Clinical trial NCT01018563: An Open Label Extension Study of the Efficacy of MORAb-003
Official title: An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Epithelial Ovarian Cancer
Keywords: Extension study
Epithelial ovarian cancer
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Provision of Informed consent.
* Subjects must have been enrolled in and have met the inclusion/exclusion criteria of the MORAb-003-002 study.
* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response
timeFrame: 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:
measure: Progression-Free Survival (PFS) by GCIG
timeFrame: 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)
measure: Overall Survival (OS)
timeFrame: 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)
measure: Duration of Second Remission
timeFrame: 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)
measure: Duration of Third Remission
timeFrame: 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:
measure: Number of Participants With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria
timeFrame: From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months)
Locations:
city: Chula Vista
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Antonio
country: United States
facility: South Texas Oncology & Hematology
state: Texas
city: Heidelberg
country: Germany
facility: Nationales Centrum fur Tumorerkrandungen
Study officials:
affiliation: Morphotek
name: Susan Weil, MD
role: STUDY_DIRECTOR
References: