A Phase I Study of BIIB015 in Relapsed/Refractory Solid T... | NCT00674947

Studies
A Phase I Study of BIIB015 in Relapsed/Refractory Solid Tumors

NCT00674947

Sponsor

Biogen

Status

Completed

Last Update Posted

Sep 16, 2013Estimated

Enrollment

55Actual

Phase

Phase 1

Conditions

Solid Tumors

Interventions

BIIB015

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

Sep 2011

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

Jun 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

May 6, 2008

First Submission Date that Met QC Criteria

May 7, 2008

First Posted Date

May 8, 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

Sep 12, 2013

Last Update Posted Date

Sep 16, 2013Estimated

Description Module

Brief Summary

Phase 1, open-labeled, safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.

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

55Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIIB015	Drug	IV infusion once every 3 weeks until disease progression or unacceptable toxicity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate safety		ongoing
To determine the maximum-tolerated dose (MTD)		ongoing

Secondary Outcomes

Measure	Description	Time Frame
To evaluate pharmacokinetics (PK)		ongoing
To evaluate clinical activity		ongoing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Age 18 years or older at the time of informed consent.
Solid tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists.
ECOG Performance Status </= 2.

Exclusion Criteria

History of keratoconjunctivitis, open or closed angle glaucoma, or "dry eye" disease.
New York Heart Association (NYHA) Grade II or greater congestive heart failure.
History of myocardial infarction within 6 months prior to Day 1.
Presence of >/= Grade 2 peripheral neuropathy.
Known presence of central nervous system or brain metastases.
Prior therapy with a conjugated or unconjugated maytansine derivative.

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
Research Site		Santa Monica	California		United States
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D012008	Recurrence

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C568070	huB3F6-SPDB-DM4 immunoconjugate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided