Continuation Study of Olaparib in Patients with BRCA-Mutated Ovarian, Metastatic Breast, Pancreatic, Prostate, and Endometrial Cancers

The primary objective of this study is to provide continuous treatment with **olaparib** to patients who have completed a previous oncology study and are deemed by the investigator to clinically benefit from continued treatment. This objective is clinically relevant as it aims to maintain therapeutic benefits in patients with conditions such as BRCA mutated ovarian cancer, epithelial ovarian cancer, metastatic breast cancer, platinum-sensitive relapsed ovarian cancer, gBRCA mutated metastatic pancreatic cancer, prostate cancer, and endometrium cancer. The study will also monitor the safety and tolerability of ongoing treatment with olaparib, ensuring that patients continue to receive a favorable risk-benefit profile.

The clinical trial involves a total of **94 participants** who are patients with various conditions, including **BRCA Mutated Ovarian Cancer**, epithelial ovarian cancer, metastatic breast cancer, platinum-sensitive relapsed ovarian cancer, gBRCA mutated metastatic pancreatic cancer, prostate cancer, and endometrium cancer. The study population comprises both male and female subjects, with age categories ranging from adults to older adults. Participants were selected based on their current clinical benefit from continued treatment in a prior AstraZeneca study involving the compound olaparib. The trial includes a vulnerable population, indicating that special considerations are in place to ensure their safety and well-being. Lifestyle factors such as diet, physical activity, and habits are not specified in the available data. The selection criteria emphasize the continuation of clinical benefit from previous treatments, ensuring that participants are those who have shown positive responses to the investigational compound.

The clinical trial is designed to provide continuous treatment with **olaparib** to patients who have completed a previous oncology study and are deemed by the investigator to benefit from continued treatment. The trial is a phase 3B, randomized, double-blind, controlled study, with an estimated end date of December 30, 2030. The trial aims to monitor the safety and tolerability of the treatment while ensuring that patients continue to receive clinical benefits. Participants will be administered **olaparib** in the form of film-coated tablets, with a maximum daily dose of 600 mg, for a treatment period of up to 123 days.

The sequence of study visits includes an initial inclusion (screening) visit, where eligibility is confirmed based on the principal inclusion criteria, such as the provision of signed informed consent and ongoing clinical benefit from a prior study. Follow-up visits will be scheduled to monitor the safety and efficacy of the treatment, with the primary endpoint being the reporting of serious adverse events (SAEs) and adverse events of special interest (AESIs) up to 30 days after the last dose. The end-of-study visit will conclude the participant's involvement, assessing the overall outcomes and any long-term effects of the treatment.

Participant involvement is expected to last for the duration of the treatment period, with conditions for early termination including the occurrence of significant adverse events or a determination by the investigator that the participant is no longer deriving clinical benefit. The trial is not categorized as low intervention, and it includes patients with various conditions such as BRCA mutated ovarian cancer, metastatic breast cancer, and prostate cancer, among others. The trial's main objective is to ensure that patients who have benefited from **olaparib** in previous studies continue to receive treatment while maintaining a focus on safety and tolerability.

The clinical trial involves the administration of **Lynparza** (Olaparib) in two different dosages: 100 mg and 150 mg film-coated tablets. **Lynparza** is a pharmaceutical product developed by AstraZeneca AB, with the active substance being **olaparib**, a chemical compound. The tablets are administered orally, and the maximum daily dose for both formulations is 600 mg. The treatment period is capped at 123 days. The tablets used in the trial are identical to the commercially available product, except for the absence of commercial debossing or marking, and are provided in an HDPE bottle to maintain blinding in placebo-controlled studies.

The 100 mg film-coated tablet formulation of **Lynparza** is designed for oral administration. Each tablet contains 100 mg of the active ingredient **olaparib**. The maximum allowable daily dose is 600 mg, which can be achieved by administering up to six tablets per day, depending on the patient's treatment plan and clinical judgment. The tablets are provided in a form that facilitates blinding, ensuring that the study's integrity is maintained.

The 150 mg film-coated tablet formulation of **Lynparza** is also intended for oral administration. Each tablet contains 150 mg of **olaparib**. Similar to the 100 mg formulation, the maximum daily dose is 600 mg, which can be achieved by administering up to four tablets per day. The tablets are provided in an unmarked HDPE bottle to support blinding in the study. The administration schedule and dosage adjustments are determined based on the patient's response and tolerability, as assessed by the investigator.

No non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatments, are specified in this trial. The focus is on providing continuous treatment with **Lynparza** to patients who have completed a previous oncology study and are deemed to benefit clinically from continued treatment. Participant compliance is monitored through regular assessments and adherence checks conducted by the study team.

Efficacy in this clinical trial will be assessed primarily through the monitoring of **serious adverse events (SAEs)** and adverse events of special interest (AESIs) reported until 30 days after the last dose of the study drug. The trial is designed to provide continuous treatment with **olaparib** to patients who have completed a previous oncology study and are deemed by the investigator to benefit clinically from continued treatment. The primary endpoint focuses on safety and tolerability, ensuring that patients continue to derive clinical benefit from the treatment. The trial will monitor these parameters throughout the study duration, which is estimated to conclude by December 30, 2030. The study involves the administration of **Lynparza** in the form of 100 mg and 150 mg film-coated tablets, with a maximum daily dose of 600 mg. The trial is categorized as a phase 3B study, aiming to extend treatment benefits while maintaining rigorous safety assessments.