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Brief Title: A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR)

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

INTRODUCTION

  • Org Study ID: CO-338-098
  • Secondary ID: N/A
  • NTC ID: NCT03992131
  • Sponsor: 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).


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

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: 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 - Timeframe: Up to 2 years

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

Primary Outcome 3 - Timeframe: 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


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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

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

Email: clovistrials@emergingmed.com

LOCATION

Facility Status Contact
Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States 		Status: Recruiting Contact:
Geoffrey Shapiro, MD, PhD
Facility: Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States 		Status: Recruiting Contact:
Erika Hamilton, MD
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States 		Status: Recruiting Contact:
Timothy Yap, MBBS, Ph.D

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