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Selinexor With Multiple Standard Chemotherapy Regimens in Treating Patients With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02419495
Recruitment Status : Recruiting
First Posted : April 17, 2015
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase Ib trial studies the side effects and best dose of selinexor when given together with several different standard chemotherapy 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 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.

Condition or disease Intervention/treatment Phase
Advanced Malignant Neoplasm Recurrent Malignant Neoplasm Refractory Malignant Neoplasm Drug: Capecitabine Drug: Carboplatin Drug: Cyclophosphamide Drug: Doxorubicin Hydrochloride Drug: Eribulin Mesylate Drug: Fluorouracil Drug: Irinotecan Hydrochloride Other: Laboratory Biomarker Analysis Drug: Leucovorin Calcium Biological: Nivolumab Drug: Olaparib Drug: Oxaliplatin Drug: Paclitaxel Biological: Pembrolizumab Drug: Pemetrexed Disodium Drug: Selinexor Drug: Topotecan Hydrochloride Phase 1

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 247 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy Agents in Patients With Advanced Malignancies
Actual Study Start Date : June 26, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Arm A (selinexor, carboplatin) (ARM CLOSED)
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 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients can continue single agent selinexor until disease progression.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm B (selinexor, paclitaxel)
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 courses of combination treatment, patients can continue single agent selinexor until disease progression.
Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm C (selinexor, eribulin mesylate)
Patients receive selinexor PO on days 1, 8, and 15 and eribulin mesylate IV over 1 hour on days 1 and 8. Combination treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients can continue single agent selinexor until disease progression.
Drug: Eribulin Mesylate
Given IV
Other Names:
  • B1939 Mesylate
  • E7389
  • ER-086526
  • Halaven
  • Halichondrin B Analog

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm D (selinexor, doxorubicin, cyclophosphamide) (ARM CLOSED)
Patients receive selinexor PO on days 1, 8, and 15, doxorubicin hydrochloride IV over 90 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients can continue single agent selinexor until disease progression.
Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-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
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm E (selinexor, carboplatin, paclitaxel) (ARM CLOSED)
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 courses depending con cancer type (6 courses for non-small cell lung cancer, up to 8 courses for ovarian cancer and other histological malignancies) in the absence of disease progression or unacceptable toxicity. After 6 to 8 courses, patients can continue single agent selinexor until disease progression.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm F (selinexor, carboplatin, pemetrexed) (ARM CLOSED)
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 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients can continue single agent selinexor until disease progression.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Pemetrexed Disodium
Given IV
Other Names:
  • Alimta
  • LY231514
  • N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm G (selinexor, topotecan hydrochloride) (ARM CLOSED)
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 courses in the absence of disease progression or unacceptable toxicity. After 8 courses, patients can continue single agent selinexor until disease progression.
Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Drug: Topotecan Hydrochloride
Given IV
Other Names:
  • Hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • Topotecan HCl
  • topotecan hydrochloride (oral)

Experimental: Arm H (selinexor, FOLFIRI) (ARM CLOSED)
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 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, patients can continue single agent selinexor until disease progression.
Drug: Fluorouracil
Given IV
Other Names:
  • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
  • 5-Fluorouracil
  • 5-Fluracil
  • 5-FU
  • AccuSite
  • Carac
  • Fluoro Uracil
  • Fluouracil
  • Flurablastin
  • Fluracedyl
  • Fluracil
  • Fluril
  • Fluroblastin
  • Ribofluor
  • Ro 2-9757
  • Ro-2-9757

Drug: Irinotecan Hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • Camptothecin 11
  • Camptothecin-11
  • CPT 11
  • CPT-11
  • Irinomedac
  • U-101440E

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Leucovorin Calcium
Given IV
Other Names:
  • 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

