An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects with Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015825-36-DE

Enrollment

Registered

2009-10-19

Start date

2010-01-27

Completion date

Unknown

Last updated

2013-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platinum-sensitive epithelial ovarian cancer

Interventions

Product Name: MORAb-003 Product Code: MORAb-003 Pharmaceutical Form: Solution for injection Current Sponsor code: MORAb-003 Other descriptive name: humanised IgG monoclonal antibody Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Provision of informed consent 2. Subjects must currently be enrolled in and have met the inclusion/exclusion criteria of the MORAb-003-002 study 3. 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 criteria for disease progression and during participation on MORAb-003-002 study 4. Subjects must be currently receiving single-agent MORAb-003 maintenance therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Subjects that discontinued the MORAb-003-002 study for any reason

Design outcomes

Primary

Measure	Time frame
Main Objective: To provide MORAb-003 to subjects who are enrolled in the protocol MORAb-003-002 and appear to be deriving benefit;Secondary Objective: To determine efficacy of continued multiple intravenous infusions of MORAb-003 in platinum-sensitive subjects with relapsed epithelial ovarian cancer including tumor assessment, ovarian tumor marker levels, durations of second and subsequent remissions, progression-free survival and overall survival To assess safety and tolerability of MORAb-003 To determine occurrence of human anti-human antibodies To identify molecular markers that can be used as a surrogate for response to immunotherapy and immunologic factors that may contribute to a prolonged second remission.;Primary end point(s): 1. CA125 (ovarian tumour marker) levels 2. Objective tumour measurement by computed tomography scan or magnetic resonance imaging & Response Evaluation Criteria in Solid Tumors 3. Duration of responses 4. Progression-free survival 5. Overall survival 6. Safety variables- including adverse events and laboratory values 7. Human anti-human antibodies to MORAb-003	—

Measure

Time frame

Main Objective: To provide MORAb-003 to subjects who are enrolled in the protocol MORAb-003-002 and appear to be deriving benefit;Secondary Objective: To determine efficacy of continued multiple intravenous infusions of MORAb-003 in platinum-sensitive subjects with relapsed epithelial ovarian cancer including tumor assessment, ovarian tumor marker levels, durations of second and subsequent remissions, progression-free survival and overall survival To assess safety and tolerability of MORAb-003 To determine occurrence of human anti-human antibodies To identify molecular markers that can be used as a surrogate for response to immunotherapy and immunologic factors that may contribute to a prolonged second remission.;Primary end point(s): 1. CA125 (ovarian tumour marker) levels 2. Objective tumour measurement by computed tomography scan or magnetic resonance imaging & Response Evaluation Criteria in Solid Tumors 3. Duration of responses 4. Progression-free survival 5. Overall survival 6. Safety variables- including adverse events and laboratory values 7. Human anti-human antibodies to MORAb-003

—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026