9-ING-41 in Patients with Advanced Cancers

NCT03678883 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 1801
• Study Type: interventional
• Target: 350
• Locations: 7 countries
• Sites: 66

Brief Summary

GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.

Conditions

Cancer; Pancreatic Cancer; Sarcoma; Renal Cancer; Refractory Cancer; Refractory Neoplasm; Refractory Non-Hodgkin Lymphoma; Pancreatic Adenocarcinoma; Resistant Cancer; Neoplasm Metastasis; Neoplasm of Bone; Neoplasm, Breast; Neoplasm of Lung; Neoplasms,Colorectal; Neoplasms Pancreatic; Malignant Glioma; Malignancies; Malignancies Multiple; Bone Metastases; Bone Neoplasm; Bone Cancer; Pancreas Cancer; Pancreatic Neoplasms; Breast Neoplasms; Acute T Cell Leukemia Lymphoma

Keywords

Refractory cancers; 9-ING-41; Glycogen Synthase Kinase; GSK-3β; NF-κβ; Apoptosis; Chemoresistance; DNA damage response DDR; Ataxia telangiectasia mutated and Rad3 related ATR; Checkpoint kinase 1 CHK1; Checkpoint Inhibitor; LAG-3; ATLL

Outcome Measures

Primary Outcomes (2)

• Parts 1/2: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

  The standard assessments used to assign a score to any affected organ system as per the NCI CTCAE 4.03 will be conduced at each protocol-specified timepoint.

  3 months to 3 years

• Part 3 Arm B

  To determine the 1-year survival rate of patients treated on the 9-ING-41 schedule chosen from the run-in stage of the study compared to the control arm

  3 months to 3 years

Study Arms (8)

9-ING-41

EXPERIMENTAL

Drug: 9-ING-41

Drug: 9-ING-41

9-ING-41 plus Gemcitabine

EXPERIMENTAL

Drugs: Gemcitabine - 21 day cycle. 9-ING-41

Drug: 9-ING-41; Drug: Gemcitabine - 21 day cycle

9-ING-41 plus Doxorubicin

EXPERIMENTAL

Drugs: Doxorubicin. 9-ING-41

Drug: 9-ING-41; Drug: Doxorubicin.

9-ING-41 plus Lomustine

EXPERIMENTAL

Drugs: Lomustine. 9-ING-41.

Drug: 9-ING-41; Drug: Lomustine

9-ING-41 plus Carboplatin

EXPERIMENTAL

Drugs: Carboplatin. 9-ING-41.

Drug: 9-ING-41; Drug: Carboplatin.

9-ING-41 plus nab paclitaxel Gemcitabine

EXPERIMENTAL

Drugs: Nab-paclitaxel. Gemcitabine - 28 day cycle. 9-ING-41.

Drug: 9-ING-41; Drug: Nab paclitaxel.; Drug: Gemcitabine - 28 day cycle

9-ING-41 plus Paclitaxel/Carboplatin

EXPERIMENTAL

Drugs: Paclitaxel. Carboplatin. 9-ING-41.

Drug: 9-ING-41; Drug: Carboplatin.; Drug: Paclitaxel.

9-ING-41 plus Irinotecan

EXPERIMENTAL

Drugs: Irinotecan. 9-ING-41.

Drug: 9-ING-41; Drug: Irinotecan

Interventions

9-ING-41 DRUG

Starting dose of-9-ING-41 will be administered on Day 1 and 4 each week of a 21-day cycle. 9-ING-41 will be administered intravenously over 60 minutes.

9-ING-41; 9-ING-41 plus Carboplatin; 9-ING-41 plus Doxorubicin; 9-ING-41 plus Gemcitabine; 9-ING-41 plus Irinotecan; 9-ING-41 plus Lomustine; 9-ING-41 plus Paclitaxel/Carboplatin; 9-ING-41 plus nab paclitaxel Gemcitabine

Gemcitabine - 21 day cycle DRUG

Gemcitabine 1250 mg/m2 as a 30-minute intravenous infusion on Days 1 and 8 of a 21-day cycle

Also known as: Gemzar

9-ING-41 plus Gemcitabine

Doxorubicin. DRUG

Doxorubicin 75 mg/m2, intravenous bolus on Day 1 of a 21-day cycle up to a maximum lifetime dose of 550 mg/m2.

Also known as: Doxil, Adriamycin

9-ING-41 plus Doxorubicin

Lomustine DRUG

Lomustine 30 mg/m² orally as a single dose, weekly for twelve weeks.

Also known as: CCNU, Gleostine

9-ING-41 plus Lomustine

Carboplatin. DRUG

Carboplatin AUC 6 IV over 1 hour on Day 1 of a 21-day cycle.

Also known as: Paraplatin

9-ING-41 plus Carboplatin; 9-ING-41 plus Paclitaxel/Carboplatin

Nab paclitaxel. DRUG

Nab-paclitaxel 125 mg/m2 intravenously on Days 1, 8 and 15 of a 28-day cycle

Also known as: Abraxane, Protein-bound paclitaxel, Nanoparticle albumin-bound paclitaxel

9-ING-41 plus nab paclitaxel Gemcitabine

Paclitaxel. DRUG

Paclitaxel 175 mg/m2 intravenously over 3 hours on Day 1 of a 21-day cycle.

Also known as: Taxol

9-ING-41 plus Paclitaxel/Carboplatin

Gemcitabine - 28 day cycle DRUG

Gemcitabine 1000 mg/m2 intravenously over 30-minutes on Days 1, 8 and 15 of a 28-day cycle

Also known as: Gemzar

9-ING-41 plus nab paclitaxel Gemcitabine

Irinotecan DRUG

Irinotecan 350 mg/m2 intravenously over 90-minutes on Day 1 of a 21-day cycle

Also known as: Camptosar

9-ING-41 plus Irinotecan

Eligibility Criteria

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

You may qualify if:

• Patient -
• Is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures.
• Is aged ≥ 18 years
• Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
• Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
• Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
• Malignancy has relapsed after standard therapy
• Malignancy for which there is no standard therapy that improves survival by at least 3 months
• Has evaluable tumor(s) by standard radiological and/or laboratory assessments as applicable to their malignancy - in Part 3, patients with solid tumors must have least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 criteria, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI). In the case of patients with glioblastoma multiforme (GBM) or other central nervous system (CNS) tumors, the tumor must be measurable, defined as a clearly enhancing tumor with at two perpendicular diameters at entry equal or superior to 1cm.
• Has laboratory function within specified parameters (may be repeated):
• Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 500/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 50,000/mL
• Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 3 (≤ 5 X the upper limit of normal (ULN) in the setting of liver metastasis or infiltration with malignant cells) x ULN; bilirubin ≤ 1.5 x ULN
• Adequate renal function: creatinine clearance ≥ 60 mL/min (Cockcroft and Gault)
• Adequate blood coagulation: international normalized ratio (INR) ≤ 2.3
• Serum amylase and lipase ≤ 1.5 x ULN

You may not qualify if:

• Patient -
• Is pregnant or lactating
• Is known to be hypersensitive to any of the components of 9-ING-41 or to the excipients used in its formulation
• Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as ≤ Grade 2 CTCAE Version 4.03
• Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, or stroke within 6 months of the first dose of 9-ING-41, or cardiac arrhythmia requiring medical treatment detected at screening
• Has had a myocardial infarction within 12 weeks of the first dose of 9-ING-41 or has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the investigator or study medical coordinator
• Has known symptomatic rapidly progressive brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Patients with stable asymptomatic brain metastases or leptomeningeal disease or slowly progressive disease are eligible provided that they have not required new treatments for this disease in a 28-day period before the first dose of study drug, and anticonvulsants and steroids are at a stable dose for a period of 14 days prior to the first dose of study drug
• Has had major surgery (not including placement of central lines) within 7 days prior to study entry or is planned to have major surgery during the course of the study (major surgery may be defined as any invasive operative procedure in which an extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered. In general, if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges), the surgery is considered major)
• Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation
• Has received an investigational anti-cancer drug in the 14-day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial
• Has a current active malignancy other than the target cancer
• Is considered to be a member of a vulnerable population (for example, prisoners)
• Is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures
• Is aged ≥ 18 years
• Has pathologically confirmed metastatic pancreatic cancer AND is previously untreated with systemic agents in the recurrence/metastatic setting.

Sponsors & Collaborators

• Actuate Therapeutics Inc.: lead

Study Sites (66)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Arizona Oncology Associates

Tucson, Arizona, 85704, United States

Location

The University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

University of California Irvine Health

Orange, California, 92868, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Christiana Care Health Services

Newark, Delaware, 19709, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

Florida Cancer Specialists - South

Fort Myers, Florida, 33901, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Florida Cancer Specialists - North

St. Petersburg, Florida, 33705, United States

Location

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States

Location

Des Moines Oncology Research Association

Des Moines, Iowa, 50309, United States

Location

Kansas University Cancer Center

Kansas City, Kansas, 66160, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MetroMetro-Minnesota Community Oncology Research Consortium (MMCORC)

Minneapolis, Minnesota, 55416, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89128, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Capital Health Medical Center/ Hopewell

Pennington, New Jersey, 08534, United States

Location

MD Anderson Cancer Center at Cooper

Voorhees Township, New Jersey, 08043, United States

Location

Columbia University- Irving Medical Center

New York, New York, 10032, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Prisma Health Cancer Institute

Greenville, South Carolina, 26905, United States

Location

Sanford Research

Sioux Falls, South Dakota, 57105, United States

Location

West Cancer Center

Germantown, Tennessee, 38138, United States

Location

Baptist Clinical Research Institute

Memphis, Tennessee, 38120, United States

Location

Sarah Cannon Research Institute- Tennessee Oncology-Nashville

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Texas Oncology- Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84124, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

UZA- Antwerpen

Edegem, Antwerp, 2650, Belgium

Location

Imelda VZW

Bonheiden, 2820, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

Greenfield Park, Quebec, G4V 2H1, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Center Hospitalier Regional Universitaire de Besancon - Site Jean Minjoz

Besançon, Bourgogne-Franche-Comté, 25030, France

Location

CHRU Brest Hopital Morvan

Brest, Brittany Region, 29200, France

Location

Hopital Claude Huriez

Lille, Hauts-de-France, 59037, France

Location

Institute de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

Institut Bergonie

Bordeaux, Nouvelle-Aquitaine, 33076, France

Location

Insitut de Cancerologie de l'Ouest

Saint-Herblain, Pays de la Loire Region, 44800, France

Location

Hopital de la Timone

Marseille, 13005, France

Location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Fundacao Champalimaud

Lisbon, 1400-038, Portugal

Location

Hospital Da Luz

Lisbon, 1500-650, Portugal

Location

Centro Hospitalar Universitario Sao Joao

Porto, 4200-319, Portugal

Location

Vall d'Hebron Institute of Oncology

Barcelona, 08035, Spain

Location

Institut Catala d'Oncologia

Barcelona, 8908, Spain

Location

Hospital Clinico U San Carlos (HSC)

Madrid, 28050, Spain

Location

START Madrid-HM CIOCC Hospital Universitario

Madrid, 28050, Spain

Location

INCLIVA University of Valencia

Valencia, 46010, Spain

Location

Related Publications (15)

• Ugolkov AV, Bondarenko GI, Dubrovskyi O, Berbegall AP, Navarro S, Noguera R, O'Halloran TV, Hendrix MJ, Giles FJ, Mazar AP. 9-ING-41, a small-molecule glycogen synthase kinase-3 inhibitor, is active in neuroblastoma. Anticancer Drugs. 2018 Sep;29(8):717-724. doi: 10.1097/CAD.0000000000000652.

