PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Karyopharm Therapeutics Inc
Study ID
NCT02702492
Phase
PHASE1
Status
Terminated

Conditions

  • NHL
  • Solid Tumors

Eligibility Criteria

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

Interventions

  • KPT-9274 — DRUG
  • Niacin ER — DRUG
  • Nivolumab — DRUG

Study Details

This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL).

Key Dates

Start date
Jun 8, 2016
Status verified
Oct 2024
Primary completion
Jan 26, 2021
Completion
Jan 26, 2021

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: KPT-9274 10mg
    Participants received a 10 milligrams (mg) of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
  • Experimental: Part A: KPT-9274 20mg
    Participants received a 20mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
  • Experimental: Part A: KPT-9274 30mg
    Participants received a 30mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
  • Experimental: Part A: KPT-9274 40mg
    Participants received a 40mg of oral tablets of KPT-9274 three times a week every other day during each 28 day cycle.
  • Experimental: Part A: KPT-9274 40mg BIW
    Participants received KPT-9274 40mg of oral tablet biweekly (BIW) during each 28-day cycle.
  • Experimental: Part B: KPT-9274 30mg + Niacin 500mg
    Participants received KPT-9274 30mg of oral tablet along with a starting dose of 500mg niacin extended release (ER) orally three times a week every other day during each 28-day cycle.
  • Experimental: Part B: KPT-9274 40mg + Niacin 500mg
    Participants received KPT-9274 40mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
  • Experimental: Part B: KPT-9274 60mg + Niacin 500mg
    Participants received KPT-9274 60mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
  • Experimental: Part B: KPT-9274 80mg + Niacin 500mg
    Participants received KPT-9274 80mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
  • Experimental: Part B: KPT-9274 100mg + Niacin 500mg
    Participants received KPT-9274 100mg of oral tablet along with a starting dose of 500mg niacin ER orally three times a week every other day during each 28-day cycle.
  • Experimental: Part C: KPT-9274 20mg + Nivolumab 480mg
    Participants received KPT-9274 20mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
  • Experimental: Part C: KPT-9274 30mg + Nivolumab 480mg
    Participants received KPT-9274 30mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).
  • Experimental: Part C: KPT-9274 40mg + Nivolumab 480mg
    Participants received KPT-9274 40mg of oral tablet three times a week every other day during each 28-day cycle along with 480mg of nivolumab intravenous infusion on Day 1 of each cycle (once every 4-week cycle).

Primary Outcome Measure

Maximum Tolerated Dose (MTD) for KPT-9274 [ Time Frame: From start of study drug administration up to 44 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
UCLA HealthLos AngelesCalifornia90024-
University of Colorado Cancer CenterAuroraColorado80045-
Georgetown University, Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
Mayo Clinic RochesterRochesterMinnesota55905-
NYU-Laura & Isaac Perlmutter Cancer CenterNew YorkNew York100016-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
UCLA Health· Los Angeles, CAUniversity of Colorado Cancer Center· Aurora, COGeorgetown University, Lombardi Comprehensive Cancer Center· Washington D.C., DCMayo Clinic Rochester· Rochester, MNNYU-Laura & Isaac Perlmutter Cancer Center· New York, NYVanderbilt-Ingram Cancer Center· Nashville, TN

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