Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies

NCT02419495 | Terminated Phase 1 FDA Drug

• 2 other identifiers: 2014-0640NCI-2015-00693
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 5

Brief Summary

This phase Ib trial studies the side effects and best dose of selinexor when given together with several different standard chemotherapy or immunotherapy regimens in treating patients with malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Selinexor may stop the growth of cancer cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Studying selinexor with different standard chemotherapy or immunotherapy regimens may help doctors learn the side effects and best dose of selinexor that can be given with different types of treatments in one study.

Conditions

Advanced Malignant Solid Neoplasm; Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Fallopian Tube Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Melanoma; Metastatic Renal Cell Carcinoma; Ovarian Carcinoma; Pathologic Stage III Cutaneous Melanoma AJCC v8; Pathologic Stage IIIA Cutaneous Melanoma AJCC v8; Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IIID Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Primary Peritoneal Carcinoma; Stage III Lung Cancer AJCC v8; Stage III Renal Cell Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Triple-Negative Breast Carcinoma; Unresectable Lung Non-Small Cell Carcinoma; Unresectable Melanoma; Unresectable Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

  Up to 3 years

Secondary Outcomes (5)

• Disease control rate (complete response, partial response + stable disease for at least 6 months

  Up to 3 years

• Objective tumor response rate (complete response + partial response)

  Up to 3 years

• Progression-free survival (PFS)

  The time between the course 1 start date and the date of disease progression or death, whichever is reported first, assessed up to 3 years

• Overall survival (OS)

  Up to 3 years

• Incidence of adverse events

  Up to 3 years

Other Outcomes (3)

• Serial mutations in biopsies

  Up to 30 days after last dose of treatment

• Severity of nausea and vomiting

  Up to 3 years

• Change in weight

  Baseline up to 3 years

Study Arms (15)

Arm A (selinexor, carboplatin) (ARM CLOSED)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

Drug: Carboplatin; Drug: Selinexor

Arm B (selinexor, paclitaxel)

EXPERIMENTAL

Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) on days 1-14. Patients then receive selinexor PO on days 1, 3, 8 and 10 and paclitaxel IV over 3 hours on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After 8 cycles of combination treatment, patients can continue single agent selinexor until disease progression.

Drug: Paclitaxel; Drug: Selinexor

Arm C (selinexor, eribulin)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8, and 15 and eribulin IV over 1 hour on days 1 and 8. Combination treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

Drug: Eribulin; Drug: Selinexor

Arm D (selinexor, doxorubicin, cyclophosphamide) (ARM CLOSED)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8, and 15, doxorubicin IV over 90 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Selinexor

Arm E (selinexor, carboplatin, paclitaxel) (ARM CLOSED)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for up to 8 cycles depending con cancer type (6 cycles for non-small cell lung cancer, up to 8 cycles for ovarian cancer and other histological malignancies) in the absence of disease progression or unacceptable toxicity. After 6 to 8 cycles, patients can continue single agent selinexor until disease progression.

Drug: Carboplatin; Drug: Paclitaxel; Drug: Selinexor

Arm F (selinexor, carboplatin, pemetrexed) (ARM CLOSED)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8, and 15 and carboplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

Drug: Carboplatin; Drug: Pemetrexed; Drug: Selinexor

Arm G (selinexor, topotecan hydrochloride) (ARM CLOSED)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8, and 15 and topotecan hydrochloride IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients can continue single agent selinexor until disease progression.

Drug: Selinexor; Drug: Topotecan

Arm H (selinexor, FOLFIRI) (ARM CLOSED)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8, 15 and 22, irinotecan hydrochloride IV over 90 minutes, fluorouracil IV continuously over 48 hours and leucovorin calcium IV over 2 hours on days 1 and 15. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients can continue single agent selinexor until disease progression.

Drug: Fluorouracil; Drug: Irinotecan Hydrochloride; Drug: Leucovorin Calcium; Drug: Selinexor

Arm I (selinexor, irinotecan hydrochloride) (ARM CLOSED)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8 and 15 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients can continue single agent selinexor until disease progression.

Drug: Irinotecan Hydrochloride; Drug: Selinexor

Arm J (selinexor, capecitabine, oxaliplatin) (ARM CLOSED)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8 and 15, capecitabine PO twice daily (BID) on days 1-14 and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After 8 cycles, patients can continue single agent selinexor until disease progression.