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm I (selinexor, irinotecan hydrochloride) (ARM CLOSED)
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 courses in the absence of disease progression or unacceptable toxicity. After 8 courses, patients can continue single agent selinexor until disease progression.
Drug: Irinotecan Hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • Camptothecin 11
  • Camptothecin-11
  • CPT 11
  • CPT-11
  • Irinomedac
  • U-101440E

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm J (selinexor, capecitabine, oxaliplatin) (ARM CLOSED)
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 courses in the absence of disease progression or unacceptable toxicity. After 8 courses, patients can continue single agent selinexor until disease progression.
Drug: Capecitabine
Given PO
Other Names:
  • Ro 09-1978/000
  • Xeloda

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Oxaliplatin
Given IV
Other Names:
  • 1-OHP
  • Ai Heng
  • Aiheng
  • Dacotin
  • Dacplat
  • Diaminocyclohexane Oxalatoplatinum
  • Eloxatin
  • Eloxatine
  • JM-83
  • Oxalatoplatin
  • Oxalatoplatinum
  • RP 54780
  • RP-54780
  • SR-96669

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm K (selinexor, olaparib)
Patients receive selinexor PO on days 1, 8, 15, and 22 and olaparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Olaparib
Given PO
Other Names:
  • AZD2281
  • KU-0059436
  • Lynparza
  • PARP Inhibitor AZD2281

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm L (selinexor, pembrolizumab)
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. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330

Experimental: Arm M (selinexor, nivolumab
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. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo

Drug: Selinexor
Given PO
Other Names:
  • CRM1 Nuclear Export Inhibitor KPT-330
  • KPT-330
  • Selective Inhibitor of Nuclear Export KPT-330
  • SINE KPT-330




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 3 years ]
    Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.


Secondary Outcome Measures :
  1. Disease control rate (complete response, partial response + stable disease for at least 6 months, assessed according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) [ Time Frame: Up to 3 years ]
    Estimated separately for each cohort with appropriate 95% confidence intervals.

  2. Objective tumor response rate (complete response + partial response), assessed according to RECIST 1.1 criteria [ Time Frame: Up to 3 years ]
    Estimated separately for each cohort with appropriate 95% confidence intervals.

  3. Progression-free survival (PFS) [ Time Frame: 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 ]
    PFS distribution will be estimated using the Kaplan-Meier product limit method and summary measures such as the median value and probabilities will be reported at selected times (with appropriate 95% confidence intervals).

  4. Overall survival (OS) [ Time Frame: Up to 3 years ]
    OS distribution will be estimated using the Kaplan-Meier product limit method and summary measures such as the median value and probabilities will be reported at selected times (with appropriate 95% confidence intervals).

  5. Incidence of adverse events [ Time Frame: Up to 3 years ]
    Will be graded according to NCI CTCAE version 4.03.


Other Outcome Measures:
  1. Serial mutations in biopsies [ Time Frame: Up to 30 days after last dose of treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed malignant neoplasms (not including hematological malignancies and brain tumors) untreated or previously treated requiring further treatment; patients must be refractory to, and intolerant of, established therapy known to provide clinical benefit for their condition; patients in Arm L (pembrolizumab) and Arm M (nivolumab) can be treatment naive and do not have to fail first line nivolumab or pembrolizumab if they have disease where pembrolizumab or nivolumab are Food and Drug Administration (FDA) approved for the first-line setting
  • For all arms except Arm L (pembrolizumab) and Arm M (nivolumab), 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 and Arm M nivolumab and expansion cohorts for all arms, platelets >= 100 x 10^9/L)
  • Hemoglobin >= 10 g/dL (for Arm L pembrolizumab and Arm M nivolumab and expansion cohorts for all arms, hemoglobin >= 9 g/dL
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
  • White blood cells (WBC) >= 3 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)
  • Albumin >= 3 g/dL
  • Renal function defined as a calculated or measured glomerular filtration rate (GFR) >= 30 mL/min
  • The patient has recovered to grade =< 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 (NCI-CTCAE v4.03) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies, with the exception of alopecia; the exceptions for such effects are allowed lab values of =< grade 2 specified elsewhere in these inclusion criteria
  • Life expectancy of at least 12 weeks
  • Able to swallow and retain oral medication
  • Patients must give informed consent according to the rules and regulations of the individual participating sites
  • Negative serum pregnancy test in women of childbearing potential within 7 days of first dose of treatment and patients of child-bearing potential must agree to use effective contraception during/after 3 months post dose; a woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant; this includes women on oral, injectable or mechanical contraception; women who are single and women whose male sexual partners have been vasectomized or whose male sexual partners have received or are utilizing mechanical contraceptive devices
  • For the Arm B (paclitaxel) expansion cohort, patients must have ovarian carcinoma
  • For Arm C (eribulin) expansion cohort, patients must have triple negative breast cancer (eribulin naive)
  • For Arm K (olaparib), patients must have pre-identified BRCA mutant cancer

