A Study Of PF-03084014 In Japanese Patients With Advanced... | NCT02462707

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

NCT02462707

Sponsor

Pfizer

Status

Withdrawn

Last Update Posted

Oct 7, 2015Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Advanced Solid Tumors

Interventions

PF-03084014

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Jun 2, 2015

First Submission Date that Met QC Criteria

Jun 2, 2015

First Posted Date

Jun 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2015

Last Update Posted Date

Oct 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PF-03084014	Experimental		Drug: PF-03084014

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-03084014	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First-cycle Dose Limiting Toxicities		during the first 28 days from the first dose

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided