NCT01016054

Brief Summary

This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

6 months

First QC Date

November 16, 2009

Last Update Submit

February 26, 2013

Conditions

CarcinomaOvarian CancerOvarian DiseasesOvarian Neoplasms

Keywords

Clinical Trial, Phase1Combination Drug TherapypharmacokineticssafetyOvarian

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    Throughout the treatment

Secondary Outcomes (4)

  • Assessment of PK variables

    Treatment Arm A: Weeks 1 and 3 of each cycle. Treatment Arm B: Week 1 of each cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.

  • Incidence of anti-AGS-8M4 antibody formation

    Treatment Arm A: Day 1 of every other cycle and at Day 15 for the first cycle only. Treatment Arm B: Day 1 of every other cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.

  • Changes in tumor status per RECIST

    Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks.

  • Change in CA-125 levels

    Treatment Arm A: Day 1 and Day 15 of each cycle. Treatment Arm B: Day 1 of each cycle. In addition, samples will be drawn at the Safety F/U.

Study Arms (2)

A. PLD plus AGS-8M4

EXPERIMENTAL

Women with platinum resistent ovarian cancer

Biological: AGS-8M4Drug: Pegylated liposomal doxorubicin (PLD)

B. Carboplatin and gemcitabine plus AGS-8M4

EXPERIMENTAL

Women with platinum sensitive ovarian cancer

Biological: AGS-8M4Drug: gemcitabineDrug: carboplatin

Interventions

AGS-8M4BIOLOGICAL

IV infusion

A. PLD plus AGS-8M4B. Carboplatin and gemcitabine plus AGS-8M4
Pegylated liposomal doxorubicin (PLD)DRUG

IV infusion

A. PLD plus AGS-8M4
gemcitabineDRUG

IV infusion

B. Carboplatin and gemcitabine plus AGS-8M4
carboplatinDRUG

IV infusion

B. Carboplatin and gemcitabine plus AGS-8M4

Eligibility Criteria

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

You may qualify if:

  • Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
  • Subjects with either platinum resistant or platinum sensitive ovarian cancer
  • At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities
  • Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal as measured by echocardiogram or MUGA (ONLY required for platinum resistant patients)

You may not qualify if:

  • Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
  • Use of any investigational drug within 30 days prior to screening
  • Prior monoclonal antibody therapy other than Avastin
  • Avastin administration within 90 days of screening
  • History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

CarcinomaOvarian NeoplasmsOvarian Diseases

Interventions

liposomal doxorubicinGemcitabineCarboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Use Central Contact

    Agensys, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 18, 2009

Study Start

October 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

US(1)