Exclusion Criteria:

  • 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 and M), 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
  • Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to the first dose; active infection with concurrent treatment is acceptable only if the patient is clinically stable
  • Significantly diseased (as determined by the principal investigator [PI] or treating physician) or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea
  • Treatment with an investigational anti-cancer study drug within 3 weeks prior to study drug administration date
  • Concurrent therapy with approved or investigational anticancer therapeutics
  • Medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Men whose partner is a woman of child-bearing potential, (i.e. biologically able to conceive), and who is not employing two forms of highly effective contraception; highly effective contraception (e.g. male condom with spermicide, diaphragm with spermicide, intra-uterine device) must be used by both sexes during the study and must be continued for 3 months after the end of study treatment; women of child-bearing potential is defined as sexually mature women who are not surgically sterile or who have not been naturally postmenopausal for at least 12 consecutive months (e.g., who has had menses any time in the preceding 12 consecutive months)
  • For Arms L (pembrolizumab) and M (nivolumab), subjects with an active, known or suspected autoimmune disease; subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • For Arms L (pembrolizumab) and M (nivolumab), subjects receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or other form of immunosuppressive therapy within 7 days before the first dose of study treatment; use of inhaled or topical steroids or systemic corticosteroids =< 10 mg is permitted
  • For Arms L (pembrolizumab) and M (nivolumab), history of a prior grade 3 or 4 immune-related adverse event (irAE) or any grade ocular irAE from prior immunotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419495


Contacts
Layout table for location contacts
Contact: Aung Naing 713-563-1930 anaing@mdanderson.org

Locations
Layout table for location information
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Aung Naing    713-563-1930      
Principal Investigator: Aung Naing         
MD Anderson Regional Care Center-Katy Recruiting
Houston, Texas, United States, 77094
Contact: Aung Naing    713-563-1930      
Principal Investigator: Aung Naing         
MD Anderson Regional Care Center-Bay Area Recruiting
Nassau Bay, Texas, United States, 77058
Contact: Aung Naing    713-563-1930      
Principal Investigator: Aung Naing         
MD Anderson Regional Care Center-Sugar Land Recruiting
Sugar Land, Texas, United States, 77478
Contact: Aung Naing    713-563-1930      
Principal Investigator: Aung Naing         
MD Anderson Regional Care Center-The Woodlands Recruiting
The Woodlands, Texas, United States, 77384
Contact: Aung Naing    713-563-1930      
Principal Investigator: Aung Naing         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Aung Naing M.D. Anderson Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02419495     History of Changes
Other Study ID Numbers: 2014-0640
NCI-2015-00693 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0640 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Paclitaxel
Camptothecin
Halichondrin B
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Capecitabine
Oxaliplatin
Pembrolizumab
Doxorubicin
Liposomal doxorubicin
Nivolumab
Irinotecan
Fluorouracil
Pemetrexed
Topotecan
Olaparib
Calcium
Calcium, Dietary
Leucovorin
Levoleucovorin
Folic Acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents