- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02955446
Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies
January 30, 2019 updated by: University of Colorado, Denver
Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies: Continuing Study Drug Administration in Desmoid Patients Receiving Clinical Benefit
This is a single-center, open label, non randomized, compassionate use protocol in patients with advanced solid tumor malignancies who were previously enrolled in the phase I study (NCT00878189) of this agent.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Detailed Description
This is an expanded access-physician sponsored trial of PF-03084014, a novel gamma-secretase inhibitor being developed for cancer therapy.
This trial is designed for patients who have been on a previous Industry-sponsored phase I trial using PF-03084014 for> 1 year.
The study is designed to evaluate the safety of prolonged oral administration of single agent PF-03084014.
There are two study subjects with desmoid tumor who have been on the trial for a prolonged period of time (54 and 77 months, respectively) with either stable disease or response, indicating significant clinical benefit for a patient population in which there are few options.
The goal of this protocol is to allow these subjects, who are clearly benefiting from PF-03084014, to continue to receive it
Study Type
Expanded Access
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 101 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who are currently enrolled in A8641014 for > 1 year are eligible
Exclusion Criteria:
- Prior treatment with a gamma secretase inhibitor for treatment of cancer
- Patients taking Tamoxifen
- Patients with active graft versus host disease
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
- Patients who are pregnant or breast-feeding
- Patients with clinical evidence of central nervous system disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 2016
First Submitted That Met QC Criteria
November 2, 2016
First Posted (Estimate)
November 4, 2016
Study Record Updates
Last Update Posted (Actual)
February 1, 2019
Last Update Submitted That Met QC Criteria
January 30, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-2088.cc
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasm
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedMetastatic Malignant Neoplasm | Unresectable Malignant Neoplasm | Advanced Malignant NeoplasmUnited States
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National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Malignant Neoplasm in the Liver | Unresectable Solid NeoplasmUnited States, Canada
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Ronald LevyBristol-Myers SquibbCompletedAdvanced Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Extracranial Solid NeoplasmUnited States
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National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
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Massachusetts General HospitalRecruitingMalignant Neoplasm | Benign NeoplasmUnited States
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National Cancer Institute (NCI)Active, not recruitingRefractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
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National Cancer Institute (NCI)Active, not recruitingAdvanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States, Canada
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Malignant Neoplasm | Advanced Malignant Neoplasm | Recurrent Malignant Neoplasm | Refractory Malignant Neoplasm | Locally Advanced Malignant NeoplasmUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Refractory NeoplasmUnited States
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M.D. Anderson Cancer CenterActive, not recruitingRefractory Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid NeoplasmUnited States
Clinical Trials on PF-03084014
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PfizerTerminatedTriple Negative Breast NeoplasmsSpain, United Kingdom, United States, Italy, Hungary, Poland
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PfizerWithdrawnAdvanced Solid Tumors
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PfizerCompletedNeoplasms by Histologic TypeUnited States, Italy
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AIDS Malignancy ConsortiumNational Cancer Institute (NCI); The Emmes Company, LLCWithdrawnHIV Infection | AIDS-related Kaposi Sarcoma | Recurrent Kaposi Sarcoma
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Jules Bordet InstituteWithdrawnBreast CancerBelgium, France
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SpringWorks Therapeutics, Inc.Active, not recruitingOvarian Cancer | Ovarian Granulosa Cell Tumor | Ovarian Granulosa-Stromal TumorUnited States, Canada, Poland
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National Cancer Institute (NCI)CompletedDesmoid Tumors | Aggressive FibromatosisUnited States
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PfizerTerminatedBreast Cancer MetastaticUnited States, Spain, Belgium, Italy
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SpringWorks Therapeutics, Inc.Active, not recruitingDesmoid Tumor | Aggressive FibromatosisUnited States, Belgium, Germany, Canada, Italy, Netherlands, United Kingdom