Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003759-39 | EudraCT Number |
Not provided
Not provided
Not provided
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.
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
Not provided
Not provided
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Not provided
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rucaparib | Drug | Rucaparib will be administered per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria Phase 1b (all arms):
Exclusion Criteria Phase 1b (all arms):
Inclusion Criteria Phase 2 (all arms):
Exclusion Criteria Phase 2 (all arms):
Not provided
Not provided
Not provided
Not provided
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Sarah Cannon Research Institute |
The study was planned to be conducted in 2 phases: Phase 1b and Phase 2. Enrollment was terminated before Phase 1b was complete, due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan. Hence, Phase 2 portion of the study was not conducted.
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD | Participants received oral rucaparib 300 milligrams (mg) twice daily (BID) and oral lucitanib 4 mg once daily (QD) continuously in 28-day cycles. |
| FG001 | Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2020 | Aug 23, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Lucitanib | Drug | Lucitanib will be administered per schedule specified in the arm description. |
|
|
| Sacituzumab govitecan | Drug | Sacituzumab govitecan will be administered per schedule specified in the arm description. |
|
|
| 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. | 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. | From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. |
| FG002 | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. |
| FG003 | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. |
| FG004 | Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg BID, administered continuously, in combination with intravenous (IV) sacituzumab govitecan 6 mg/kilogram (kg) administration on Day 1 and Day 8 of a 21-day cycle. |
| FG005 | Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Safety population included all participants who have received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD | Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. |
| BG001 | Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD | Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. |
| BG002 | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. |
| BG003 | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. |
| BG004 | Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. |
| BG005 | Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | 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. | Posted | From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | From the date of first best response to disease progression or death, whichever occurs first, assessed up to 2 years |
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | From the first dose of study drug to documented radiographic progression or death, whichever occurs first, assessed up to 2 years |
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years |
|
From the first dose of study drug up to 2 years
Safety population included all participants who have received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A1: Rucaparib 300 mg BID and Lucitanib 4 mg QD | Participants received oral rucaparib 300 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. | 0 | 6 | 3 | 6 | 6 | 6 |
| EG001 | Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD | Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG002 | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. | 0 | 6 | 2 | 6 | 6 | 6 |
| EG004 | Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. | 0 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Swelling face | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Breast swelling | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Zinc deficiency | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Depression | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
The study was terminated due to Sponsor's decision to discontinue development of the combination of rucaparib and sacituzumab govitecan.
Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Department | pharmaand GmbH | +43/1/3560006 | medinfo@pharmaand.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2021 | Aug 23, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C531549 | rucaparib |
| C000595232 | E-3810 |
| C000608132 | sacituzumab govitecan |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Arm A2: Rucaparib 400 mg BID and Lucitanib 4 mg QD |
Participants received oral rucaparib 400 mg BID and oral lucitanib 4 mg QD continuously in 28-day cycles. |
| OG002 | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. |
| OG003 | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. |
| OG004 | Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. |
| OG005 | Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. |
|
| OG002 | Arm A3: Rucaparib 400 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. |
| OG003 | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. |
| OG004 | Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. |
| OG005 | Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. |
|
Participants received oral rucaparib 400 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. |
| OG003 | Arm A4: Rucaparib 600 mg BID and Lucitanib 6 mg QD | Participants received oral rucaparib 600 mg BID and oral lucitanib 6 mg QD continuously in 28-day cycles. |
| OG004 | Arm B1: Rucaparib 300 mg BID and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg BID, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. |
| OG005 | Arm B2: Rucaparib 300 mg QD and Sacituzumab Govitecan | Participants received oral rucaparib 300 mg QD, administered continuously, in combination with IV sacituzumab govitecan 6 mg/kg administration on Day 1 and Day 8 of a 21-day cycle. |
|
|