Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Senhwa Biosciences, Inc.
- Study ID
- NCT03897036
- Phase
- PHASE1
- Status
- Completed
Conditions
- Carcinoma, Basal Cell
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CX-4945 — DRUGAPI powder-in-capsule in 200 mg strength
Study Details
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.
Key Dates
- Start date
- Apr 16, 2019
- Status verified
- May 2025
- Primary completion
- Jan 25, 2024
- Completion
- Jan 25, 2024
Study Design
- Enrollment
- 25 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment-Duration-IncrementCX-4945 capsules at 1000mg BID x 28 days/cycle
- Experimental: ExpansionCX-4945 capsules at 1000mg BID x 28 days/cycle
Primary Outcome Measure
Determination of RP2D [ Time Frame: Cycle 1, twenty-eight (28) day continuous dosing schedule ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| HonorHealth Research & Innovation Institute | Scottsdale | Arizona | 85258 | - |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | - |
| H. Lee Moffitt Cancer Center & Research Institute, Inc. | Tampa | Florida | 33612 | - |
| Texas Oncology, P.A. | Dallas | Texas | 75246 | - |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | - |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | - |
Find similar trials in Scottsdale, AZ
By research site
HonorHealth Research & Innovation Institute· Scottsdale, AZUniversity of Colorado Anschutz Medical Campus· Aurora, COH. Lee Moffitt Cancer Center & Research Institute, Inc.· Tampa, FLTexas Oncology, P.A.· Dallas, TXUniversity of Texas MD Anderson Cancer Center· Houston, TXInova Schar Cancer Institute· Fairfax, VA