Clinical trial NCT03992131: A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Triple-negative Breast Cancer
Urothelial Carcinoma
Solid Tumor
Lead sponsor: pharmaand GmbH
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2019-06-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


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

* Solid tumor, advanced or metastatic, progressed on standard treatment participants 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
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Tumor tissue for genomic analysis

Exclusion Criteria Phase 1b (all arms):

* Known history of myelodysplastic syndrome (MDS)
* Symptomatic and/or untreated central nervous system (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 poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor treatment allowed for participants with ovarian cancer
* Known history of MDS
* Symptomatic and/or untreated CNS metastases

Primary outcomes:
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)
timeFrame: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years
Secondary outcomes:
measure: Duration of Response (DOR) (Phase 2)
timeFrame: From the date of first best response to disease progression or death, whichever occurs first, assessed up to 2 years
measure: Progression-free Survival (PFS) (Phase 2)
timeFrame: From the first dose of study drug to documented radiographic progression or death, whichever occurs first, assessed up to 2 years
measure: Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b)
timeFrame: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: