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SP-002 + Vismodegib for Basal Cell Carcinoma

Phase 2
Recruiting
Research Sponsored by Stamford Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 36
Awards & highlights

Summary

This trial aims to see if adding SP-002 to current treatment for locally advanced Basal cell carcinoma is effective. They want to know the response rate of the tumors after 1 or 3 cycles

Who is the study for?
This trial is for individuals with locally advanced Basal cell carcinoma. Participants must be suitable for hedgehog pathway inhibitor therapy and willing to undergo additional treatment with SP-002. Specific eligibility details are not provided, but typically include factors like age, health status, and cancer stage.Check my eligibility
What is being tested?
The study tests the effectiveness of SP-002 when added to standard hedgehog pathway inhibitor therapy in treating Basal cell carcinoma. It compares tumor response rates across three groups: one receiving daily inhibitors plus 3 cycles of SP-002, another getting daily inhibitors plus 1 cycle of SP-002, and a third taking only the daily inhibitors.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include those commonly associated with cancer treatments such as fatigue, nausea, skin reactions or increased risk of infections due to immune system suppression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate
Secondary outcome measures
Duration of response
Incidence and severity of SP-002 and/or vismodegib related AEs.
Number of subjects discontinuing treatment with SP-002 and/or vismodegib due to toxicity.
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 2Experimental Treatment2 Interventions
vismodegib, with 1 cycles SP-002
Group II: Arm 1Experimental Treatment2 Interventions
vismodegib, with 3 cycles SP-002
Group III: Arm 3Placebo Group1 Intervention
vismodegib monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vismodegib
2015
Completed Phase 4
~1880

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Who is running the clinical trial?

Stamford Pharmaceuticals, Inc.Lead Sponsor
Stamford PharmaceuticalsStudy ChairStamford Pharmaceuticals
~53 spots leftby Sep 2026