Clinical Trials Logo
  1. Home
  2. Carcinoma, Basal Cell
  3. NCT03897036

Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)

Carcinoma, Basal Cell Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

Basal cell carcinomas require the hedgehog (Hh) pathway for growth. Hh binding relieves the inhibitory effect of PTCH1 on Smoothened (SMO). Signal transduction by SMO then leads to the activation and nuclear localization of GLI1 transcription factors and induction of Hh target genes, many of which are involved in proliferation, survival, and angiogenesis. Hedgehog pathway inhibitors, such as vismodegib6 and sonidegib phosphate, target the G-protein-coupled receptor Smoothened (SMO) and are recommended as first-line treatment for advanced BCC or mBCC by the National Comprehensive Cancer Network. CK2 affects the terminal-most Hh signaling components. Given the roles of CK2 on the terminal step of the hedgehog signaling pathway, CK2 inhibition is unlikely to be overcome by downstream mutations within this pathway. These data thus suggest an immediately practical application of CX-4945 in Hh-driven tumors and possibly tumors resistant to SMO inhibitors. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03897036
Study type Interventional
Source Senhwa Biosciences, Inc.
Contact
Status Active, not recruiting
Phase Phase 1
Start date April 1, 2019
Completion date December 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT00875381 - Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin N/A
Recruiting NCT04362722 - Intratumoral Administration of Daromun in Non-melanoma Skin Cancer Patients Phase 2
Completed NCT00218829 - DMSO-PDT of BCC - A 6 Year Follow up N/A
Completed NCT02674009 - Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)
Recruiting NCT05970497 - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors Phase 1
Terminated NCT02956889 - To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma Phase 2
Completed NCT01204073 - A Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies Phase 1
Completed NCT02029352 - Topical Green Tea Ointment in Treatment of Superficial Skin Cancer Phase 2/Phase 3
Completed NCT03569345 - Basal Cell Carcinomas Treated With Ablative Fractional Laser and Ingenol Mebutate Phase 1/Phase 2
Recruiting NCT05463757 - Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study
Completed NCT00189280 - Aldara for the Treatment of Large and/or Multiple sBCC Phase 3
Completed NCT03541252 - Topical Laser-assisted Combination Chemotherapy for Basal Cell Carcinoma- a Clinical Study Phase 1/Phase 2
Recruiting NCT05133427 - HIFU for Treatment of Non-nodular and Recurrent BCC N/A
Active, not recruiting NCT02367547 - Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: HAL and BF-200 ALA Versus MAL Phase 1/Phase 2
Completed NCT00007631 - Determine the Efficacy of Topical Tretinoin Cream for the Prevention of Nonmelanoma Skin Cancer Phase 3
Active, not recruiting NCT05138328 - Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance N/A
Completed NCT03132636 - PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy Phase 2
Completed NCT00847912 - CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial Phase 4
Enrolling by invitation NCT02666833 - Optical Imaging for Preoperative Delineation of Nonmelanoma Skin Cancers N/A
Completed NCT01482104 - New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC) N/A