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

Phase 1

Withdrawn

• Conditions: Advanced Solid Tumors
• Interventions: Drug: PF-03084014

• Registration Number: NCT02462707
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-02
• Study First Posted: 2015-06-04
• Study Start: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-07
• Primary Completion: 2016-06
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-03084014	PF-03084014	-

Primary Outcome Measures

Name	Time	Method
First-cycle Dose Limiting Toxicities	during the first 28 days from the first dose

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	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
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
Accumulation Ratio (Rac)	0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and Day 21