Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

Official title:

A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004380
• Other study ID #: MORAb-003-005
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2009
• Last updated: July 15, 2014
• Start date: November 2009
• Est. completion date: October 2012

Study information

• Verified date: July 2014
• Source: Morphotek
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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

1. is safe, or

2. to assess the potential drug-drug interaction, and

3. to prolong response to chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Previous treatment with MORAb 003 (farletuzumab)

• Previous treatment with anthracyclines

• Clinical contraindications to use PLD

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Epithelial Ovarian Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• Farletuzumab, Carboplatin, and 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham Medical Center	Birmingham	Alabama
United States	Schwartz Gynecologic Oncology	Brightwaters	New York
United States	Chattanooga GYN Oncology	Chattanooga	Tennessee
United States	International Beneficence Clinical Research, LLC	Harlingen	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Morphotek

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.		At all study visits.	Yes
Secondary	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.		Every 2 months	Yes