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BRIEF TITLE: SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor

SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor


  • Org Study ID: CO-338-098
  • Secondary ID:
  • NCT ID: NCT03992131
  • NCT Alias:
  • Sponsor: Clovis Oncology, Inc. - Industry
  • Source: Clovis Oncology, Inc.

Brief Summary

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

Overal Status Start Date Phase Study Type
Recruiting June 28, 2019 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Primary Outcome 1 - Time Frame: First dose of study drug through at least 28 days after end of treatment.

Primary Outcome 2 - Measure: Number of participants who experience dose limiting toxicity as defined in the protocol. (Phase 1b)

Primary Outcome 2 - Time Frame: Up to 2 years

Primary Outcome 3 - Measure: Overall Response Rate (Phase 2)

Primary Outcome 3 - Time Frame: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years.

Condition:

  • Ovarian Cancer
  • Triple-negative Breast Cancer
  • Urothelial Carcinoma
  • Solid Tumor

Eligibility

Criteria:
Inclusion Criteria Phase 1b (all arms):

- Solid tumor, advanced or metastatic, progressed on standard treatment Patients in Arm
B must have either triple negative breast cancer OR urothelial carcinoma OR ovarian
cancer OR have a solid tumor with a deleterious mutation in BRCA1, BRCA2, PALB2,
RAD51C or RAD51D

- Measurable disease per RECIST v1.1

- Adequate organ function

- ECOG 0 or 1

- Tumor tissue for genomic analysis

Exclusion Criteria Phase 1b (all arms):

- Known history of MDS

- Symptomatic and/or untreated CNS metastases

Inclusion Criteria Phase 2 (all arms):

- Histologically or cytologically confirmed solid tumor, previously treated and
measurable per RECIST v1.1, as follows:

- Arm A: ovarian cancer with gBRCAwt disease, either platinum-sensitive OR
platinum-resistant

- Arm B: Metastatic triple negative breast cancer OR advanced/ metastatic urothelial
carcinoma OR relapsed ovarian cancer

- At least 1 prior line of standard therapy for advanced disease

- Adequate organ function

- ECOG 0 or 1

- Tumor tissue for genomic analysis

Exclusion Criteria Phase 2 (all arms):

- Prior PARPi treatment allowed for patients with ovarian cancer

- Known history of MDS

- Symptomatic and/or untreated CNS metastases
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Name: Clovis Oncology Clinical Trial Navigation

Phone: 1-855-262-3040 (USA)

Email: clovistrials@emergingmed.com

Locations

Facility Status Contact
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting Geoffrey Shapiro, MD, PhD

Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Erika Hamilton, MD

MD Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Timothy Yap, MBBS, Ph.D