Safety, Tolerability and Pharmacokinetics of MORAb-003 in Subjects With Advanced Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
Morphotek
ClinicalTrials.gov Identifier:
NCT00428766
First received: January 28, 2007
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to establish the safest dose of MORAb-003 in subjects with advanced ovarian cancer. MORAb-003 is an antibody directed to an antigen on the surface of ovarian cancer cells.


Condition Intervention Phase
Epithelial Ovarian Cancer
Drug: MORAb-003
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Safety, Tolerability, and Pharamcokinetics of MORAb-003, a Humanized Monoclonal Antibody, in Subjects With Advanced Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Morphotek:

Estimated Enrollment: 24
Study Start Date: June 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female subjects, ≥18 years of age, with a histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal adenocarcinoma, with or without elevation of CA 125, confirmed at the Department of Pathology, Memorial Sloan-Kettering Cancer Center.
  2. Subject must have disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or lesions of less than 2 cm) supported by CA-125, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
  3. Subject must have failed at least a standard (platinum-containing) chemotherapy regimen and be considered platinum refractory or resistant.
  4. Life expectancy ≥3 months, as estimated by the investigator.
  5. Karnofsky performance status ≥70%.
  6. Subjects must be surgically sterile, postmenopausal, or using an effective form of contraception.
  7. Subjects undergoing treatment with other medications must have been on a stable medication regimen for at least 30 days prior to Study Day 1.
  8. Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

    Absolute neutrophil count (ANC) ≥1.5 x 109/L Platelet count ≥100 x 109/L Hemoglobin ≥10 g/dL Serum bilirubin ≤2.0 mg/dL Aspartate transaminase (AST) ≤2.5 x upper limit of normal (ULN) Alanine transaminase (ALT) ≤2.5 x ULN Serum creatinine ≤2.0 mg/dL Amylase ≤1.5 x ULN Lipase ≤1.5 x ULN

  9. Spirometry indicating a FEV1 of >79% of predicted.
  10. Subject must be willing and able to provide written informed consent.

Exclusion Criteria:

  1. Known central nervous system (CNS) tumor involvement.
  2. Evidence of other active malignancy.
  3. Active asthma or other chronic lung disease.
  4. 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).
  5. ECG demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
  6. Active serious systemic disease, including active bacterial or fungal infection.
  7. Chronic inflammatory bowel disease.
  8. Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to enrollment.
  9. Breast-feeding, pregnant, or likely to become pregnant during the study.
  10. Active hepatitis or HIV infection.
  11. Subjects who have received a previous monoclonal antibody therapy and have evidence of an immune or allergic reaction, or documented HAHA.
  12. Subjects with large ascites (≥500 cc based on results of most recent CT scan).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428766

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Morphotek
Investigators
Principal Investigator: Jason Konner, M.D. Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Martin Phillips, MD, Morphotek
ClinicalTrials.gov Identifier: NCT00428766     History of Changes
Other Study ID Numbers: MORAb-003-001
Study First Received: January 28, 2007
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 18, 2014