Venadaparib : Metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy
Eligibility and Evaluation Criteria
We will consider requests for expanded access to Venadaparib only when the following criteria are met:
• The patient has metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy, which is a serious or life-threatening condition.
• There is no comparable or satisfactory alternative therapy available.
• The patient is ineligible for, or cannot participate in, an ongoing clinical trial.
• The potential benefit to the patient justifies the potential risks of the treatment.
• The patient is a candidate for and can tolerate the combination therapy of Venadaparib and Irinotecan as per the physician’s assessment.
• Providing the investigational drug will not interfere with the initiation, conduct, or completion of clinical trials that could support the drug's development or marketing approval.
Request Process and Contact Information
Requests for expanded access must be submitted by a licensed treating physician who is qualified to administer investigational therapy and agrees to comply with all regulatory requirements.
• Submission Channel: clinicaltrials@idience.com
• Required Information: A formal request from the physician including patient medical history (redacted for privacy) and the rationale for the request.
• Drug Supply: Please note that Idience will only provide the investigational drug, Venadaparib (IDX-1197). The treating physician or the medical institution is responsible for procuring and administering the combination drug (Irinotecan).