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Tyrosine Kinase Inhibitor

Rucaparib for Ovarian Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by ppharmaand GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG 0 or 1
Tumor tissue for genomic analysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of study drug until the date of documented response to treatment, assessed up to 2 years
Awards & highlights

Study Summary

This study is evaluating whether a drug called rucaparib can be safely combined with other drugs to treat cancer.

Eligible Conditions
  • Ovarian Cancer
  • Breast Cancer
  • Bladder Cancer
  • Solid Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose of study drug until the date of documented response to treatment, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study drug until the date of documented response to treatment, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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)
Secondary outcome measures
Duration of Response (DOR) (Phase 2)
Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b)
Progression-free Survival (PFS) (Phase 2)

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213
76%
Nausea
70%
Combined Asthenia/Fatigue
52%
Fatigue
39%
Combined Anaemia and/or decreased hemoglobin
38%
Constipation
38%
Vomiting
37%
Anaemia
35%
Diarrhoea
35%
Alanine aminotransferase increased
34%
Combined ALT/AST increased
33%
Abdominal pain
31%
Dysgeusia
29%
Combined Thrombocytopenia and/or decreased platelets
27%
Aspartate aminotransferase increased
25%
Decreased appetite
23%
Asthenia
22%
Arthralgia
20%
Headache
19%
Combined Neutropenia and/or decreased ANC
19%
Photosensitivity reaction
18%
Cough
17%
Thrombocytopenia
17%
Blood creatinine increased
16%
Dyspepsia
16%
Insomnia
16%
Dizziness
15%
Rash
15%
Pruritus
15%
Dyspnoea
15%
Abdominal pain upper
15%
Back pain
15%
Pyrexia
14%
Platelet count decreased
14%
Neutropenia
13%
Abdominal distension
13%
Upper respiratory tract infection
12%
Hypertension
12%
Oedema peripheral
12%
Hypomagnesaemia
10%
Nasopharyngitis
10%
Alopecia
10%
Taste disorder
10%
Dry skin
10%
Urinary tract infection
9%
Mucosal inflammation
9%
Influenza
9%
Depression
9%
Stomatitis
9%
Erythema
8%
Neutrophil count decreased
8%
Anxiety
8%
Hypercholesterolaemia
8%
Dry mouth
8%
Weight decreased
7%
Myalgia
7%
Oropharyngeal pain
7%
White blood cell count decreased
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Hot flush
6%
Neck pain
6%
Pain in extremity
6%
Blood alkaline phosphatase increased
5%
Muscle spasms
5%
Sinusitis
5%
Combined Anemia and/or low hemoglobin
1%
General physical health deterioration
1%
Incarcerated hernia
1%
Intestinal obstruction
1%
Sepsis
1%
Muscular weakness
1%
Combined Thrombocytopenia and/or low platelets
1%
Osteoarthritis
1%
Gastrointestinal pain
1%
Pulmonary embolism
1%
Febrile neutropenia
1%
Pancytopenia
1%
Small intestinal obstruction
1%
Dehydration
1%
Combined Netropenia and/or low ANC
1%
Malignant melanoma
1%
Malignant neoplasm progression
1%
Myelodysplastic syndrome
1%
Seizure
1%
Acute kidney injury
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rucaparib 600 mg Tablets
Placebo Tablets

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm B: Rucaparib QD and Sacituzumab GovitecanExperimental Treatment2 Interventions
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.
Group II: Arm B: Rucaparib BID and Sacituzumab GovitecanExperimental Treatment2 Interventions
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.
Group III: Arm A: Rucaparib and LucitanibExperimental Treatment2 Interventions
Participants will receive oral rucaparib twice daily (BID) and oral lucitanib once daily (QD) continuously in 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rucaparib
FDA approved
Lucitanib
Not yet FDA approved
Sacituzumab govitecan
FDA approved

Find a Location

Who is running the clinical trial?

ppharmaand GmbHLead Sponsor
11 Previous Clinical Trials
1,739 Total Patients Enrolled
1 Trials studying Ovarian Cancer
34 Patients Enrolled for Ovarian Cancer
pharmaand GmbHLead Sponsor
21 Previous Clinical Trials
4,150 Total Patients Enrolled
5 Trials studying Ovarian Cancer
1,574 Patients Enrolled for Ovarian Cancer
Clovis Oncology, Inc.Lead Sponsor
63 Previous Clinical Trials
10,146 Total Patients Enrolled
7 Trials studying Ovarian Cancer
1,837 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~4 spots leftby Mar 2025