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
Concept and/or synopsis forms can be requested by email from ISS@g1therapeutics.com. Completed Investigator Sponsored Study (ISS) proposal requests must be submitted to ISS@g1therapeutics.com. Submission of a request does not guarantee approval or support of the proposal. No field representatives may request support on behalf of customers. Submitted ISS requests are reviewed routinely by the G1 Therapeutics ISS Review Committee.
An ISS 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 Investigator Sponsored Study program. Priority will be given to applications proposing to investigate trilaciclib in the following areas of interest:
| Areas Of Interest | |
|---|---|
| Gastrointestinal cancer (esophageal, CRC) | in combination with FOLFOX |
| Pancreatic cancer | in combination with FOLFIRINOX |
| NSCLC | in combination with checkpoint inhibitor use in 1st line |
| Small cell lung cancer | in combination with Lurbinectedin |
| Triple negative breast cancer | in combination with chemotherapy and checkpoint inhibitor in 1st line or 2nd line |
| Ovarian cancer | in combination with Carboplatin/Paclitaxel in 1st line |
| Sarcoma | in combination with Doxorubicin + Cisplatin or ifosfamide |
| Other areas | myelopreservation and or anti-tumor effects not currently under investigation by G1 Therapeutics |
| Observational studies | SCLC patient-reported outcomes and healthcare resource utilization |
Following areas of interest are out of scope and not supported:
- Hematological malignancies
- Studies duplicative of current G1 development program
Considerations for the investigator: Limited funds may be available to support proposals