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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
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Immunomedics, Inc.
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Study Description
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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 Design
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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

Arms and Interventions
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Arm Intervention/treatment
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:
  • Rubraca
  • CO-338

Drug: Lucitanib
Oral lucitanib will be administered once daily
Other Name: CO-3810
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:
  • Rubraca
  • CO-338

Drug: Sacituzumab govitecan
IV Sacituzumab govitecan will be administered Days 1 and 8 every 21 days
Other Name: IMMU-132


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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.

  3. 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 :
  1. 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. ]
  2. 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. ]
  3. 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.

  4. 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)

  5. Cmax - max concentration [ Time Frame: First dose of study drug through at least 28 days after end of treatment ]
    PK Rucaparib (Phase 1b)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)


Eligibility Criteria
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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
Contacts and Locations
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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
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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
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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.
More Information
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Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03992131    
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

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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
Neoplasms
Neoplasms by Site
Breast Neoplasms
Breast Diseases
Skin Diseases
 Rucaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents