Metastatic Castrate Resistant Prostate Cancer (mCRPC) Clinical Trial
Official title:
A Phase 1/2, Multi-Center, Open-Label, Two-Stage Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GT0918 in Subjects With Metastatic Castrate Resistant Prostate Cancer (mCRPC)
This was a Phase 1, multicenter, open-label, clinical trial in adult subjects with metastatic
castrate resistant prostate cancer who progressed after both hormonal therapy (abiraterone or
enzalutamide) and chemotherapy (docetaxel), or cannot tolerate either or both therapies.
The study involved a Phase 1 dose escalation of oral GT0918 to evaluate its safety,
tolerability, pharmacokinetics and pharmacodynamics.
GT0918 treatment was initiated with the first dose of 50 mg/day in a cohort of 3 patients,
and 6- patients per cohort for the subsequent escalated dose levels at 100 mg, 200 mg, 300
mg, 400 mg, 500 mg and 600 mg/day. Patients received orally administered GT0918 once daily at
the indicated doses for 28 consecutive days (4 weeks), followed by a 7-day off-treatment
period for PK analysis. This concluded the Cycle 1 treatment. Patients who could not complete
the first cycle of 28 days for DLT evaluation were to be considered as early termination and
replaced. Upon completion of the Cycle 1 treatment, if no DLT occurred in the cohort of 3
patients, or no more than 1 patient had DLT in cohorts with at least 6 patients, dose
escalation was allowed for the subsequent higher dose.
Patients were to receive up to 6 cycles of GT0918 treatments at their assigned dose levels if
they were evaluated by the investigator to have no unacceptable toxicity and show evidence of
clinical benefit (stable disease or a response) per RECIST v1.1 criteria and PSA assessments.
No off-treatment periods were scheduled for the additional cycles from Cycle 2 beyond.
Patients had to be evaluated bi-monthly for their eligibility to continue the treatment of
additional cycles. Patient evaluations included CT and/or MRI scans performed every 2 cycles
(8 weeks), as well as physical examinations, ECOG performance status, PSA measurements, which
were performed every 4 weeks. Cycles beyond the 6th cycle were optional for eligible subjects
that did not exhibit progressive disease (PD). Eligible patients could be treated for a total
of 6 months at their assigned dose level at the investigator's discretion.
Patients would have an End-of-Study (EOS) visit if treatment were discontinued due to
intolerable toxicities, disease progression, withdrawal of consent. Safety follow-up for
possible delayed drug-related AE or side effects can be performed by phone call or office
visit if needed.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04597125 -
Investigation of Radium-223 Dichloride (Xofigo), a Treatment That Gives Off Radiation That Helps Kill Cancer Cells, Compared to a Treatment That Inactivates Hormones (New Antihormonal Therapy, NAH) in Patients With Prostate Cancer That Has Spread to the Bone Getting Worse on or After Earlier NAH
|
Phase 4 | |
| Completed |
NCT03899467 -
The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC
|
Phase 2 |