Trial Outcomes & Findings for Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas (NCT NCT01556009)
NCT ID: NCT01556009
Last Updated: 2020-11-02
Results Overview
Primary: i. To compare the efficacy of (i) intermittent vismodegib vs. (ii) the efficacy of photodynamic therapy (PDT) in preventing the return of the burden of surgically eligible BCCs (SEBs) to baseline level following 7 months of continuous vismodegib therapy. ii. To compare the cumulative diameter (burden) of SEBs in patients treated intermittently with vismodegib vs. with photodynamic therapy (PDT).
COMPLETED
PHASE2
24 participants
A Data Safety Monitoring Board (DSMB) will review results for an interim analysis when 12 subjects have completed 28 months.
2020-11-02
Participant Flow
The PI has left the institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
Participant milestones
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Drug (Vismodegib)
Vismodegib taken orally 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.
Vismodegib: 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.
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Aminolevulinic Acid %20 Topical Solution
Aminolevulinic acid HCL 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.
Aminolevulinic acid %20 topical solution: 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: A Data Safety Monitoring Board (DSMB) will review results for an interim analysis when 12 subjects have completed 28 months.Population: The PI has left the institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
Primary: i. To compare the efficacy of (i) intermittent vismodegib vs. (ii) the efficacy of photodynamic therapy (PDT) in preventing the return of the burden of surgically eligible BCCs (SEBs) to baseline level following 7 months of continuous vismodegib therapy. ii. To compare the cumulative diameter (burden) of SEBs in patients treated intermittently with vismodegib vs. with photodynamic therapy (PDT).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: A Data Safety Monitoring Board (DSMB) will review results for an interim analysis when 12 subjects have completed 28 months.Population: The PI has left the institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.
i. To assess the safety of intermittent vismodegib in patients with multiple BCCs (BCNS and non-BCNS) during months 8-28. ii. To assess resistance of SEBs to treatments in patients with multiple BCCs (BCNS and non-BCNS) treated intermittently during months 8-28. iii. To assess the degree of reduction of SEBs after 7 months of continuous daily vismodegib therapy. iv. To conduct an exploratory evaluation in non-BCNS patients with multiple BCCs (high burden of disease) of the efficacy and tolerability of intermittent vismodegib vs PDT
Outcome measures
Outcome data not reported
Adverse Events
Drug (Vismodegib)
Aminolevulinic Acid %20 Topical Solution
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ervin H Epstein Jr., MD
Children's Hospital of Oakland Research Institute, Oakland
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place