  PMID: 29846250 BACKGROUND

• Karmali R, Chukkapalli V, Gordon LI, Borgia JA, Ugolkov A, Mazar AP, Giles FJ. GSK-3beta inhibitor, 9-ING-41, reduces cell viability and halts proliferation of B-cell lymphoma cell lines as a single agent and in combination with novel agents. Oncotarget. 2017 Nov 11;8(70):114924-114934. doi: 10.18632/oncotarget.22414. eCollection 2017 Dec 29.

  PMID: 29383130 BACKGROUND

• Ugolkov A, Qiang W, Bondarenko G, Procissi D, Gaisina I, James CD, Chandler J, Kozikowski A, Gunosewoyo H, O'Halloran T, Raizer J, Mazar AP. Combination Treatment with the GSK-3 Inhibitor 9-ING-41 and CCNU Cures Orthotopic Chemoresistant Glioblastoma in Patient-Derived Xenograft Models. Transl Oncol. 2017 Aug;10(4):669-678. doi: 10.1016/j.tranon.2017.06.003. Epub 2017 Jun 30.

  PMID: 28672195 BACKGROUND

• Ugolkov A, Gaisina I, Zhang JS, Billadeau DD, White K, Kozikowski A, Jain S, Cristofanilli M, Giles F, O'Halloran T, Cryns VL, Mazar AP. GSK-3 inhibition overcomes chemoresistance in human breast cancer. Cancer Lett. 2016 Oct 1;380(2):384-392. doi: 10.1016/j.canlet.2016.07.006. Epub 2016 Jul 14.

  PMID: 27424289 BACKGROUND

• Pal K, Cao Y, Gaisina IN, Bhattacharya S, Dutta SK, Wang E, Gunosewoyo H, Kozikowski AP, Billadeau DD, Mukhopadhyay D. Inhibition of GSK-3 induces differentiation and impaired glucose metabolism in renal cancer. Mol Cancer Ther. 2014 Feb;13(2):285-96. doi: 10.1158/1535-7163.MCT-13-0681. Epub 2013 Dec 10.

  PMID: 24327518 BACKGROUND

• Walz A, Ugolkov A, Chandra S, Kozikowski A, Carneiro BA, O'Halloran TV, Giles FJ, Billadeau DD, Mazar AP. Molecular Pathways: Revisiting Glycogen Synthase Kinase-3beta as a Target for the Treatment of Cancer. Clin Cancer Res. 2017 Apr 15;23(8):1891-1897. doi: 10.1158/1078-0432.CCR-15-2240. Epub 2017 Jan 4.

  PMID: 28053024 BACKGROUND

• Ugolkov AV, Matsangou M, Taxter TJ, O'Halloran TV, Cryns VL, Giles FJ, Mazar AP. Aberrant expression of glycogen synthase kinase-3beta in human breast and head and neck cancer. Oncol Lett. 2018 Nov;16(5):6437-6444. doi: 10.3892/ol.2018.9483. Epub 2018 Sep 21.

  PMID: 30405781 BACKGROUND

• Sahin I, Eturi A, De Souza A, Pamarthy S, Tavora F, Giles FJ, Carneiro BA. Glycogen synthase kinase-3 beta inhibitors as novel cancer treatments and modulators of antitumor immune responses. Cancer Biol Ther. 2019;20(8):1047-1056. doi: 10.1080/15384047.2019.1595283. Epub 2019 Apr 12.

  PMID: 30975030 BACKGROUND

• Wu X, Stenson M, Abeykoon J, Nowakowski K, Zhang L, Lawson J, Wellik L, Li Y, Krull J, Wenzl K, Novak AJ, Ansell SM, Bishop GA, Billadeau DD, Peng KW, Giles F, Schmitt DM, Witzig TE. Targeting glycogen synthase kinase 3 for therapeutic benefit in lymphoma. Blood. 2019 Jul 25;134(4):363-373. doi: 10.1182/blood.2018874560. Epub 2019 May 17.

  PMID: 31101621 BACKGROUND

• Ding L, Madamsetty VS, Kiers S, Alekhina O, Ugolkov A, Dube J, Zhang Y, Zhang JS, Wang E, Dutta SK, Schmitt DM, Giles FJ, Kozikowski AP, Mazar AP, Mukhopadhyay D, Billadeau DD. Glycogen Synthase Kinase-3 Inhibition Sensitizes Pancreatic Cancer Cells to Chemotherapy by Abrogating the TopBP1/ATR-Mediated DNA Damage Response. Clin Cancer Res. 2019 Nov 1;25(21):6452-6462. doi: 10.1158/1078-0432.CCR-19-0799. Epub 2019 Sep 18.

  PMID: 31533931 BACKGROUND

• Jeffers A, Qin W, Owens S, Koenig KB, Komatsu S, Giles FJ, Schmitt DM, Idell S, Tucker TA. Glycogen Synthase Kinase-3beta Inhibition with 9-ING-41 Attenuates the Progression of Pulmonary Fibrosis. Sci Rep. 2019 Dec 12;9(1):18925. doi: 10.1038/s41598-019-55176-w.

  PMID: 31831767 BACKGROUND

• Kuroki H, Anraku T, Kazama A, Bilim V, Tasaki M, Schmitt D, Mazar AP, Giles FJ, Ugolkov A, Tomita Y. 9-ING-41, a small molecule inhibitor of GSK-3beta, potentiates the effects of anticancer therapeutics in bladder cancer. Sci Rep. 2019 Dec 27;9(1):19977. doi: 10.1038/s41598-019-56461-4.

  PMID: 31882719 BACKGROUND

• Anraku T, Kuroki H, Kazama A, Bilim V, Tasaki M, Schmitt D, Mazar A, Giles FJ, Ugolkov A, Tomita Y. Clinically relevant GSK-3beta inhibitor 9-ING-41 is active as a single agent and in combination with other antitumor therapies in human renal cancer. Int J Mol Med. 2020 Feb;45(2):315-323. doi: 10.3892/ijmm.2019.4427. Epub 2019 Dec 12.

  PMID: 31894292 BACKGROUND

• Hsu A, Huntington KE, De Souza A, Zhou L, Olszewski AJ, Makwana NP, Treaba DO, Cavalcante L, Giles FJ, Safran H, El-Deiry WS, Carneiro BA. Clinical activity of 9-ING-41, a small molecule selective glycogen synthase kinase-3 beta (GSK-3beta) inhibitor, in refractory adult T-Cell leukemia/lymphoma. Cancer Biol Ther. 2022 Dec 31;23(1):417-423. doi: 10.1080/15384047.2022.2088984.

  PMID: 35815408 DERIVED

• Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

  PMID: 31401903 DERIVED

MeSH Terms

Conditions

Neoplasms; Pancreatic Neoplasms; Sarcoma; Kidney Neoplasms; Lymphoma, Non-Hodgkin; Neoplasm Metastasis; Bone Neoplasms; Breast Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Glioma; Hereditary Sensory and Autonomic Neuropathies; Leukemia-Lymphoma, Adult T-Cell

Interventions

3-(5-fluorobenzofuran-3-yl)-4-(5-methyl-5H-(1,3)dioxolo(4,5-f)indol-7-yl)-pyrrole-2,5-dione; Gemcitabine; Doxorubicin; liposomal doxorubicin; Lomustine; Carboplatin; Taxes; Albumin-Bound Paclitaxel; Paclitaxel; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Coordination Complexes; Economics; Health Care Economics and Organizations; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Camptothecin; Alkaloids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2018
• First Posted: September 20, 2018
• Study Start: January 4, 2019
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (3); ES (5); FR (7); BE (4); US (40); CA (6); NL (1)