Selective Inhibitor of Nuclear Export, Selinexor (KPT-330) in Combination With Paclitaxel and Carboplatin in Patients With Advanced Ovarian or Endometrial Cancers

Part of paid clinical trials in Middletown, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02269293
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
  • Carboplatin — DRUG
  • Selinexor — DRUG

Study Details

The purpose of this study is to test the safety of the investigational drug, selinexor (KPT-330), in combination with carboplatin and paclitaxel chemotherapy, where paclitaxel will be given at two different dosing schedules and selinexor will be given at two different dosing schedules. Carboplatin and paclitaxel chemotherapy is a commonly used therapy for the treatment of advanced or recurrent ovarian, fallopian tube, primary peritoneal, or endometrial cancer. The investigators want to find out what effects, good and/or bad, selinexor has on the patient and the cancer.

Key Dates

Start date
Oct 13, 2014
Status verified
Apr 2021
Primary completion
Apr 20, 2021
Completion
Apr 20, 2021

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen 1
    Paclitaxel 175 mg/m\^2 IV, Day 1 (administered over approximately 3 hours) Carboplatin AUC 5 IV, Day 1 (administered over approximately 30 minutes) Selinexor (to be taken orally once daily on days 1, 4, 8, 11, 15, and 18 of each chemotherapy cycle) The selinexor tablet should not be crushed and/or chewed.
  • Experimental: Regimen 2
    Paclitaxel 80 mg/m\^2 IV, Days 1, 8, 15 (administered over approximately 1 hour) Carboplatin AUC 5 IV, Day 1 (administered over approximately 30 minutes) Selinexor orally (to be taken orally once daily on days 1, 4, 8, 11, 15, and 18 of each chemotherapy cycle) The selinexor tablet should not be crushed and/or chewed.
  • Experimental: Regimen 3
    Paclitaxel 80 mg/m\^2 IV, Days 1, 8, 15 (administered over approximately 1 hour) Carboplatin AUC 5 IV, Day 1 (administered over approximately 30 minutes) Selinexor orally (to be taken orally once weekly on days 1, 8, and 15 of each chemotherapy cycle) The selinexor tablet should not be crushed and/or chewed.
  • Experimental: Regimen 4
    Paclitaxel and carboplatin will be delivered intravenously (IV) on day 1 of each cycle. Selinexor will be taken orally once a week on days 1, 8 and 15 of each chemotherapy cycle.

Primary Outcome Measure

maximum tolerated dose [ Time Frame: 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
Memoral Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in Middletown, NJ

By condition
Endometrial cancerOvarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Memoral Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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