Vismodegib for Fallopian Tube Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
UPMC Hillman Cancer Center, Pittsburgh, PA
Fallopian Tube Carcinoma+4 More
Vismodegib - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial will treat patients with platinum resistant ovarian, fallopian tube or primary peritoneal cancer as defined by a progression free interval within six months of completion of most recent platinum-based treatment with a combination of vismodegib and atezolizumab. Despite recent improvements in treatment of ovarian cancer with the introduction of PARP inhibitors, response rates to therapy in the platinum resistant setting remain dismal with response rates of only 10-20% reported for single agent cytotoxic therapies. Given the poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates.

Eligible Conditions

  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Fallopian Tube Carcinoma
  • Hedgehog Inhibitor
  • PARP Inhibitors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 36 months

Up to 36 months
Immune-modified Response Rate by imRECIST
Modified Response Rate by iRECIST
Objective Response Rate (ORR)
Overall Survival (OS)
Progression-free survival (PFS)
Up to two weeks
Safety Determined by Dose Limiting Toxicities (DLTs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

vismodegib + atezolizumab
1 of 1
Experimental Treatment

48 Total Participants · 1 Treatment Group

Primary Treatment: Vismodegib · No Placebo Group · Phase 2

vismodegib + atezolizumabExperimental Group · 2 Interventions: Atezolizumab, Vismodegib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2015
Completed Phase 4
~6340
Vismodegib
2016
Completed Phase 4
~980

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
Closest Location: UPMC Hillman Cancer Center · Pittsburgh, PA
Photo of UPMC Hillman Cancer Center 1Photo of UPMC Hillman Cancer Center 2Photo of UPMC Hillman Cancer Center 3
2007First Recorded Clinical Trial
1 TrialsResearching Fallopian Tube Carcinoma
62 CompletedClinical Trials

Who is running the clinical trial?

Ronald BuckanovichLead Sponsor
1 Previous Clinical Trials
35 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,482 Previous Clinical Trials
563,297 Total Patients Enrolled
Ronald J Buckanovich, MDPrincipal InvestigatorUPMC Hillman Cancer Center

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 years or older at the time of signing the informed consent form.
You have a life expectancy of 3 months or more.
You are able to comply with the study protocol.
The tumor must be either epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.
You have a disease that is resistant to platinum-based chemotherapy.
Measurable or non-measurable but evaluable disease per RECIST v1.1 {Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.
Availability of a representative tumor specimen for exploratory biomarker research will be required for 12 patients.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.