Investigator Sponsored Studies

Investigator Sponsored Study (ISS) and ISS Sponsor

An ISS is a study that is developed and conducted by a qualified sponsor external to G1 Therapeutics who assumes full responsibility for the conduct of the study. An ISS can take a variety of forms including clinical and nonclinical studies that may be interventional or observational.

G1 Therapeutics supports investigator sponsored studies that align with G1 Therapeutics areas of scientific interest. A summary of the areas of interest can be found by clicking on the link below.

ISS Request Process

Proposal forms can be requested by email from ISS@g1therapeutics.com. Completed proposals proposal requests must be submitted to ISS@g1therapeutics.com. Field representatives may not request support on behalf of customers. Submitted ISS proposals are reviewed routinely by the G1 Therapeutics ISS Review Committee.

Submission of a proposal requesting G1 Therapeutics support (e.g., funding and/or drug supply) is not a guarantee of acceptance or approval of that proposal. A formal notification regarding the status of your application will be communicated once a decision is reached. For any questions, please send email to ISS@g1therapeutics.com.

Areas of Scientific Interest

Trilaciclib is available through the ISS program. Priority will be given to applications proposing to investigate trilaciclib in the following areas of interest:

  1. Pre-Clinical/Translational and Clinical studies investigating myeloprotection and/or anti-tumor effects of trilaciclib in the following:
    1. Gastrointestinal cancer
    2. Non-small cell lung cancer
    3. Breast cancer
    4. Ovarian cancer
    5. Genitourinary cancer
    6. Sarcomas
    7. Highly immunogenic tumors
    8. Other tumor types not currently under investigations by G1 Therapeutics
  2. Observational studies: SCLC patient-reported outcomes and healthcare resource utilization
  3. Myeloprotection

 

The following areas of interest are out of scope and not supported:

  • Hematological malignancies
  • Studies that compete with ongoing G1 Therapeutics studies


Considerations for the investigator:  Limited funds may be available to support proposals.  Studies must commence within 1 calendar year of draft protocol approval.