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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2024-09-20)

To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma

๐ŸŸข Recruiting Phase 2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Stamford Pharmaceuticals, Inc.

๐Ÿฉบ Protocol Summary

The goal of this clinical trial is to evaluate the efficacy of using SP-002 in participants with locally advanced Basal cell carcinoma. The main question it aims to answer is what the objective response rate for a basal cell carcinoma tumor is following 1 or 3 cycles of SP-002 treatment given as an add-on to hedgehog pathway inhibitor therapy. Researchers will compare the objective response rate for treated Basal cell carcinoma tumors between 3 treatment Arms. * Arm 1 participants will receive daily hedgehog pathway inhibitor, and 3 cycles of SP-002 treatment. * Arm 2 participants will receive daily hedgehog pathway inhibitor, and 1 cycle of SP-002 treatment. * Arm 3 participants will receive daily hedgehog pathway inhibitor only.

Primary Research Facility: Research Site (Phoenix, Arizona)

๐Ÿ“‹ Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

๐Ÿ“ Primary Site Map

Site: Research Site โ€” Phoenix, Arizona

๐Ÿ“ All Participating Trial Locations (10 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Research Site โ€” Phoenix, Arizona
2. Research Site โ€” Boca Raton, Florida
3. Research Site โ€” Coral Springs, Florida
4. Research Site โ€” Cutler Bay, Florida
5. Research Site โ€” Rockville, Maryland
6. Research Site โ€” Lee's Summit, Missouri
7. Research Site โ€” Rochester, New York
8. Research Site โ€” Cedar Park, Texas
9. Research Site โ€” Humble, Texas
10. Research Site โ€” Longview, Texas

๐Ÿ“„ Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

๐Ÿ’ฐ Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act ยง 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

๐Ÿ’ก Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT06344052 โ€ข Last Synced: 2024-09-20
View on ClinicalTrials.gov โ†—
๐Ÿ“ž Call Desk ๐Ÿ“‹ Check Criteria