A Study of the Efficacy of MORAb-003 in Subjects with Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

Phase 2

Completed

Conditions: ovarian cancer
Ovarian carcinoma
10038597

Registration Number: NL-OMON30586

Lead Sponsor: Morphotek, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1. Female subjects, * 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.
2. Subjects must have undergone surgery. Subjects must have received primary chemotherapy, including at least one platinum agent.
3. 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.)
4. CA125 must have been elevated prior to original chemotherapy.
5. CA125 must be elevated at the time of relapse.
6. Life expectancy * 6 months, as estimated by the investigator.
7. Eastern Cooperative Oncology Group performance status or 0, 1 or 2 (see Appendix D).
8. 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.
9. 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.
10. Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
Absolute neutrophil count (ANC) * 1.2 x 109/L
Platelet count * 100 x 109/L
Hemoglobin * 8 g/dL
13. Subject must be willing and able to provide written informed consent. Translations of informed consent information may be provided, subject to the local IRB*s policy.

Exclusion Criteria

1. Known central nervous system (CNS) tumor involvement.
2. Evidence of other active malignancy requiring treatment.
3. 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).
4. ECG demonstrating clinically significant arrhythmias (Exception: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
5. Active serious systemic disease, including active bacterial or fungal infection.
6. Active hepatitis or HIV infection.
7. Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, IL-1RA or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.
8. Treatment with a monoclonal antibody therapy AND have evidence of an immune or allergic reaction or documented HAHA.
9. Maintenance of first remission by taxane or other chemotherapeutic agent(s).
10. 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.
11. Breast-feeding, pregnant, or likely to become pregnant during the study.