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

NCT01018563 | Terminated Phase 2 Results

• 2 other identifiers: MORAb-003-002A2009-015825-36
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Epithelial Ovarian Cancer

Keywords

Extension study; Epithelial ovarian cancer

Outcome Measures

Primary Outcomes (1)

• Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response

  The duration of CA125 response, was defined the time from the date of the initial CA125 response (i.e., prior to enrollment in the parent study, was the starting point for assessment) to the first documentation of progressive disease (PD) by either Gynecologic Cancer Inter Group (GCIG) criteria for CA125 level or by the date of death due to any cause, whichever occurred first. Disease progression per CA125 was defined as the first of 2 consecutive CA125 values greater than (\>) twice the upper limit of normal (ULN) (i.e. 35 kilo unit per liter \[kU/L\]) on two occasions. C= data censored at earlier non-PD assessment if PD did not occur.

  From screening of parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

Secondary Outcomes (4)

• Progression-Free Survival (PFS) by GCIG

  From the first dose of study medication in the parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

• Overall Survival (OS)

  From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

• Duration of Second Remission

  From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

• Duration of Third Remission

  From Baseline (Day 1) of this study until date of death from any cause, or until the study was terminated (up to a maximum of 37.7 months)

Other Outcomes (1)

• Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria

  From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months)

Study Arms (1)

MORAb-003

EXPERIMENTAL

Maintenance infusions of MORAb-003 every 3 weeks

Drug: MORAb-003

Interventions

MORAb-003 DRUG

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

Also known as: Farletuzumab

MORAb-003

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Morphotek: lead

Study Sites (3)

Sharp Memorial Hospital

Chula Vista, California, 91911, United States

Location

South Texas Oncology & Hematology

San Antonio, Texas, 78229, United States

Location

Nationales Centrum fur Tumorerkrandungen

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

farletuzumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Limitations and Caveats

Study was terminated by sponsor due to futile results in the NCT00849667 (MORAb003-004) study.

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Medical Information

esi_medinfo@eisai.com

888 422 4743

Study Officials

• Susan Weil, MD

  Morphotek

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 23, 2009
• Study Start: January 13, 2010
• Primary Completion: March 5, 2013
• Study Completion: March 5, 2013
• Last Updated: December 8, 2021
• Results First Posted: December 8, 2021

Record last verified: 2015-11

Locations

DE (1); US (2)