At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
CX-4945drug
Likely dose
CX-4945 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Multi-Center, Open-Label, Treatment Duration Increment, Expansion, Safety, and Pharmacodynamic Study of CX-4945 Administered Orally Twice Daily to Patients With Advanced Basal Cell Carcinoma
In Brief
A Phase 1 clinical trial evaluating CX-4945 for Carcinoma, Basal Cell. Completed, enrolled 25 participants across 6 sites.
Detailed Summary
This study is to determine the recommended phase II dose (RP2D) and schedule of CX-4945 when administered orally twice daily for 28 consecutive days, in a 4-week (28 days) cycle, in patients with locally advanced or metastatic basal cell carcinoma (BCC). The safety and tolerability of CX-4945, preliminary evidence of antitumor effect, and the effect of CX-4945 treatment on the Hh signaling pathway will also be evaluated in this study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Basal Cell
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 2019
Enrollment StartApr 2019
Primary CompletionJan 2024
TodayJul 2026
First PostedApr 1, 2019
Enrollment StartApr 16, 2019
Primary CompletionJan 25, 2024
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.3 years ago
Interventions
CX-4945drug
API powder-in-capsule in 200 mg strength