G1 Therapeutics Policy for Expanded Access to Investigational Agents
G1 Therapeutics is dedicated to developing medical treatments that address significant unmet needs for people with a diagnosis of cancer. We are currently evaluating our investigational treatments in clinical trials so that we can fully understand how they work, which patients are most likely to benefit and carefully determine safety and efficacy.
Clinical trials result in the generation of evidence that may lead to the approval of a treatment, making it more widely available to patients.
People who have exhausted currently available cancer treatments may seek access to investigational treatments through clinical trials.
However, sometimes a person with cancer is not able to participate in a clinical trial, and a physician may request that the investigational treatment be made available to him or her outside of the trial. G1 is committed to helping people with a diagnosis of cancer who may benefit by accessing our investigational treatments by considering requests in a scientifically and ethically responsible manner.
Healthcare professionals, patients and caregivers who are interested in learning more about G1’s investigational drugs that are currently under investigation can go to clintrials.gov and search using various search criteria (company name, drug name, disease, etc).
The following criteria are used when considering a request:
- The investigational treatment must be in active clinical studies in human subjects. This enables us to comply with local regulations on manufacturing, preclinical safety and reporting obligations, and to ensure that trained personnel are responsible for the safe shipment of the investigational treatment.
- Participants must first be considered for ongoing clinical trials of the investigational treatment.
- The person must have a serious, immediately life‐threatening disease or condition.
- The potential benefits to the person must outweigh the potential risks of the investigational treatment.
- The requesting physician must be qualified, and agree to directly supervise treatment.
- The physician requesting access must provide:
- A scientifically justified rationale for the theoretical benefit of the investigational treatment;
- A statement that approved therapies typically used to treat the disease have been exhausted; and
- A statement that there are no other viable therapy options, including participation in clinical trials.
- There must be sufficient clinical data to identify an appropriate dose (amount and frequency of the investigational treatment given), dosage form and route of administration.
- G1 must have a sufficient supply of the investigational treatment to reasonably accommodate the likely duration of treatment for the expanded access request.
If you are a healthcare professional who would like to request access of a G1 investigational treatment for a patient, please email Patient.Access@Bionical-Emas.com.
All requests will be responded to within 5 business days.
If you are a patient and would like to make a request for access of a G1 investigational treatment, please contact your healthcare professional.
There is no guarantee that the investigational drugs in the study will be approved and will be commercially available.