Study of CX-4945 in Combination With Gemcitabine and Cisplatin for Frontline Treatment of Cholangiocarcinoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Senhwa Biosciences, Inc.
Study ID
NCT02128282
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Cholangiocarcinoma

Eligibility Criteria

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

Interventions

  • CX-4945 — DRUG
    API powder-in-capsule in 200 mg strength.
  • Cisplatin — DRUG
    25 mg/m.sq. administered by IV infusion on Days 1 and 8 of a 21-day cycle.
  • Gemcitabine — DRUG
    1,000 mg/m.sq. administered by IV infusion on Days 1 and 8 of a 21-day cycle.

Study Details

This study considers the safety and tolerability of increasing doses of CX-4945 in combination with gemcitabine plus cisplatin to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D), followed by a randomized study that compares antitumor activity in cholangiocarcinoma patients receiving the standard of care gemcitabine plus cisplatin versus CX-4945 at the combination RP2D with gemcitabine plus cisplatin.

Key Dates

Start date
Jun 30, 2014
Status verified
Oct 2021
Primary completion
Nov 6, 2020
Completion
Aug 5, 2021

Study Design

Enrollment
127 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Escalation CX-4945 plus Cis/Gem
    CX-4945 capsules at the combination MTD on Days 0, 1 and 2, and Days 7, 8 and 9. PLUS Cisplatin 25 mg/m.sq. by IV infusion on Days 1 and 8. PLUS Gemcitabine 1,000 mg/m.sq. by IV infusion on Days 1 and 8. On a 21-day cycle.
  • Active Comparator: Cisplatin plus Gemcitabine
    Cisplatin 25 mg/m.sq. by IV infusion on Days 1 and 8. PLUS Gemcitabine 1,000 mg/m.sq. by IV infusion on Days 1 and 8. On a 21-day cycle.
  • Experimental: 10-day CX-4945 plus Cis/Gem
    CX-4945 capsules at 1000mg/BID, 10-day continuous dosing (Day 0 through Day 9). PLUS Cisplatin 25 mg/m.sq. by IV infusion on Days 1 and 8. PLUS Gemcitabine 1,000 mg/m.sq. by IV infusion on Days 1 and 8. On a 21-day cycle.
  • Experimental: 21-day CX-4945 plus Cis/Gem
    CX-4945 capsules at 1000mg/BID, 21-day continuous dosing PLUS Cisplatin 25 mg/m.sq. by IV infusion on Days 1 and 8. PLUS Gemcitabine 1,000 mg/m.sq. by IV infusion on Days 1 and 8. On a 21-day cycle.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of CX-4945 when used in combination with gemcitabine plus cisplatin. (Phase 1) [ Time Frame: Cycle 1, 1 Full cycle up to twenty-one (21) days ]

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259-5499-
University of Colorado- DenverAuroraColorado80045-
Mayo ClinicJacksonvilleFlorida32224-
Mayo ClinicRochesterMinnesota55905-
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
Texas Oncology-TylerTylerTexas75702-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic· Scottsdale, AZUniversity of Colorado- Denver· Aurora, COMayo Clinic· Jacksonville, FLMayo Clinic· Rochester, MNTexas Oncology - Baylor Charles A. Sammons Cancer Center· Dallas, TXTexas Oncology-Tyler· Tyler, TX

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