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Epithelial Ovarian CancerPhase 1NCT00428766

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

A Phase 1 study testing MORAb-003 in people with Epithelial Ovarian Cancer, run by Morphotek at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
MORAb-003
How many people
24 participants
Where
1 siteUnited States
Study dates
Jun 2005to Dec 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • Subject must have failed at least a standard (platinum-containing) chemotherapy regimen and be considered platinum refractory or resistant.
  • Life expectancy ≥3 months, as estimated by the investigator.
  • Karnofsky performance status ≥70%.
  • Subjects must be surgically sterile, postmenopausal, or using an effective form of contraception.
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  • Subjects undergoing treatment with other medications must have been on a stable medication regimen 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) ≥1.5 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
  • Spirometry indicating a FEV1 of >79% of predicted.
  • Subject must be willing and able to provide written informed consent.

Who cannot join

  • Known central nervous system (CNS) tumor involvement.
  • Evidence of other active malignancy.
  • Active asthma or other chronic lung disease.
  • 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).
  • ECG demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
  • Active serious systemic disease, including active bacterial or fungal infection.
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  • Chronic inflammatory bowel disease.
  • Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to enrollment.
  • Breast-feeding, pregnant, or likely to become pregnant during the study.
  • Active hepatitis or HIV infection.
  • Subjects who have received a previous monoclonal antibody therapy and have evidence of an immune or allergic reaction, or documented HAHA.
  • Subjects with large ascites (≥500 cc based on results of most recent CT scan).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

Other trials in United States

About this study

Official title: 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.

Being tested
MORAb-003
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MORAb-003Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2007 (estimated)
  2. Study startJun 2005
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00428766
Sponsor's protocol ID
MORAb-003-001
Status last verified
Nov 2013
First submitted
28 Jan 2007
Last updated
6 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MORAb-003 in people with Epithelial Ovarian Cancer, run by Morphotek at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00428766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.

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