Drug: Capecitabine; Drug: Oxaliplatin; Drug: Selinexor

Arm K (selinexor, olaparib) (ARM CLOSED)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8, 15, and 22 and olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Olaparib; Drug: Selinexor

Arm L (selinexor, pembrolizumab)

EXPERIMENTAL

Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Biological: Pembrolizumab; Drug: Selinexor

Arm M (selinexor, nivolumab

EXPERIMENTAL

Patients receive selinexor PO twice weekly (e.g. Monday/Wednesday or Tuesday/Thursday or Wednesday/Friday or Thursday/Saturday or Friday/Sunday) and nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: Nivolumab; Drug: Selinexor

Arm P (selinexor, nivolumab, ipilimumab)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8, 15, 22, 29, and 36, nivolumab IV over 30 minutes on days 1, 15, and 29, and ipilimumab PO QD on day 1. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Biological: Ipilimumab; Biological: Nivolumab; Drug: Selinexor

Arms N and O (selinexor, nivolumab, ipilimumab)

EXPERIMENTAL

Patients receive selinexor PO on days 1, 8, and 15, nivolumab IV over 30 minutes on day 1, and ipilimumab PO QD on day 1. Cycles repeat every 3 weeks for 4 cycles. Starting cycle 5, patients receive selinexor PO on days 1, 8, 15, and 22 and nivolumab IV over 30 minutes on day 1. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Biological: Ipilimumab; Biological: Nivolumab; Drug: Selinexor

Interventions

Capecitabine DRUG

Given PO

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

Arm J (selinexor, capecitabine, oxaliplatin) (ARM CLOSED)

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

Arm A (selinexor, carboplatin) (ARM CLOSED); Arm E (selinexor, carboplatin, paclitaxel) (ARM CLOSED); Arm F (selinexor, carboplatin, pemetrexed) (ARM CLOSED)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719

Arm D (selinexor, doxorubicin, cyclophosphamide) (ARM CLOSED)

Doxorubicin DRUG

Given IV

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

Arm D (selinexor, doxorubicin, cyclophosphamide) (ARM CLOSED)

Eribulin DRUG

Given IV

Also known as: ER-086526

Arm C (selinexor, eribulin)

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

Arm H (selinexor, FOLFIRI) (ARM CLOSED)

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

Arm P (selinexor, nivolumab, ipilimumab); Arms N and O (selinexor, nivolumab, ipilimumab)

Irinotecan Hydrochloride DRUG

Given IV

Also known as: Campto, Camptosar, Camptothecin 11, Camptothecin-11, CPT 11, CPT-11, Irinomedac, Irinotecan Hydrochloride Trihydrate, Irinotecan Monohydrochloride Trihydrate, U-101440E

Arm H (selinexor, FOLFIRI) (ARM CLOSED); Arm I (selinexor, irinotecan hydrochloride) (ARM CLOSED)

Leucovorin Calcium DRUG

Given IV

Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

Arm H (selinexor, FOLFIRI) (ARM CLOSED)

Nivolumab BIOLOGICAL

Given IV

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

Arm M (selinexor, nivolumab; Arm P (selinexor, nivolumab, ipilimumab); Arms N and O (selinexor, nivolumab, ipilimumab)

Olaparib DRUG

Given PO

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

Arm K (selinexor, olaparib) (ARM CLOSED)

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

Arm J (selinexor, capecitabine, oxaliplatin) (ARM CLOSED)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Arm B (selinexor, paclitaxel); Arm E (selinexor, carboplatin, paclitaxel) (ARM CLOSED)

Pembrolizumab BIOLOGICAL

Given IV

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

Arm L (selinexor, pembrolizumab)

Pemetrexed DRUG

Given IV

Also known as: MTA, Multitargeted Antifolate, Pemfexy

Arm F (selinexor, carboplatin, pemetrexed) (ARM CLOSED)

Selinexor DRUG

Given PO

Also known as: ATG-010, CRM1 Nuclear Export Inhibitor KPT-330, KPT-330, Selective Inhibitor of Nuclear Export KPT-330, SINE KPT-330, Xpovio

Arm A (selinexor, carboplatin) (ARM CLOSED); Arm B (selinexor, paclitaxel); Arm C (selinexor, eribulin); Arm D (selinexor, doxorubicin, cyclophosphamide) (ARM CLOSED); Arm E (selinexor, carboplatin, paclitaxel) (ARM CLOSED); Arm F (selinexor, carboplatin, pemetrexed) (ARM CLOSED); Arm G (selinexor, topotecan hydrochloride) (ARM CLOSED); Arm H (selinexor, FOLFIRI) (ARM CLOSED); Arm I (selinexor, irinotecan hydrochloride) (ARM CLOSED); Arm J (selinexor, capecitabine, oxaliplatin) (ARM CLOSED); Arm K (selinexor, olaparib) (ARM CLOSED); Arm L (selinexor, pembrolizumab); Arm M (selinexor, nivolumab; Arm P (selinexor, nivolumab, ipilimumab); Arms N and O (selinexor, nivolumab, ipilimumab)

