A Phase 1b Study of Paclitaxel And Ricolinostat For The Treatment Of Gynecological Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT02661815
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Paclitaxel — DRUG
    Please see arm/group description.
  • Ricolinostat — DRUG
    Please see arm/group description.
  • Bevacizumab — DRUG
    Please see arm/group description.

Study Details

Participants with Ovarian, Fallopian Tube, or Peritoneal Cancer that has recurred within 12 months of prior treatment that includes Platinum Chemotherapy are invited to take part in this study. This research study is studying a combination of a new chemotherapy drug called Ricolinostat together with the chemotherapy Paclitaxel and a drug called Bevacizumab as a possible treatment for this diagnosis.

Key Dates

First listed
Jan 25, 2016
Start date
Jun 15, 2016
Status verified
Nov 2019
Primary completion
Jun 28, 2017
Completion
Jul 28, 2017

Study Design

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

Arms

  • Experimental: Phase 1 Expansion Cohort A
    Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
  • Experimental: Phase 1 Expansion Cohort B
    Paclitaxel 70mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
  • Experimental: Phase 1 Expansion Cohort C
    Paclitaxel 80mg/m2 weekly days 1, 8, and 15 of a 28-day cycle Bevacizumab 10mg/kg days 1 and 15 of a 28-day cycle Ricolinostat dosing as identified as the RP2D combination dose
  • Experimental: Phase 1 Escalation Cohort
    Ricolinostat with weekly paclitaxel dosed at 80 mg/m2 per week (3 out of 4 weeks).

Primary Outcome Measure

Analysis Report on the MTD In The Dose Escalation Portion Of The Study [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massacusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Dana-Farber Cancer Institute· Boston, MAMassacusetts General Hospital· Boston, MA

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