Trial record 1 of 5 for:
seastar
A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor (SEASTAR)
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| ClinicalTrials.gov Identifier: NCT03992131 |
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Recruitment Status :
Recruiting
First Posted : June 20, 2019
Last Update Posted : August 26, 2019
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Sponsor:
Clovis Oncology, Inc.
Collaborator:
Immunomedics, Inc.
Information provided by (Responsible Party):
Clovis Oncology, Inc.
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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).
| 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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 329 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 |
| Estimated Primary Completion Date : | October 2023 |
| Estimated Study Completion Date : | March 2024 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Rucaparib
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A: Oral rucaparib and oral lucitanib
Phase 1b (Dose escalation): Up to 55 patients with advanced or metastatic solid tumors. Phase 2 (Dose expansion): Up to 80 patients with High Grade Ovarian Cancer. |
Drug: Rucaparib
Oral rucaparib will be administered twice daily
Other Names:
Drug: Lucitanib Oral lucitanib will be administered once daily
Other Name: CO-3810 |
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Experimental: Arm B: Oral rucaparib and IV sacituzumab govitecan
Phase 1b (Dose escalation): Up to 55 patients with metastatic Triple Negative Breast Cancer, metastatic Urothelial Cancer, platinum resistant Ovarian Cancer, or a tumor with a BRCA1, BRCA2, PALB2, RAD51C, or RAD5/1D mutation Phase 2 (Dose expansion): Up to 139 patients with metastatic Triple Negative Breast Cancer, metastatic Urothelial Cancer, or platinum resistant Ovarian Cancer |
Drug: Rucaparib
Oral rucaparib will be administered twice daily
Other Names:
Drug: Sacituzumab govitecan IV Sacituzumab govitecan will be administered Days 1 and 8 every 21 days
Other Name: IMMU-132 |
Primary Outcome Measures :
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: First dose of study drug through at least 28 days after end of treatment. ]Number of participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by CTCAE v5.0 as a measure of safety and tolerability (Phase 1b)
- Number of participants who experience dose limiting toxicity as defined in the protocol. (Phase 1b) [ Time Frame: Up to 2 years ]The highest dose level at which less than 2 of 6 participants or less than 33% of participants experience a dose limiting toxicity will be considered the maximum tolerated dose / recommended phase 2 dose.
- Overall Response Rate (Phase 2) [ Time Frame: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years. ]Preliminary overall response rate (ORR) defined as the proportion of patients with a best overall response of CR or PR according to RECIST 1.1 (Phase 1b)
Secondary Outcome Measures :
- Duration of Response (Phase 2) [ Time Frame: DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first, assessed up to 2 years. ]
- Progression-free survival (PFS) [ Time Frame: PFS defined as 1+ the number of days from the first dose of study drug to documented radiographic progression or death, assessed up to 2 years. ]
- Objective Response (Phase 1b) [ Time Frame: From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years ]Evaluation of individual responses to study treatment according to RECIST 1.1.
- Concentration AUC - area under curve from time zero to time t or infinity [ Time Frame: First dose of study drug through at least 28 days after end of treatment ]PK Rucaparib (Phase 1b)
- Cmax - max concentration [ Time Frame: First dose of study drug through at least 28 days after end of treatment ]PK Rucaparib (Phase 1b)
- Tmax - time to max concentration [ Time Frame: First dose of study drug through at least 28 days after end of treatment ]PK Rucaparib (Phase 1b)
- T1/2 - elimination half-life [ Time Frame: First dose of study drug through at least 28 days after end of treatment ]PK Rucaparib (Phase 1b)
- k el - elimination rate constant [ Time Frame: First dose of study drug through at least 28 days after end of treatment ]PK Rucaparib (Phase 1b)
- Vss/F - volume of distribution at steady state after non-intravenous administration; Cl/F - total plasma clearance [ Time Frame: First dose of study drug through at least 28 days after end of treatment ]PK Rucaparib (Phase 1b)
- Cl/F - total plasma clearance [ Time Frame: First dose of study drug through at least 28 days after end of treatment ]PK Rucaparib (Phase 1b)
Information from the National Library of Medicine
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| 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 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
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
Contacts
| Contact: Clovis Oncology Clinical Trial Navigation | 1-855-262-3040 (USA) | clovistrials@emergingmed.com | |
| Contact: Clovis Oncology Clinical Trial Navigation | 1-303-625-5160 (USA) | clovistrials@emergingmed.com |
Locations
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Geoffrey Shapiro, MD, PhD | |
| Principal Investigator: Geoffrey Shapiro | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Erika Hamilton, MD | |
| Principal Investigator: Erika Hamilton | |
| United States, Texas | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Timothy Yap, MBBS, Ph.D | |
| Principal Investigator: Timothy Yap | |
Sponsors and Collaborators
Clovis Oncology, Inc.
Immunomedics, Inc.
| Responsible Party: | Clovis Oncology, Inc. |
| ClinicalTrials.gov Identifier: | NCT03992131 History of Changes |
| Other Study ID Numbers: |
CO-338-098 |
| First Posted: | June 20, 2019 Key Record Dates |
| Last Update Posted: | August 26, 2019 |
| Last Verified: | August 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms Carcinoma, Transitional Cell Neoplasms Neoplasms by Site Breast Neoplasms Breast Diseases Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Rucaparib |
Camptothecin Antineoplastic Agents Immunoconjugates Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Immunologic Factors Physiological Effects of Drugs |