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Arm 1 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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 36

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Stamford Pharmaceuticals, Inc.Lead Sponsor

Stamford PharmaceuticalsStudy ChairStamford Pharmaceuticals

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the safety profile of treatment arm 1 in relation to patient well-being?

"Based on our assessment at Power, Arm 1 is assigned a safety rating of 2 as this trial is in Phase 2. Although there is some data supporting its safety, no evidence has been found yet regarding its efficacy."

Answered by AI

In how many distinct clinics is this experimental investigation currently being conducted?

"Currently, patient recruitment is ongoing at 5 distinct sites. These encompass locations in Phoenix, Longview, and Lee's Summit among several others. Opting for the nearest facility is crucial to reduce travel burden when participating in this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "To Assess the Safety and Efficacy of SP-002 With Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06344052.

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