Compassionate Use Protocol for PF-03084014 in Patients With Advanced Solid Tumor Malignancies
| Status: | No longer available |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 16 - 101 |
| Updated: | 2/3/2019 |
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.
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
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
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
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