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Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies

Expanded access is no longer available for this treatment.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02955446
First received: November 2, 2016
Last updated: June 16, 2017
Last verified: June 2017
November 2, 2016
June 16, 2017
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Complete list of historical versions of study NCT02955446 on ClinicalTrials.gov Archive Site
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Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies
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.
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
Expanded Access:   Available for Treatment IND/Protocol
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  • Neoplasm
  • Desmoid Tumor
Drug: PF-03084014
Two patients enrolled in this study will continue receiving 80mg BID doses of PF-03084014, which was the same dose/schedule of their latest cycle on protocol A8641014. PF-03084014 will be administered twice a day in the morning and evening divided by approximately 12 hours. PF-03084014 should be administered in cycles of 21 days continuously.
Other Name: Gamma Secretase Inhibitor
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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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
Sexes Eligible for Study: All
16 Years to 101 Years   (Child, Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02955446
15-2088.cc
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University of Colorado, Denver
University of Colorado, Denver
Pfizer
Principal Investigator: Wells Messersmith, MD University of Colorado, Denver
University of Colorado, Denver
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP