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

November 5, 2013 updated by: Morphotek

A Study of the Safety, Tolerability, and Pharamcokinetics of MORAb-003, a Humanized Monoclonal Antibody, in Subjects With Advanced Ovarian Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Morphotek

Investigators

  • Principal Investigator: Jason Konner, M.D., Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 28, 2007

First Submitted That Met QC Criteria

January 28, 2007

First Posted (Estimate)

January 30, 2007

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MORAb-003-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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