Topotecan DRUG

Given IV

Also known as: Hycamptamine, Topotecan Lactone

Arm G (selinexor, topotecan hydrochloride) (ARM CLOSED)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed malignant neoplasms (not including hematological malignancies and brain tumors) untreated or previously treated requiring further treatment; patients in Arm L (pembrolizumab), Arm M (nivolumab), and Arms N, O, P (nivolumab and ipilimumab) that have Food and Drug Administration (FDA)-approved indications for nivolumab, ipilimumab, and pembrolizumab do not have to fail first line nivolumab, ipilimumab, or pembrolizumab, and these patients may be treatment naïve if they have disease where pembrolizumab or nivolumab are FDA approved for the first-line setting
• For all arms except Arm L (pembrolizumab), Arm M (nivolumab), and Arms N, O, P (nivolumab and ipilimumab) patients must have failed prior standard curative chemotherapy for their disease; subjects must have failed, be intolerant to, or be ineligible for any potentially curative approved treatment, irrespective of line of therapy
• Patients must have measurable disease (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• The patient must be recovered from a prior major surgery; the major surgery must be performed at least 4 weeks prior to consent date
• Platelets \>= 125 x 10\^9/L (For Arm L pembrolizumab, Arm M nivolumab and Arms N, O, P \[nivolumab and ipilimumab\] and expansion cohorts for all arms, platelets \>= 100 x 10\^9/L)
• Hemoglobin \>= 10 g/dL (For Arm L pembrolizumab, Arm M nivolumab and Arms N, O, P \[nivolumab and ipilimumab\] and expansion cohorts for all arms, hemoglobin \>= 9 g/dL)
• Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (For Arm L pembrolizumab, Arm M nivolumab and Arms N, O, P \[nivolumab and ipilimumab\], ANC \>= 1.0 x 10\^9/L)
• Transfusions and growth factors are allowed
• Alanine transaminase (alanine aminotransferase \[ALT\]) =\< 2 x upper normal limit (ULN) (in the expansion cohort, patients with known liver involvement may have ALT =\< 5 x ULN); aspartate aminotransferase (AST) =\< 2 x ULN (in the expansion cohort, patients with known liver involvement may have AST =\< 5 x ULN)
• Alkaline phosphatase \< 4 x ULN
• Total bilirubin =\< 2 x ULN (in the expansion cohort, patients with Gilbert's syndrome \[hereditary indirect hyperbilirubinemia\] who must have a total bilirubin of =\< 3 x ULN)
• Renal function defined as a calculated or measured glomerular filtration rate (GFR) \>= 30 mL/min. For patients with renal cell carcinoma (RCC), the GFR may be defined as \>= 25 mL/min
• Life expectancy of at least 12 weeks
• Able to swallow and retain oral medication

You may not qualify if:

• Evidence of complete or partial bowel obstruction
• Patients with primary central nervous system (CNS) tumor or CNS tumor involvement; however, patients with metastatic CNS tumors may participate in this study if the patient is:
• \> 4 weeks from prior therapy completion (including radiation and/or surgery)
• Clinically stable with respect to the CNS tumor at the time of study entry
• Not receiving steroid therapy in treating CNS tumor or CNS tumor involvement
• Not receiving anti-convulsive medications (that were started for brain metastases)
• Need of total parenteral nutrition
• Prior treatment with an agent targeting the exportin
• Allergic to selinexor or any of the chemotherapy intended to receive
• Pregnancy or lactation
• Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) =\< 3 weeks prior to study drug administration date
• Chemotherapy, or immunotherapy or any other systemic anticancer therapy =\< 3 weeks prior to study drug administration date; patients receiving anti-PD-1 treatment, and continue to receiving this treatment in combination with selinexor (Arms L, M, N, O, and P), can start receiving the selinexor and anti-PD-1 combination without washout of the prior anti-PD-1 antibody
• Diagnosis or recurrence of invasive cancer other than the present cancer within 3 years (except basal or squamous cell carcinoma of the skin that has been definitively treated)
• Major surgery within four weeks before consent date
• Unstable cardiovascular function: symptomatic ischemia (chest pain of cardiac origin), or uncontrolled clinically significant conduction abnormalities (e.g. ventricular tachycardia on antiarrhythmics are excluded and 1st degree atrioventricular \[AV\] block or asymptomatic left anterior fascicular block \[LAFB\]/right bundle branch block \[RBBB\] will not be excluded), or congestive heart failure (CHF) of New York Heart Association (NYHA) class \>= 3, or myocardial infarction (MI) within 3 months of consent date

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson West Houston

Houston, Texas, 77079, United States

Location

MD Anderson League City

League City, Texas, 77573, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

Related Publications (6)

• Alhalabi O, Gouda MA, Milton DR, Momin HA, Yilmaz B, Stephen B, Ejezie CL, Moyers JT, Gurses SA, How J, Fu S, Rodon J, Hong DS, Piha-Paul SA, Subbiah V, Elena Dumbrava E, Karp DD, Janku F, Meric-Bernstam F, Tannir NM, Naing A. A Phase IB Trial of Selinexor in Combination With Immune Checkpoint Blockade in Patients With Advanced Renal Cell Carcinoma. Cancer Med. 2025 Feb;14(4):e70280. doi: 10.1002/cam4.70280.

  PMID: 39945382 DERIVED

• Gouda MA, Zarifa A, Yang Y, Stephen B, Gurses SA, Sprenger A, Tian Y, Derbala MH, Oliva IG, Meric-Bernstam F, Patel SP. Selinexor (KPT-330) in Combination with Immune Checkpoint Inhibition in Uveal Melanoma: A Phase 1B Trial. J Immunother Precis Oncol. 2025 Jan 15;8(1):82-88. doi: 10.36401/JIPO-24-10. eCollection 2025 Feb.

  PMID: 39816915 DERIVED

• Altan M, Tu J, Milton DR, Yilmaz B, Tian Y, Fossella FV, Mott FE, Blumenschein GR, Stephen B, Karp DD, Meric-Bernstam F, Heymach JV, Naing A. Safety, tolerability, and clinical activity of selinexor in combination with pembrolizumab in treatment of metastatic non-small cell lung cancer. Cancer. 2023 Sep 1;129(17):2685-2693. doi: 10.1002/cncr.34820. Epub 2023 May 2.

  PMID: 37129197 DERIVED

• Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Fu S, Subbiah V, Hong DS, Yap TA, Shah J, Milton DR, McQuinn L, Gong J, Tran Y, Carter BW, Colen R, Meric-Bernstam F, Naing A. Selinexor in combination with standard chemotherapy in patients with advanced or metastatic solid tumors. Exp Hematol Oncol. 2021 Dec 29;10(1):59. doi: 10.1186/s40164-021-00251-0.

  PMID: 34965890 DERIVED

• Thein KZ, Karp DD, Tsimberidou A, Gong J, Sulovic S, Shah J, Milton DR, Hong DS, Janku F, McQuinn L, Stephen BA, Colen R, Carter BW, Yap TA, Piha-Paul SA, Fu S, Meric-Bernstam F, Naing A. Selinexor in combination with carboplatin and paclitaxel in patients with advanced solid tumors: Results of a single-center, multi-arm phase Ib study. Invest New Drugs. 2022 Apr;40(2):290-299. doi: 10.1007/s10637-021-01188-1. Epub 2021 Sep 25.

  PMID: 34562230 DERIVED

• Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Zarifa A, Shah J, Milton DR, Bean S, McQuinn L, Gong J, Colen R, Carter BW, Subbiah V, Ogbonna DC, Pant S, Meric-Bernstam F, Naing A. Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study. Invest New Drugs. 2021 Oct;39(5):1357-1365. doi: 10.1007/s10637-021-01119-0. Epub 2021 Apr 28.

  PMID: 33909232 DERIVED

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Melanoma; Carcinoma, Renal Cell; Ovarian Neoplasms; Lung Neoplasms; Triple Negative Breast Neoplasms

Interventions

Capecitabine; Carboplatin; Cyclophosphamide; Doxorubicin; eribulin; Fluorouracil; dehydroftorafur; Ipilimumab; CTLA-4 Antigen; Irinotecan; Leucovorin; Nivolumab; olaparib; Oxaliplatin; Paclitaxel; Taxes; pembrolizumab; Pemetrexed; selinexor; Topotecan

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Neoplasms; Breast Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; 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; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Officials

• Aung Naing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: June 26, 2015
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: June 4, 2025

Record last verified: 2024-09

Locations

US (5)