Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Triple Negative Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma, Transitional Cell

Breast Diseases

Skin Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Transitional Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Sacituzumab govitecan

Rucaparib

Immunoconjugates

Immunologic Factors

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Participants will receive oral rucaparib twice daily (BID) and oral lucitanib once daily (QD) continuously in 28-day cycles.

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.

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.

Rucaparib will be administered per schedule specified in the arm description.

Lucitanib will be administered per schedule specified in the arm description.

Lucitanib

Sacituzumab govitecan will be administered per schedule specified in the arm description.

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).

A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants 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

Objective response was defined as a documented and confirmed best overall response of complete response (CR) or partial response (PR) as assessed by the investigator. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 millimeters (mm); and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Duration of response was measured from the date that best response (CR or PR) was first recorded until the first date that disease progression was documented per RECIST v1.1. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm; and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression.

PFS was measured as the 1+ the number of days from the first dose of study drug to documented radiographic progression, according to RECIST v1.1, as determined by the investigator, or death due to any cause, whichever occurred first. Progressive disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression.

Objective response was defined as a documented and confirmed best overall response of CR or PR as assessed by the investigator. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 mm; and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

Gilead Sciences

pharmaand GmbH

Safety population included all participants who have received at least 1 dose of study drug.

Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.

Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD

Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles.

Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD

Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.

Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD

Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles.

Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD

Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.

Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan

Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle.

Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The study was terminated due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan.

Medical Information Department

Due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan, the study was terminated before Phase 1b was complete, and Phase 2 portion of the study was not conducted. Hence, the data for this outcome measure could not be collected and analyzed.

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)

Duration of Response (DOR) (Phase 2)

Progression-free Survival (PFS) (Phase 2)

Efficacy population included all participants who had received at least 1 dose of rucaparib or the second study drug and who had measurable disease per RECIST v1.1 at baseline.

Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b)

Participants received oral rucaparib 300 milligrams (mg) twice daily (BID) and oral lucitanib 4 mg once daily (QD) continuously in 28-day cycles.

Participants received oral rucaparib 300 mg BID, administered continuously, in combination with intravenous (IV) sacituzumab govitecan 6 mg/kilogram (kg) administration on Day 1 and Day 8 of a 21-day cycle.

Spots Global Cancer Trial Database for A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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