Epithelial Ovarian CancerPhase 1NCT01004380
Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer
A Phase 1 study testing Farletuzumab, Carboplatin, and PLD in people with Epithelial Ovarian Cancer, run by Morphotek at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe. 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?
- Farletuzumab, Carboplatin, and PLD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2009to Oct 2012
- 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
- Diagnosis of epithelial ovarian cancer
- Must have measurable disease by CT or MRI scan
- Must have relapsed as defined by CA-125 or radiologically within 6 months or more of completion of first- or second-line platinum chemotherapy
- Must have been treated with surgery and be a candidate for repeat carboplatin therapy
- Must have a normal cardiac ejection fraction at baseline
Who cannot join
- Subjects who never responded to first- or second-line platinum-based chemotherapy or whose relapse occurs <6 months from the last platinum therapy
- Subjects who have received other therapy to treat their ovarian cancer since last relapse
- Known central nervous system tumor involvement
- Evidence of other active invasive malignancy
- Clinically significant heart disease
- Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
Show all 9Show fewer
- Previous treatment with MORAb 003 (farletuzumab)
- Previous treatment with anthracyclines
- Clinical contraindications to use PLD
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins University
Baltimore, Maryland, 21205
University of Alabama at Birmingham Medical Center
Birmingham, Alabama, 35293
Schwartz Gynecologic Oncology
Brightwaters, New York, 11718
Chattanooga GYN Oncology
Chattanooga, Tennessee, 37403
International Beneficence Clinical Research, LLC
Harlingen, Texas, 78550
About this study
Official title: A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer
The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.
Read the detailed description
Farletuzumab (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) in combination with other drugs. Farletuzumab 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 the combination therapy of farletuzumab, carboplatin, and PLD
- is safe, or
- to assess the potential drug-drug interaction, and
- to prolong response to chemotherapy.
- Conditions
- Epithelial Ovarian Cancer
- Being tested
- Farletuzumab, Carboplatin, and PLD
- Keywords
- Epithelial Ovarian Cancer, Ovarian Cancer
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Farletuzumab, Carboplatin, and PLDDrug
Also called Farletuzumab (MORAb-003), Carboplatin, PLD
All subjects will receive approximately 6 cycles with carboplatin (AUC5-6) i.v. and PLD (30 mg/m2) i.v. on Day 1 of every 4-week Combination treatment cycle. In addition, subjects will also receive weekly farletuzumab at 2.5 mg/kg administered i.v. Following completion of the Combination treatment period (carboplatin/PLD/farletuzumab therapy),maintenance treatment with single agent farletuzumab will be administered once Q3W at 7.5 mg/kg until disease progression as defined by GCIG CA-125 (i.e., CA-125 is less than or equal to 2 × (ULN) documented on 2 occasions) or modified RECIST v.1.0 using CT or MRI.
| Study group | Role | What they receive |
|---|---|---|
| Farletuzumab | Experimental | 2.5 mg/kg once weekly administered i.v. during the Combination treatment period and 7.5 mg/kg Q3W administered i.v. during the Maintenance period Receives: Drug: Farletuzumab, Carboplatin, and PLD |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.
Measured: At all study visits.
Secondary outcomes (1)
To assess the effect of farletuzumab in combination with carboplatin and PLD on best objective response rate, time to response, and duration of response by RECIST criteria.
Measured: Every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Weil, MD, Study director, Morphotek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004380
- Sponsor's protocol ID
- MORAb-003-005
- Status last verified
- Jul 2014
- First submitted
- 20 Oct 2009
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer
- ClinicalTrials.gov ID
- NCT01004380
- Acronym / sponsor ID
- MORAb-003-005
- Conditions
- Epithelial Ovarian Cancer
- Keywords
- Epithelial Ovarian Cancer, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- MorphotekIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 29 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.
Detailed description
Farletuzumab (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) in combination with other drugs. Farletuzumab 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 the combination therapy of farletuzumab, carboplatin, and PLD
- is safe, or
- to assess the potential drug-drug interaction, and
- to prolong response to chemotherapy.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Farletuzumab | Experimental | Drug: Farletuzumab, Carboplatin, and PLD2.5 mg/kg once weekly administered i.v. during the Combination treatment period and 7.5 mg/kg Q3W administered i.v. during the Maintenance period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of epithelial ovarian cancer
- Must have measurable disease by CT or MRI scan
- Must have relapsed as defined by CA-125 or radiologically within 6 months or more of completion of first- or second-line platinum chemotherapy
- Must have been treated with surgery and be a candidate for repeat carboplatin therapy
- Must have a normal cardiac ejection fraction at baseline
Key exclusion criteria (9 listed)
- Subjects who never responded to first- or second-line platinum-based chemotherapy or whose relapse occurs <6 months from the last platinum therapy
- Subjects who have received other therapy to treat their ovarian cancer since last relapse
- Known central nervous system tumor involvement
- Evidence of other active invasive malignancy
- Clinically significant heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Farletuzumab, Carboplatin, and PLDAlso: Farletuzumab (MORAb-003), Carboplatin, PLDAll subjects will receive approximately 6 cycles with carboplatin (AUC5-6) i.v. and PLD (30 mg/m2) i.v. on Day 1 of every 4-week Combination treatment cycle. In addition, subjects will also receive weekly farletuzumab at 2.5 mg/kg administered i.v. Following completion of the Combination treatment period (carboplatin/PLD/farletuzumab therapy),maintenance treatment with single agent farletuzumab will be administered once Q3W at 7.5 mg/kg until disease progression as defined by GCIG CA-125 (i.e., CA-125 is less than or equal to 2 × (ULN) documented on 2 occasions) or modified RECIST v.1.0 using CT or MRI. | Drug | Farletuzumab |
Primary outcome
To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.
Time frame: At all study visits.
1 secondary outcome
To assess the effect of farletuzumab in combination with carboplatin and PLD on best objective response rate, time to response, and duration of response by RECIST criteria.
Time frame: Every 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Weil, MD study director
Morphotek
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Farletuzumab, Carboplatin, and PLD in people with Epithelial Ovarian Cancer, run by Morphotek at 5 sites 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 5 inclusion and 9 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 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does the primary outcome measure?
To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer. (time frame: At all study visits.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2014.