Trials / No Longer Available
No Longer AvailableNCT02955446
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
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 16 Years – 101 Years
- Healthy volunteers
- —
Summary
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.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- First posted
- 2016-11-04
- Last updated
- 2019-02-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02955446. Inclusion in this directory is not an endorsement.