Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphotek
• Treatments: Farletuzumab

Criteria

Inclusion Criteria:

• Female subjects at least 18 years of age, with a histologically confirmed diagnosis of non-mucinous epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) in first relapse after a first remission of 6 to 18 months duration.

• Subjects must have undergone surgery. Subjects must have received primary chemotherapy, including at least one platinum agent.

• Subject is eligible for retreatment with the same chemotherapy regimen that was used to induce remission (Exception: may reduce the dose of or discontinue taxane if contraindicated due to neurotoxicity.)

• CA125 must have been elevated prior to original chemotherapy.

• CA125 must be elevated at the time of relapse.

• Life expectancy greater than or equal to 6 months, as estimated by the investigator.

• Eastern Cooperative Oncology Group performance status of 0, 1 or 2

• Subjects must consent to use a medically acceptable method of contraception throughout the study period and for 28 days after final MORAb-003 administration, unless surgically sterile.

• Any significant concomitant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1.

• Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

• Absolute neutrophil count (ANC) ≥ 1.2 x 10e9/L

• Platelet count ≥ 100 x 10e9/L

• Hemoglobin ≥ 8 g/dL

• Subject must be willing and able to provide written informed consent. Translations of informed consent information may be provided, subject to the local institutional review board's (IRB's) policy.

Exclusion Criteria:

• Known central nervous system (CNS) tumor involvement.

• Evidence of other active malignancy requiring treatment.

• Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).

• Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Exception:

Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible).

• Active serious systemic disease, including active bacterial or fungal infection.

• Active hepatitis or HIV infection.

• Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, interleukin 1 receptor antagonist [IL-1RA] or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.

• Treatment with a monoclonal antibody therapy AND have evidence of an immune or allergic reaction or documented HAHA.

• Maintenance of first remission by taxane or other chemotherapeutic agent(s).

• Initiation or planned initiation of cancer therapy not given to induce primary remission. Substitutions of agents materially similar to those used in the original regimen are permissible.

• Breast-feeding, pregnant, or likely to become pregnant during the study.