A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014 single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated.

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-03084014

Group Type EXPERIMENTAL

PF-03084014

Intervention Type DRUG

gamma-secretase inhibitor, formulated in tablets for oral administration containing 10 mg, 50 mg and 100 mg. Patient will receive 80 mg, 100 mg or 150 mg twice daily of PF-03084014 with continuous dosing schedule

Interventions

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PF-03084014

gamma-secretase inhibitor, formulated in tablets for oral administration containing 10 mg, 50 mg and 100 mg. Patient will receive 80 mg, 100 mg or 150 mg twice daily of PF-03084014 with continuous dosing schedule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological diagnosis of advanced solid tumors that is resistant to standard therapy or for which no standard therapy is available.
* Age ≥18 years.
* ECOG Performance Status (PS) must be 0 or 1.
* Adequate Bone Marrow Function
* Adequate Renal Function
* Adequate Liver Function
* Resolved acute effects of any prior therapy to baseline severity or Grade ≤1

Exclusion Criteria

* Patients with known brain metastases
* Major surgery within 4 weeks of starting study treatment
* Radiation therapy within 2 weeks of starting study treatment
* Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study treatment
* Previous high dose chemotherapy requiring stem cell rescue
* Prior irradiation to \>25% of the bone marrow
* Prior treatment with a Notch signal inhibitor
* Known malabsorption syndrome or other condition that may impair absorption of study medication
* Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
* Current use or anticipated need for known strong and/or moderate CYP3A4 inhibitors
* Current use or anticipated need for known strong CYP3A4 inducers

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No