Safety Study of FP-1039 To Treat Cancer | NCT00687505

Studies
Safety Study of FP-1039 To Treat Cancer

NCT00687505

Sponsor

Five Prime Therapeutics, Inc.

Status

Completed

Last Update Posted

Dec 13, 2021Actual

Enrollment

39Actual

Phase

Phase 1

Conditions

Advanced Cancer

Interventions

FP-1039

Countries

United States

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

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

May 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

May 27, 2008

First Submission Date that Met QC Criteria

May 27, 2008

First Posted Date

May 30, 2008Estimated

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

Dec 9, 2021

Last Update Posted Date

Dec 13, 2021Actual

Name	Class
Parexel	INDUSTRY

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 primary purpose of this study is to evaluate the safety and tolerability of FP-1039, a new biologic treatment for cancer.

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

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Single ascending doses	Drug: FP-1039

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FP-1039	Drug	Intravenous weekly administration	1

Measure	Description	Time Frame
Safety and tolerability		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with metastatic or locally advanced unresectable solid tumors for which standard curative or supportive measures do not exist or are no longer effective
Male or female 18 years of age or older

Exclusion Criteria:

Presence or history of melanoma
Primary brain tumor
Presence or history of glaucoma

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karmanos Cancer Institute		Detroit	Michigan	48201	United States
START (South Texas Accelerated Research Therapeutics)

Intervention Browse Module

MeSH Terms

ID	Term
C559041	FP-1039

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided