Approval Probability
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rucaparib · 2 trials · 4 indications
Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
The primary efficacy endpoint of PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST (Response Evaluation Criteria in Solid Tumors), as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
| Arm | Type | Description |
|---|---|---|
| Rucaparib | EXPERIMENTAL | Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole. |
| Placebo | PLACEBO_COMPARATOR | Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole. |
| Ovarian cancer | EXPERIMENTAL | rucaparib |
| Name | Type | Description |
|---|---|---|
| Rucaparib | DRUG | Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole. |
| Placebo | DRUG | Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole. |
| Oral rucaparib | DRUG | 600 mg BID |
Inclusion Criteria: * Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer. * Received ≥2 prior platinum-based treatment regimens including platinum based regimen that must have been administered immediately prior to maintenance t...
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Rucaparib is an investigational small molecule being studied for the treatment of ovarian cancer, specifically in patients with platinum-sensitive, relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. It is also being evaluated as a switch maintenance therapy after platinum in relapsed high-grade serous or endometrioid ovarian cancer.
Rucaparib is a small molecule that targets PARP enzymes, which are involved in DNA repair. By inhibiting PARP, rucaparib may interfere with the repair of DNA damage in cancer cells, potentially leading to cell death. This mechanism is being studied in biomarker-selected ovarian cancer patients.
Rucaparib is being developed by Myriad Genetics, Inc., a company traded on the NASDAQ under the ticker symbol MYGN. Myriad Genetics is conducting clinical trials to evaluate the safety and efficacy of rucaparib in ovarian cancer.
Rucaparib is in Phase 3 clinical development for ovarian cancer. It has completed two trials, including a Phase 2 study and a Phase 3 study, with a total enrollment of 1,055 patients. Rucaparib is investigational and has not been approved by regulatory authorities.
Rucaparib has been studied in two completed clinical trials. The Phase 2 trial, NCT01891344 (ARIEL2), enrolled 491 patients with platinum-sensitive, relapsed ovarian cancer. The Phase 3 trial, NCT01968213 (ARIEL3), enrolled 564 patients as switch maintenance after platinum in relapsed high-grade serous or endometrioid ovarian cancer.
Rucaparib is not known by any alternative names. It is a distinct investigational compound developed by Myriad Genetics. No other names for rucaparib have been reported in the clinical trial data.