NCT01004380

Brief Summary

The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2009

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

July 17, 2014

Status Verified

July 1, 2014

Enrollment Period

2.8 years

First QC Date

October 20, 2009

Last Update Submit

July 15, 2014

Conditions

Epithelial Ovarian Cancer

Keywords

Epithelial Ovarian CancerOvarian Cancer

Outcome Measures

Primary Outcomes (1)

  • To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer.

    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.

    Every 2 months

Study Arms (1)

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

Drug: Farletuzumab, Carboplatin, and PLD

Interventions

Farletuzumab, Carboplatin, and PLDDRUG

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 Ă— (ULN) documented on 2 occasions) or modified RECIST v.1.0 using CT or MRI.

Also known as: Farletuzumab (MORAb-003), Carboplatin, PLD
Farletuzumab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35293, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Schwartz Gynecologic Oncology

Brightwaters, New York, 11718, United States

Location

Chattanooga GYN Oncology

Chattanooga, Tennessee, 37403, United States

Location

International Beneficence Clinical Research, LLC

Harlingen, Texas, 78550, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialOvarian Neoplasms

Interventions

farletuzumabCarboplatin1-dodecylpyridoxal

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Susan Weil, MD

    Morphotek

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 29, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

July 17, 2014

Record last verified: 2014-07

Locations

US(5)