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

Sponsor

Pfizer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02462707

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: PF-03084014	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 1 Study Of Pf-03084014 To Evaluate Safety And Pharmacokinetics In Japanese Patients With Advanced Solid Tumors

Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-03084014	Drug: 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

Arm

Intervention/Treatment

Experimental: PF-03084014

Drug: 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

Outcome Measures

Primary Outcome Measures

First-cycle Dose Limiting Toxicities [during the first 28 days from the first dose]

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) [0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose]
QTc interval [from the first dose to the last dose]
Time to Reach Maximum Observed Plasma Concentration (Tmax) [0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose]
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose]
Plasma Decay Half-Life (t1/2) [0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose]
Apparent Oral Clearance (CL/F) [0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose]
Apparent Volume of Distribution at steady state (Vss/F) [0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose]
Minimum Observed Plasma Trough Concentration (Cmin) [0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose]
Average Serum Concentration at steady state (Cav) [0, 0.5, 1, 2, 4, 8, 24, 48, 96, 120 hours post-dose]
Accumulation Ratio (Rac) [0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and Day 21]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT02462707

Other Study ID Numbers:

A8641021

First Posted:

Jun 4, 2015

Last Update Posted:

Oct 7, 2015

Last Verified:

Aug 1, 2015

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Oct 7, 2015