A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
pharmaand GmbH
Study ID
NCT03992131
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Rucaparib — DRUG
    Rucaparib will be administered per schedule specified in the arm description.
  • Lucitanib — DRUG
    Lucitanib will be administered per schedule specified in the arm description.
  • Sacituzumab govitecan — DRUG
    Sacituzumab govitecan will be administered per schedule specified in the arm description.

Study Details

This is an open label, Phase 1b/2 study with multiple treatment arms evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of rucaparib in combination with a second anticancer therapy in participants with an advanced/metastatic solid malignancy (Phase 1b), followed by evaluation of the combination in one or more specific participant populations in an expansion phase (Phase 2 cohorts).

Key Dates

Start date
Jun 28, 2019
Status verified
Jan 2024
Primary completion
Mar 8, 2022
Completion
Apr 22, 2022

Study Design

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

Arms

  • Experimental: Arm A: Rucaparib and Lucitanib
    Participants will receive oral rucaparib twice daily (BID) and oral lucitanib once daily (QD) continuously in 28-day cycles.
  • Experimental: Arm B: Rucaparib BID and Sacituzumab Govitecan
    Participants will receive oral rucaparib BID, administered continuously, in combination with intravenous (IV) sacituzumab govitecan administration on Day 1 and Day 8 of a 21-day cycle.
  • Experimental: Arm B: Rucaparib QD and Sacituzumab Govitecan
    Participants will receive oral rucaparib QD, administered continuously, in combination with IV sacituzumab govitecan administration on Day 1 and Day 8 of a 21-day cycle.

Primary Outcome Measure

Number of Participants With Objective Response, as Assessed by the Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 (Phase 2) [ Time Frame: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Sarah Cannon Research InstituteNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-

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