US company conducts a clinical trial of First-in-Human Evaluation of GRN-300 in Subjects With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers
Green3Bio, Inc is recruiting patients for the clinical trial of First-in-Human Evaluation of GRN-300 in Subjects With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers.
December 21, 2020 is the study start date. The indicative completion of the clinical trial will be expected in March 2023.
Overall duration of the study will be approximately 24 months, depending on the rate of enrollment and number of subjects enrolled.
The study will take place at the MD Anderson Cancer Center, Houston, Texas, United States.
There are a number of conditions that do not allow participation, such as:
- Patients with known hypersensitivity to paclitaxel or residual Grade 2 or higher neuropathy (excluded from Phase IB portion only).
- Use of any cytotoxic chemotherapy or investigational drugs, biologics, or devices within 21 days prior to study enrollment.
- Women who are pregnant or breastfeeding.
- Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
- Known CNS metastases or leptomeningeal disease.
- Gastrointestinal dysfunction that may affect oral drug absorption (e.g., intermittent or chronic bowel obstruction, short gut, etc.).
- Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within six months of start of study treatment.
- Other medical co-morbidities that in the investigator's judgment would increase the risks of participation.
- QTc >480 msec be excluded from the study.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04711161
