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

NCT03992131 | Terminated Phase 1 Results DMC FDA Drug

• 2 other identifiers: CO-338-0982018-003759-39
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years

Secondary Outcomes (3)

• Duration of Response (DOR) (Phase 2)

  From the date of first best response to disease progression or death, whichever occurs first, assessed up to 2 years

• Progression-free Survival (PFS) (Phase 2)

  From the first dose of study drug to documented radiographic progression or death, whichever occurs first, assessed up to 2 years

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

  From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years

Study Arms (3)

Arm A: Rucaparib and Lucitanib

EXPERIMENTAL

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

Drug: Rucaparib; Drug: Lucitanib

Arm B: Rucaparib BID and Sacituzumab Govitecan

EXPERIMENTAL

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.

Drug: Rucaparib; Drug: Sacituzumab govitecan

Arm B: Rucaparib QD and Sacituzumab Govitecan

EXPERIMENTAL

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.

Drug: Rucaparib; Drug: Sacituzumab govitecan

Interventions

Rucaparib DRUG

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

Also known as: Rubraca, CO-338

Arm A: Rucaparib and Lucitanib; Arm B: Rucaparib BID and Sacituzumab Govitecan; Arm B: Rucaparib QD and Sacituzumab Govitecan

Lucitanib DRUG

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

Also known as: CO-3810

Arm A: Rucaparib and Lucitanib

Sacituzumab govitecan DRUG

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

Also known as: IMMU-132

Arm B: Rucaparib BID and Sacituzumab Govitecan; Arm B: Rucaparib QD and Sacituzumab Govitecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known history of myelodysplastic syndrome (MDS)
• Symptomatic and/or untreated central nervous system (CNS) metastases
• 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
• 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

Sponsors & Collaborators

• pharmaand GmbH: lead
• Gilead Sciences: collaborator

Study Sites (3)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Transitional Cell

Interventions

rucaparib; E-3810; sacituzumab govitecan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Limitations and Caveats

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

Results Point of Contact

• Title: Medical Information Department
• Organization: pharmaand GmbH

medinfo@pharmaand.com

+43/1/3560006

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 20, 2019
• Study Start: June 28, 2019
• Primary Completion: March 8, 2022
• Study Completion: April 22, 2022
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2024-01

Locations

US (3)