Ovarian CancerPhase 1/2NCT03992131

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

A Phase 1/2 study testing Rucaparib, Lucitanib and Sacituzumab govitecan in people with Ovarian Cancer and Triple-negative Breast Cancer, run by pharmaand GmbH at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ovarian Cancer, Triple-negative Breast Cancer, Urothelial Carcinoma
What is being tested?: Rucaparib, Lucitanib and Sacituzumab govitecan
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 3 sitesUnited States
Study dates: 28 Jun 2019to 22 Apr 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
Histologically or cytologically confirmed solid tumor, previously treated and measurable per RECIST v1.1, as follows:

Show all 12Show fewer

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Dana Farber Cancer Institute
Boston, Massachusetts, 02215
MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203

Other trials in United States

About this study

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

Conditions: Ovarian Cancer, Triple-negative Breast Cancer, Urothelial Carcinoma, Solid Tumor
Being tested: Rucaparib, Lucitanib, Sacituzumab govitecan
Medical subject headings: Ovarian Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RucaparibDrug
Also called Rubraca, CO-338
Rucaparib will be administered per schedule specified in the arm description.
LucitanibDrug
Also called CO-3810
Lucitanib will be administered per schedule specified in the arm description.
Sacituzumab govitecanDrug
Also called IMMU-132
Sacituzumab govitecan will be administered per schedule specified in the arm description.

Study groups in NCT03992131
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Rucaparib; Drug: Sacituzumab govitecan

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 201922 Apr 2022

First posted20 Jun 2019
Study start28 Jun 2019
Primary completion8 Mar 2022
Study completion22 Apr 2022

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ovarian CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03992131
Sponsor's protocol ID: CO-338-098
Other IDs: 2018-003759-39, 2018
Status last verified: Jan 2024
First submitted: 4 Jun 2019
Last updated: 16 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
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RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
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RecruitingObservational study
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All Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03992131
Acronym / sponsor ID: CO-338-098
Conditions: Ovarian Cancer, Triple-negative Breast Cancer, Urothelial Carcinoma, Solid Tumor
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 25 participants (actual)
Lead sponsor: pharmaand GmbHIndustry (pharma, biotech, devices)
Collaborators: Gilead Sciences
Study start: 28 Jun 2019 (actual)
Primary completion: 8 Mar 2022 (actual)
Study completion: 22 Apr 2022 (actual)
First posted: 20 Jun 2019 (actual)
Results: Posted 16 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm A: Rucaparib and Lucitanib	Experimental	Drug: Rucaparib, Drug: LucitanibParticipants will receive oral rucaparib twice daily (BID) and oral lucitanib once daily (QD) continuously in 28-day cycles.
Arm B: Rucaparib BID and Sacituzumab Govitecan	Experimental	Drug: Rucaparib, Drug: Sacituzumab govitecanParticipants 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.
Arm B: Rucaparib QD and Sacituzumab Govitecan	Experimental	Drug: Rucaparib, Drug: Sacituzumab govitecanParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RucaparibAlso: Rubraca, CO-338Rucaparib will be administered per schedule specified in the arm description.	Drug	Arm A: Rucaparib and Lucitanib, Arm B: Rucaparib BID and Sacituzumab Govitecan, Arm B: Rucaparib QD and Sacituzumab Govitecan
LucitanibAlso: CO-3810Lucitanib will be administered per schedule specified in the arm description.	Drug	Arm A: Rucaparib and Lucitanib
Sacituzumab govitecanAlso: IMMU-132Sacituzumab govitecan will be administered per schedule specified in the arm description.	Drug	Arm B: Rucaparib BID and Sacituzumab Govitecan, Arm B: Rucaparib QD and Sacituzumab Govitecan

Primary outcome

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.

3 secondary outcomes

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
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
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

Results and safety

Results posted to the registry on 16 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD	6	6
Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD	4	4
Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD	3	3
Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD	6	6
Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan	3	3
Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan	3	3

Primary outcome: 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

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study drug up to 2 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD	3 of 6 (50%)	6 of 6 (100%)	0 of 6
Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD	2 of 6 (33.3%)	6 of 6 (100%)	0 of 6
Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3

Limitations and caveats (from the sponsor): The study was terminated due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ovarian Cancer

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Epithelial Ovarian Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rucaparib, Lucitanib and Sacituzumab govitecan in people with Ovarian Cancer and Triple-negative Breast Cancer, run by pharmaand GmbH at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03992131.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.