat

Interventions

Abemaciclib DRUG

Given PO

Also known as: LY-2835219, LY2835219, Verzenio

Treatment (biospecimen collection, 2 drug combination)

Abiraterone DRUG

Given PO

Also known as: CB 7598

Treatment (biospecimen collection, 2 drug combination)

Afatinib DRUG

Given PO

Also known as: BIBW 2992, BIBW2992

Treatment (biospecimen collection, 2 drug combination)

Bevacizumab BIOLOGICAL

Given IV

Also known as: ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev, Anti-VEGF Monoclonal Antibody SIBP04, SIBP 04, SIBP-04, SIBP04

Treatment (biospecimen collection, 2 drug combination)

Bicalutamide DRUG

Given PO

Also known as: Casodex, Cosudex, ICI 176,334, ICI 176334

Treatment (biospecimen collection, 2 drug combination)

Biospecimen Collection PROCEDURE

Undergo collection of biospecimens (including tissue, blood, or previously collected archival specimens)

Also known as: Biological Sample Collection, Specimen Collection

Treatment (biospecimen collection, 2 drug combination)

Bortezomib DRUG

Given IV

Also known as: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341, PS341, Velcade

Treatment (biospecimen collection, 2 drug combination)

Cabazitaxel DRUG

Given IV

Also known as: Jevtana, RPR-116258A, Taxoid XRP6258, XRP-6258

Treatment (biospecimen collection, 2 drug combination)

Cabozantinib DRUG

Given PO

Treatment (biospecimen collection, 2 drug combination)

Capecitabine DRUG

Given PO

Also known as: Ro 09-1978/000, Xeloda

Treatment (biospecimen collection, 2 drug combination)

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (biospecimen collection, 2 drug combination)

Celecoxib DRUG

Given PO

Also known as: Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177

Treatment (biospecimen collection, 2 drug combination)

Cobimetinib DRUG

Given PO

Also known as: Cotellic, GDC-0973, MEK Inhibitor GDC-0973, XL518, 934660-93-2

Treatment (biospecimen collection, 2 drug combination)

Copanlisib DRUG

Given IV

Also known as: BAY 80-6946, PI3K Inhibitor BAY 80-6946

Treatment (biospecimen collection, 2 drug combination)

Dabrafenib DRUG

Given PO

Also known as: BRAF Inhibitor GSK2118436, GSK-2118436, GSK-2118436A, GSK2118436

Treatment (biospecimen collection, 2 drug combination)

Dacomitinib DRUG

Given PO

Also known as: EGFR Inhibitor PF-00299804, PF-00299804, PF-00299804-03, PF-299804, Vizimpro

Treatment (biospecimen collection, 2 drug combination)

Darolutamide DRUG

Given PO

Also known as: Antiandrogen ODM-201, BAY 1841788, BAY-1841788, BAY1841788, Nubeqa, ODM 201, ODM-201, 1297538-32-9

Treatment (biospecimen collection, 2 drug combination)

Dasatinib DRUG

Given PO

Also known as: BMS-354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel

Treatment (biospecimen collection, 2 drug combination)

Doxorubicin DRUG

Given IV

Also known as: Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin

Treatment (biospecimen collection, 2 drug combination)

Durvalumab BIOLOGICAL

Given IV

Also known as: Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736, 1428935-60-7

Treatment (biospecimen collection, 2 drug combination)

Enasidenib DRUG

Given PO

Also known as: AG-221, CC-90007 Free Base

Treatment (biospecimen collection, 2 drug combination)

Entrectinib DRUG

Given PO

Also known as: Rozlytrek, RXDX 101, RXDX-101, RXDX101

Treatment (biospecimen collection, 2 drug combination)

Enzalutamide DRUG

Given PO

Also known as: ASP9785, MDV3100, Xtandi

Treatment (biospecimen collection, 2 drug combination)

Erlotinib DRUG

Given PO

Treatment (biospecimen collection, 2 drug combination)

Everolimus DRUG

Given PO

Also known as: 42-O-(2-Hydroxy)ethyl Rapamycin, Afinitor, Certican, RAD 001, RAD001, Votubia, Zortress

Treatment (biospecimen collection, 2 drug combination)

Fluorouracil DRUG

Given IV

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Treatment (biospecimen collection, 2 drug combination)

Idelalisib DRUG

Given PO

Also known as: CAL-101, GS 1101, GS-1101, Phosphoinositide-3 Kinase Delta Inhibitor CAL-101, Zydelig

Treatment (biospecimen collection, 2 drug combination)

Imatinib DRUG

Given PO

Treatment (biospecimen collection, 2 drug combination)

Ipilimumab BIOLOGICAL

Given IV

Also known as: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy

Treatment (biospecimen collection, 2 drug combination)

Lenvatinib DRUG

Given PO

Also known as: E7080, ER-203492-00, Multi-Kinase Inhibitor E7080

Treatment (biospecimen collection, 2 drug combination)

Leucovorin DRUG

Given IV

Also known as: Folinic acid

Treatment (biospecimen collection, 2 drug combination)

Lorlatinib DRUG

Given PO

Also known as: 2H-4,8-Methenopyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile, 7-amino-12-fluoro-10,15,16,17-tetrahydro-2,10,16-trimethyl-15-oxo-, (10R)-, Lorbrena, PF-06463922

Treatment (biospecimen collection, 2 drug combination)

Losartan DRUG

Given PO

Treatment (biospecimen collection, 2 drug combination)

Nab-paclitaxel DRUG

Given IV

Also known as: ABI 007, ABI-007, Abraxane, Albumin-bound Paclitaxel, Albumin-Stabilized Nanoparticle Paclitaxel, Nanoparticle Albumin-bound Paclitaxel, Nanoparticle Paclitaxel, Paclitaxel Albumin, paclitaxel albumin-stabilized nanoparticle formulation, Protein-bound Paclitaxel

Treatment (biospecimen collection, 2 drug combination)

Neratinib DRUG

Given PO

Also known as: (2E)-N-(4-((3-chloro-4-((pyridin-2-yl)methoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)-4-(dimethylamino)but-2-enamide, HKI 272, HKI-272, PB 272, PB-272

Treatment (biospecimen collection, 2 drug combination)

Nivolumab BIOLOGICAL

Given IV

Also known as: BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo

Treatment (biospecimen collection, 2 drug combination)

Olaparib DRUG

Given PO

Also known as: AZD 2281, AZD-2281, AZD2281, KU-0059436, Lynparza, PARP Inhibitor AZD2281

Treatment (biospecimen collection, 2 drug combination)

Oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669

Treatment (biospecimen collection, 2 drug combination)

Palbociclib DRUG

Given PO

Also known as: 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one, Ibrance, PD 0332991, PD 332991, PD 991, PD-0332991

Treatment (biospecimen collection, 2 drug combination)

Panobinostat DRUG

Given PO

Also known as: Faridak, LBH589

Treatment (biospecimen collection, 2 drug combination)

Pembrolizumab BIOLOGICAL

Given IV

Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

Treatment (biospecimen collection, 2 drug combination)

Pertuzumab BIOLOGICAL

Given IV

Also known as: 2C4, 2C4 Antibody, HS627, MoAb 2C4, Monoclonal Antibody 2C4, Omnitarg, Perjeta, Pertuzumab Biosimilar HS627, rhuMAb2C4, RO4368451, HLX11

Treatment (biospecimen collection, 2 drug combination)

Ponatinib DRUG

Given PO

Also known as: AP-24534, AP24534

Treatment (biospecimen collection, 2 drug combination)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (biospecimen collection, 2 drug combination)

Regorafenib DRUG

Given PO

Also known as: BAY 73-4506, REGORAFENIB ANHYDROUS, Stivarga

Treatment (biospecimen collection, 2 drug combination)

Ruxolitinib DRUG

Given PO

Also known as: INCB-18424, INCB18424, Jakafi, Oral JAK Inhibitor INCB18424

Treatment (biospecimen collection, 2 drug combination)

Sirolimus DRUG

Given PO

Also known as: AY 22989, RAPA, Rapamune, Rapamycin, SILA 9268A, WY-090217

Treatment (biospecimen collection, 2 drug combination)

