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Olaparib Continuous BD · 1 trial · 1 indication
Progression-free survival was defined as time from randomization until the date of objective disease progression or death, regardless of whether the patient withdrew from randomized therapy or received another anti-cancer therapy prior to progression. Progression was determined by Blinded independent central review (BICR) using Response Evaluation Criteria In Solid Tumours Version (RECIST 1.1). Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. If patients had no evaluable visits or baseline data, the patient was censored at Study Day 1, unless death occurred within 17 weeks i.e., death within 17 weeks was relative to randomization. Here, the study patient population was stratified as follows: Breast cancer susceptible gene mutation (BRCAm) patients; non BRCAm homologous recombination repair gene mutation (HRRm) patients; non HRRm patients.
Progression-free survival was defined as time from randomization until the date of objective disease progression or death, regardless of whether the patient withdrew from randomized therapy or received another anti-cancer therapy prior to progression. Progression was determined by the site Investigator. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment. If patients had no evaluable visits or baseline data, the patient was censored at Study Day 1, unless death occurred within 17 weeks i.e., death within 17 weeks was relative to randomization. Here, the study patient population was stratified as follows: BRCAm patients; non BRCAm HRRm patients; non HRRm patients.
| Arm | Type | Description |
|---|---|---|
| Olaparib monotherapy | ACTIVE_COMPARATOR | All randomized patients will receive Olaparib monotherapy 300 mg twice daily (BD). |
| Olaparib+Ceralasertib | ACTIVE_COMPARATOR | All randomized patients will receive Olaparib 300 mg twice daily+Ceralasertib 160 mg once daily (OD). |
| Olaparib+adavosertib | ACTIVE_COMPARATOR | All randomized patients will receive Olaparib 200 mg BD +adavosertib 150 mg BD. Following the discontinuation of adavosertib+olaparib treatment arm on 18 April 2019, patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd). |
| Name | Type | Description |
|---|---|---|
| Olaparib Continuous (28-Day cycle) 300 mg BD. | DRUG | Two (2) 150 mg olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water (approximately 250 mL). |
| Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle). | DRUG | Patients will be administered Ceralasertib OD at 160 mg from Day 1 to Day 7 (inclusive) of every 28-day cycle. |
| Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle). | DRUG | Patients will be administered adavosertib BD at 150mg from Day 1 to Day 3 and Day 8 to Day 10. |
Pertinent Inclusion criteria: 1. Informed consent prior to any study specific procedures. 2. Male or female ≥18 years of age. 3. Progressive cancer at the time of study entry. 4. Histologically or cytologically confirmed TNBC at initial diagnosis with evidence of metastatic disease and HER2 negativ...
Olaparib Continuous BD is an investigational small molecule being studied for the treatment of metastatic triple negative breast cancer. It is a PARP inhibitor, and the continuous 28-day cycle at 300 mg twice daily is being evaluated in a Phase 2 clinical trial. It is not yet approved and remains in clinical development.
Olaparib Continuous BD targets PARP, a class of enzymes involved in DNA repair. By inhibiting PARP, the drug is designed to interfere with cancer cell repair mechanisms. This mechanism is being investigated in the context of metastatic triple negative breast cancer, where the drug is administered continuously on a 28-day cycle at 300 mg twice daily.
Olaparib Continuous BD is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting a Phase 2 clinical trial to evaluate the drug's safety and efficacy in patients with metastatic triple negative breast cancer.
Olaparib Continuous BD is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting or has completed enrollment, with a total planned enrollment of 273 participants, and is being conducted across multiple countries.
Olaparib Continuous BD is being studied in one active Phase 2 clinical trial with the identifier NCT03330847. The trial, titled 'To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy,' enrolls 273 patients with metastatic triple negative breast cancer. It is an active, non-recruiting study conducted in multiple countries.
Yes, Olaparib Continuous BD is also known as Olaparib Continuous (28-Day cycle) 300 mg BD. Both names refer to the same investigational drug, which is being evaluated in a Phase 2 trial for metastatic triple negative breast cancer. The name specifies the continuous dosing schedule of 300 mg twice daily over a 28-day cycle.