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Epithelial Ovarian CancerPhase 2NCT01018563

An Open Label Extension Study of the Efficacy of MORAb-003

A Phase 2 study testing MORAb-003 in people with Epithelial Ovarian Cancer, run by Morphotek at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

An open label extension of the MORAb-003-002 study in order to continue the active patients in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed. 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
3 sitesin 2 countries
Study dates
13 Jan 2010to 5 Mar 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Provision of Informed consent.
  • Subjects must have been enrolled in and have met the inclusion/exclusion criteria of the MORAb-003-002 study.
  • Subjects must have achieved a normalization of CA 125 levels and/or CR or PR (or stable disease and an investigator's assessment of a clinical benefit) after MORAb-003 in combination with standard chemotherapy and have not yet met the criteria for disease progression during participation in the MORAb-003-002 study.
  • Subjects must be currently receiving single-agent MORAb-003 maintenance therapy.

Who cannot join

  • Subjects that discontinued the MORAb-003-002 study for any reason.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Sharp Memorial Hospital

    Chula Vista, California, 91911

  • South Texas Oncology & Hematology

    San Antonio, Texas, 78229

Other trials in United States

Germany1 site

  • Nationales Centrum fur Tumorerkrandungen

    Heidelberg, 69120

Other trials in Germany

About this study

Official title: An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

An open label extension of the MORAb-003-002 study in order to continue the active patients in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.

Being tested
MORAb-003
Keywords
Extension study, Epithelial ovarian cancer
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

    Also called Farletuzumab

    Dose group to be determined by dose assigned in main study and patient's weight. Intravenous infusions are given every 3 weeks.

Study groups in NCT01018563
Study groupRoleWhat they receive
MORAb-003ExperimentalMaintenance infusions of MORAb-003 every 3 weeks
Receives: Drug: MORAb-003

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response

    The duration of CA125 response, was defined the time from the date of the initial CA125 response (i.e., prior to enrollment in the parent study, was the starting point for assessment) to the first documentation of progressive disease (PD) by either Gynecologic Cancer Inter Group (GCIG) criteria for CA125 level or by the date of death due to any cause, whichever occurred first. Disease progression per CA125 was defined as the first of 2 consecutive CA125 values greater than (>) twice the upper limit of normal (ULN) (i.e. 35 kilo unit per liter [kU/L]) on two occasions. C= data censored at earlier non-PD assessment if PD did not occur.

    Measured: From screening of parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

Secondary outcomes (4)

  1. Progression-Free Survival (PFS) by GCIG

    PFS was defined as the time from the date of first dose of study medication during the parent study MORAb-003-002 (NCT00318370) to the date of disease progression (either by GCIG for CA125 criteria or standard RECIST v.1.0 criteria) or to the date of death due to any cause in this study. PD per CA125 was defined as the first of 2 consecutive CA125 values >2*ULN (35 kU/L) on two occasions. Participants who were alive with no disease progression were censored at either the date of last CA125 assessment or date of last objective tumor evaluation, whichever was later. PFS was also censored if a participant received a non-study anticancer therapy or procedure, with censoring occurring at the date of the last RECIST or CA125 assessment prior to the start of a non-study anticancer therapy or procedure (whichever was earlier). C= data censored at earlier non-PD assessment if PD did not occur.

    Measured: From the first dose of study medication in the parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

  2. Overall Survival (OS)

    OS was defined from the date of first dose of farletuzumab during the parent study MORAb-003-002 (NCT00318370) to date of death due to any cause. Participants who were alive had their OS time censored at the date they were last known to be alive. C= data censored at date participant was last known to be alive.

    Measured: From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

  3. Duration of Second Remission

    The prolongation of second and subsequent responses to chemotherapy plus farletuzumab relative to initial remission was assessed. Length of first remission was determined in the parent study MORAb-003-002 (NCT00318370). The length of second remission (i.e., the first remission in this study) was calculated using the following formula: '(carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1/30.4'. The length of second remission was censored at the date of study discontinuation if the participant did not receive any carboplatin/taxane therapy during this study. C = censored data.

    Measured: From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)

  4. Duration of Third Remission

    The length of third remission (i.e., second remission in this study) was calculated using the following formula: '(subsequent carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1)/30.4'. The length of third remission was censored at the date of study discontinuation if the participant did not receive subsequent chemotherapy (carboplatin/taxane) during this study. Censored data is reported for all participants.

    Measured: From Baseline (Day 1) of this study until date of death from any cause, or until the study was terminated (up to a maximum of 37.7 months)

Timeline

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

  1. First posted23 Nov 2009 (estimated)
  2. Study start13 Jan 2010
  3. Primary completion5 Mar 2013
  4. Study completion5 Mar 2013

Why it stopped: Study was terminated by sponsor due to futile results in NCT00849667 study.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01018563
Sponsor's protocol ID
MORAb-003-002A
Other IDs
2009-015825-36, 2009
Status last verified
Nov 2015
First submitted
18 Nov 2009
Last updated
8 Dec 2021
Data monitoring committee
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MORAb-003 in people with Epithelial Ovarian Cancer, run by Morphotek at 3 sites in 2 countries.

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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response (time frame: From screening of parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01018563.

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 8 Dec 2021.

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