Actively Recruiting
To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
Led by Stamford Pharmaceuticals, Inc. · Updated on 2024-09-20
80
Participants Needed
10
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Assess the Safety and Efficacy of SP-002 with Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent before starting study procedures
- Aged 18 years or older
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Has a single histologically confirmed Basal Cell Carcinoma lesion between 1 cm and 5 cm in longest diameter
- Lesion is not a good candidate for surgery, has recurred after surgery, or surgery is medically contraindicated
- Radiotherapy is contraindicated or inappropriate as judged by the investigator
- Able and willing to comply with all study requirements including biopsies
- Adequate blood cell counts and coagulation parameters
- Adequate liver function within specified laboratory limits
- Adequate kidney function within specified laboratory limits
- For females of childbearing potential, agreement to use two acceptable contraception methods during the study and for 24 months after stopping vismodegib
- For males with female partners of childbearing potential, agreement to use latex condoms and advise partners to use additional contraception during the study and for 24 months after stopping vismodegib
- Agreement not to donate blood or sperm during the study and for specified periods after stopping vismodegib
You will not qualify if you...
- Basal Cell Carcinoma that has progressed on systemic hedgehog pathway inhibitor therapy
- Basal Cell Carcinoma that recurred after two or more surgeries or after radiation therapy
- Basal Cell Carcinoma with bone involvement
- Basal Cell Carcinoma invading soft tissue inaccessible by needle
- Evidence of metastatic Basal Cell Carcinoma
- Female subjects who are pregnant or breastfeeding
- Life expectancy less than 12 weeks
- Taking other anti-tumor therapies not specified in the study
- Recent or planned participation in another experimental drug study within 4 weeks
- History of other malignancies within 3 years except for certain low-risk skin or cervical cancers
- Uncontrolled medical illnesses such as infections requiring intravenous antibiotics
- Other medical conditions that contraindicate investigational drug use or affect study results or participant safety
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Research Site
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Research Site
Boca Raton, Florida, United States, 33321
Actively Recruiting
3
Research Site
Coral Springs, Florida, United States, 33065
Actively Recruiting
4
Research Site
Cutler Bay, Florida, United States, 33157
Actively Recruiting
5
Research Site
Rockville, Maryland, United States, 20850
Actively Recruiting
6
Research Site
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
7
Research Site
Rochester, New York, United States, 14564
Actively Recruiting
8
Research Site
Cedar Park, Texas, United States, 78613
Actively Recruiting
9
Research Site
Humble, Texas, United States, 77346
Actively Recruiting
10
Research Site
Longview, Texas, United States, 75601
Actively Recruiting
Research Team
S
Stamford Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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