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

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

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Trial Information

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

MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against
epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma)
either alone or in combination with other drugs. MORAb-003 works by a different mechanism
from other cancer therapeutics and has been shown to be well tolerated. This study allows
the opportunity to determine if MORAb-003 can work either as a single agent

1. to treat a CA125-only relapse, or

2. in combination with standard platinum and taxane chemotherapy to treat a symptomatic
relapse, and

3. to prolong a second response to chemotherapy.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Serologic Response (Change in CA125 Level)

Outcome Description:

Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).

Outcome Time Frame:

Baseline to response (up to 30 weeks)

Safety Issue:


Principal Investigator

Susan C. Weil, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

June 2010

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
  • Ovarian Cancer
  • Primary Fallopian Tube Cancer
  • Peritoneal Cancer
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Johns Hopkins University Baltimore, Maryland  21205
Cooper University Hospital Camden, New Jersey  08103
Mary Crowley Medical Research Center Dallas, Texas  75246
Tyler Cancer Center Tyler, Texas  75702
The Center for Cancer and Hematologic Disease Cherry Hill, New Jersey  08003
Sharp Healthcare San Diego, California  92121
Gabrail Cancer Center Canton, Ohio  44718
Hematology and Oncology Specialists, LLC New Orleans, Louisiana  70115
St. Vincent Gynecologic Oncology Indianapolis, Indiana  46260
The Cancer Institute of New Jersey New Brunswick, New Jersey  08901
New York Oncology Hematology Albany, New York  12208
South Texas Oncology & Hematology San Antonio, Texas  78207
Northern Virginia Pelvic Surgery Associates Annandale, Virginia  22003
Jayne Gurtler, M.D. Metairie, Louisiana  70006
Lehigh Valley Women's Cancer Center Allentown, Pennsylvania  18104
Gynecology Oncology Research & Development Greenville, South Carolina  29601
Peninsula Cancer Center Newport News, Virginia  23601