This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03992131
Recruitment Status : Terminated (Due to a change in development priorities, no further clinical development of the lucitanib plus rucaparib or lucitanib plus sacituzumab govitecan combinations is planned at this time.)
First Posted : June 20, 2019
Results First Posted : January 16, 2024
Last Update Posted : January 16, 2024
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
pharmaand GmbH

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Triple-negative Breast Cancer Urothelial Carcinoma Solid Tumor Drug: Rucaparib Drug: Lucitanib Drug: Sacituzumab govitecan Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 28, 2019
Actual Primary Completion Date : March 8, 2022
Actual Study Completion Date : April 22, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Arm A: Rucaparib and Lucitanib
Participants will receive oral rucaparib twice daily (BID) and oral lucitanib once daily (QD) continuously in 28-day cycles.
 Drug: Rucaparib
Rucaparib will be administered per schedule specified in the arm description.
Other Names:
  • Rubraca
  • CO-338

Drug: Lucitanib
Lucitanib will be administered per schedule specified in the arm description.
Other Name: CO-3810
Experimental: Arm B: Rucaparib BID and Sacituzumab Govitecan
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
Rucaparib will be administered per schedule specified in the arm description.
Other Names:
  • Rubraca
  • CO-338

Drug: Sacituzumab govitecan
Sacituzumab govitecan will be administered per schedule specified in the arm description.
Other Name: IMMU-132
Experimental: Arm B: Rucaparib QD and Sacituzumab Govitecan
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
Rucaparib will be administered per schedule specified in the arm description.
Other Names:
  • Rubraca
  • CO-338

Drug: Sacituzumab govitecan
Sacituzumab govitecan will be administered per schedule specified in the arm description.
Other Name: IMMU-132


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary Outcome Measures :
  1. Duration of Response (DOR) (Phase 2) [ Time Frame: From the date of first best response to disease progression or death, whichever occurs first, assessed up to 2 years ]
    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.

  2. Progression-free Survival (PFS) (Phase 2) [ Time Frame: From the first dose of study drug to documented radiographic progression or death, whichever occurs first, assessed up to 2 years ]
    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.

  3. Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b) [ Time Frame: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992131


Locations
Layout table for location information
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
pharmaand GmbH
Gilead Sciences
  Study Documents (Full-Text)

Documents provided by pharmaand GmbH:
Study Protocol  [PDF] September 1, 2020
Statistical Analysis Plan  [PDF] September 10, 2021

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: pharmaand GmbH
ClinicalTrials.gov Identifier: NCT03992131    
Other Study ID Numbers: CO-338-098
2018-003759-39 ( EudraCT Number )
First Posted: June 20, 2019    Key Record Dates
Results First Posted: January 16, 2024
Last Update Posted: January 16, 2024
Last Verified: January 2024

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Triple Negative Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Neoplasms
Breast Diseases
Skin Diseases
Rucaparib
Sacituzumab govitecan
 Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents