Trial · NCT03992131
A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)
NCT03992131, Phase 1, Phase 2, Terminated, pharmaand GmbH; results first posted 2024-01-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR). Trials, record NCT03992131. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03992131
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)
- NCT number
- NCT03992131
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- pharmaand GmbH
- Conditions
- Ovarian Cancer, Triple-negative Breast Cancer, Urothelial Carcinoma, Solid Tumor
- Interventions
- Rucaparib, Lucitanib, Sacituzumab govitecan
- First posted
- 2019-06-20
- Last updated
- 2024-01-16
- Other registries' IDs
- eudract:2018-003759-39
- Results first posted
- 2024-01-16
- Limitations and caveats
- The study was terminated due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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) | 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 | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years | 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. | ||
| SECONDARY | 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 | 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. | ||
| SECONDARY | 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 | 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. | ||
| SECONDARY | 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 | Efficacy population included all participants who had received at least 1 dose of rucaparib or the second study drug and who had measurable disease per RECIST v1.1 at baseline. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b) | Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD | 1 | Participants | ||
| Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b) | Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD | 0 | Participants | ||
| Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b) | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | 0 | Participants | ||
| Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b) | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | 0 | Participants | ||
| Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b) | Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan | 1 | Participants | ||
| Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b) | Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan | 2 | Participants |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD | 6 | |
| Overall Study | STARTED | Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD | 4 | |
| Overall Study | STARTED | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | 3 | |
| Overall Study | STARTED | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | 6 | |
| Overall Study | STARTED | Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan | 3 | |
| Overall Study | STARTED | Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan | 3 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD | 6 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD | 4 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | 3 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | 6 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events816
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | 3 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan | 1 | 3 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD | 1 | 6 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD | 0 | 4 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | 0 | 3 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | 0 | 6 |
1 to 10 of 816Source ClinicalTrials.gov
See all 816 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD | 0 | 6 |
| Total, all-cause mortality | Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD | 0 | 4 |
| Total, all-cause mortality | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | 0 | 3 |
| Total, all-cause mortality | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | 0 | 6 |
| Total, all-cause mortality | Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan | 0 | 3 |
| Total, all-cause mortality | Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan | 0 | 3 |
| Total, other adverse events | Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD | 6 | 6 |
| Total, other adverse events | Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD | 4 | 4 |
| Total, other adverse events | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | 3 | 3 |
| Total, other adverse events | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | 6 | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03992131
GET https://conductscience.org/api/trials/v1/NCT03992131/flow?page=2