Sorafenib DRUG

Given PO

Also known as: BA4 43 9006, BAY 43-9006, Bay-439006

Treatment (biospecimen collection, 2 drug combination)

Sunitinib DRUG

Given PO

Treatment (biospecimen collection, 2 drug combination)

Trametinib DRUG

Given PO

Also known as: GSK1120212, JTP-74057, MEK Inhibitor GSK1120212

Treatment (biospecimen collection, 2 drug combination)

Trastuzumab Emtansine BIOLOGICAL

Given IV

Also known as: Ado Trastuzumab Emtansine, ADO-Trastuzumab Emtansine, Kadcyla, PRO132365, RO5304020, T-DM1, Trastuzumab-DM1, Trastuzumab-MCC-DM1, Trastuzumab-MCC-DM1 Antibody-Drug Conjugate, Trastuzumab-MCC-DM1 Immunoconjugate

Treatment (biospecimen collection, 2 drug combination)

Tretinoin DRUG

Given PO

Also known as: 2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-, Aberel, Airol, Aknoten, all trans-Retinoic acid, All-trans Retinoic Acid, All-trans Vitamin A Acid, all-trans-Retinoic acid, all-trans-Vitamin A acid, ATRA, Avita, beta-Retinoic Acid, Cordes Vas, Dermairol, Epi-Aberel, Eudyna, Renova, Retin-A, Retin-A MICRO, Retin-A-Micro, Retinoic Acid, Retisol-A, Ro 5488, Stieva-A, Stieva-A Forte, Trans Retinoic Acid, Trans Vitamin A Acid, trans-Retinoic Acid, Tretinoinum, Vesanoid, Vitamin A Acid, Vitamin A acid, all-trans-, Vitinoin

Treatment (biospecimen collection, 2 drug combination)

Vemurafenib DRUG

Given PO

Also known as: BRAF (V600E) kinase inhibitor RO5185426, BRAF(V600E) Kinase Inhibitor RO5185426, PLX-4032, PLX4032, RG 7204, RG7204, RO 5185426, Zelboraf

Treatment (biospecimen collection, 2 drug combination)

Venetoclax DRUG

Given PO

Also known as: ABT-0199, ABT-199, ABT199, GDC-0199, RG7601, Venclexta, Venclyxto

Treatment (biospecimen collection, 2 drug combination)

Vismodegib DRUG

Given PO

Also known as: Erivedge, GDC-0449, Hedgehog Antagonist GDC-0449

Treatment (biospecimen collection, 2 drug combination)

Vorinostat DRUG

Given PO

Also known as: L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid, Suberoylanilide Hydroxamic Acid, Zolinza

Treatment (biospecimen collection, 2 drug combination)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document
• Participants \>= 21 years old at time of informed consent. Both men and women and members of all races and ethnic groups will be included
• Participants, both men and women, must agree to use an adequate method of contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study
• Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to start of study drug administration
• Patients must have a histologically or cytologically-confirmed metastatic solid tumor or hematological malignancy that has progressed as follows:
• Patients with a solid tumor must have metastatic disease and have progressed on at least 1 line of established therapy that is known to provide clinical benefit, or for whom no standard curative therapy exists. Participants with newly diagnosed, unresectable, locally-advanced or metastatic pancreatic adenocarcinoma and are beginning first-line treatment with a course of chemotherapy are eligible OR
• Participants must have a hematological malignancy that is advanced, relapsed, or refractory to at least 1 line of established therapy that is known to provide clinical for the treatment of their disease. Hematological disease included in this study are as follows:
• Acute myelogenous leukemia (AML), or
• Myelodysplastic syndrome (MDS), or
• MDS/myeloproliferative neoplasms (MDS/MPN), or
• Primary myelofibrosis (PMF)
• Acute lymphoblastic leukemia (ALL)
• Chronic myelogenous leukemia (CML)
• Non-Hodgkin lymphoma (NHL) or Hodgkin's disease (HD)
• Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

You may not qualify if:

• Participants with metastases to the central nervous system that are considered uncontrolled and/or were diagnosed within the past 4 weeks of screening for this study
• Participants cannot have an active malignancy of another cancer. Those with a history of prior malignancy will be considered on a case-by-case basis. Guiding examples for those who can be enrolled include: individuals who have been disease free for \> 5 years; individuals who are considered to have a high likelihood of being cured (e.g., prior history of stage 1 rectal cancer and currently otherwise disease free); adequately treated localized non-melanomatous skin cancer
• Participants cannot be on other forms of anti-cancer therapy at the same time, except as described within this protocol. There must be at least a washout period that accounts for 5 half-lives (or \>= 21 days, whichever is longer) of last therapy
• Participants with prostate cancer (PCa) will continue treatment with androgen deprivation therapy, either by prior castration or treatment with luteinizing hormone-releasing hormone (LHRH) antagonists or agonists, as is standard practice
• Participants with breast cancer (BCa) who are HER2 positive may continue to receive anti-HER2 therapy per standard practice guidelines, while participants who are hormone receptor positive may continue to receive hormone therapy per standard practice guidelines
• Participants with a hematological malignancy may continue to receive hydroxyurea or other hypomethylating agent for two cycles of SMMART-PRIME therapy, as described in this protocol
• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure
• Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the control of GVHD
• Participants with uncontrolled infection will not be enrolled until infection is treated
• Participant is seropositive with human immunodeficiency virus (HIV) or has active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
• HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
• For patients with evidence of chronic HBV infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• Individuals with a history of HCV infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Participants with medical conditions, inclusive of psychiatric, that in the opinion of the investigators would jeopardize the patient or the study will be excluded
• Participants that are pregnant or breast feeding

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated Phase; Anemia; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Blast Crisis; Leukemia, Myeloid, Chronic-Phase; Breast Neoplasms; Neoplasm Metastasis; Thrombocytosis; Myeloproliferative Disorders; Primary Myelofibrosis; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hematologic Neoplasms; Hodgkin Disease; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Lymphoma, Non-Hodgkin; Multiple Myeloma; Leukemia, Myelomonocytic, Chronic; Pancreatic Neoplasms; Prostatic Neoplasms

Interventions

abemaciclib; abiraterone; Afatinib; Bevacizumab; Immunoglobulin G; Disulfides; bicalutamide; Specimen Handling; Bortezomib; cabazitaxel; XRP6258; cabozantinib; Capecitabine; Carboplatin; Celecoxib; cobimetinib; copanlisib; dabrafenib; dacomitinib; darolutamide; Dasatinib; Doxorubicin; durvalumab; enasidenib; entrectinib; enzalutamide; Erlotinib Hydrochloride; Everolimus; Fluorouracil; dehydroftorafur; idelalisib; Imatinib Mesylate; Ipilimumab; CTLA-4 Antigen; lenvatinib; Leucovorin; lorlatinib; Losartan; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Taxes; neratinib; Nivolumab; olaparib; Oxaliplatin; palbociclib; Panobinostat; pembrolizumab; pertuzumab; 2C4 antibody; ponatinib; regorafenib; ruxolitinib; Sirolimus; Sorafenib; Sunitinib; trametinib; Ado-Trastuzumab Emtansine; Tretinoin; Vemurafenib; venetoclax; HhAntag691; Vorinostat

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Blood Platelet Disorders; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Lymphoma; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Isotypes; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Pyrazoles; Azoles; Thiazoles; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Macrolides; Lactones; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Piperazines; Immune Checkpoint Proteins; Costimulatory and Inhibitory T-Cell Receptors; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Coenzymes; Enzymes and Coenzymes; Biphenyl Compounds; Imidazoles; Tetrazoles; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Albumins; Economics; Health Care Economics and Organizations; Hydroxamic Acids; Hydroxylamines; Amines; Hydroxy Acids; Indoles; Phenylurea Compounds; Urea; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Pyrroles; Maytansine; Lactams, Macrocyclic; Macrocyclic Compounds; Trastuzumab; Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Pigments, Biological; Anilides; Aniline Compounds

Study Officials

• Lara Davis, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 18, 2019
• Study Start: April 1, 2020
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

US (1)