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An Open Label Extension Study of the Efficacy of MORAb-003

NCT ID: NCT01018563

Last Updated: 2021-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-13

Study Completion Date

2013-03-05

Brief Summary

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An open label extension of the MORAb-003-002 study in order to continue the active patients in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.

Detailed Description

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Conditions

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Epithelial Ovarian Cancer

Keywords

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Extension study Epithelial ovarian cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MORAb-003

Maintenance infusions of MORAb-003 every 3 weeks

Group Type EXPERIMENTAL

MORAb-003

Intervention Type DRUG

Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks.

Interventions

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MORAb-003

Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks.

Intervention Type DRUG

Other Intervention Names

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Farletuzumab

Eligibility Criteria

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Inclusion Criteria

* Provision of Informed consent.

Exclusion Criteria

* Subjects must have achieved a normalization of CA 125 levels and/or CR or PR (or stable disease and an investigator's assessment of a clinical benefit) after MORAb-003 in combination with standard chemotherapy and have not yet met the criteria for disease progression during participation in the MORAb-003-002 study.
* Subjects must be currently receiving single-agent MORAb-003 maintenance therapy.


• Subjects that discontinued the MORAb-003-002 study for any reason.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Morphotek

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Weil, MD

Role: STUDY_DIRECTOR

Morphotek

Locations

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Sharp Memorial Hospital

Chula Vista, California, United States

Site Status

South Texas Oncology & Hematology

San Antonio, Texas, United States

Site Status

Nationales Centrum fur Tumorerkrandungen

Heidelberg, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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2009-015825-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MORAb-003-002A

Identifier Type: -

Identifier Source: org_study_id