NCT00345540

Brief Summary

The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin in a cohort of women with platinum resistant cancer of ovarian origin.

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_2 ovarian-cancer

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2 ovarian-cancer

Geographic Reach
1 country

2 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

June 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
6.8 years until next milestone

Results Posted

Study results publicly available

March 10, 2015

Completed
Last Updated

March 10, 2015

Status Verified

January 1, 2009

Enrollment Period

1.8 years

First QC Date

June 26, 2006

Results QC Date

July 9, 2013

Last Update Submit

February 25, 2015

Conditions

Ovarian Cancer

Keywords

Platinum Resistant Tumors of Ovarian Origin

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    At treatment completion (8 weeks) and monthly until disease progression

Secondary Outcomes (2)

  • Safety of NOV-002 and Carboplatin

    Duration of trial and through 30-day follow-up period after final treatment

  • Progression Free Survival (PFS)

    From time of treatment start to time of disease progression

Study Arms (1)

NOV-002 plus Carboplatin

EXPERIMENTAL

NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.

Drug: NOV-002Drug: Carboplatin

Interventions

NOV-002DRUG

60 mg / mL / day / 20-23 Days

Also known as: Oxidized Glutathione
NOV-002 plus Carboplatin
CarboplatinDRUG

AUC 5 following IV bolus administration of NOV-002

Also known as: Paraplatin
NOV-002 plus Carboplatin

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • ECOG 0-1
  • Platinum resistant or refractory disease defined as progressive disease within 6 months of completing or while receiving their last platinum containing regimen
  • Measurable disease

You may not qualify if:

  • History of other malignancies within 2 years except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, incidental stage I endometrial cancer, basal or squamous cell skin cancer
  • Major surgery within 2 weeks of study entry
  • History of anaphylactic shock with prior platinum chemotherapy
  • Known history of central nervous system (CNS) metastases unless subject has had treatment with surgery or radiation therapy and is neurologically stable
  • Treatment with more than 3 lines of chemotherapy
  • Chronic use of systemic corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana Farber Cancer/Partners Cancer Care

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

NOV 002Glutathione DisulfideCarboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

GlutathioneOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsCoordination ComplexesOrganic Chemicals

Limitations and Caveats

The criterion for continuing to Stage II of the study (≥ 2 responses) was not met.

Results Point of Contact

Title
Vice President, Clinical Development
Organization
Novelos Therapeutics, Inc.
hpalmin@novelos.com
617-244-1616

Study Officials

  • Carolyn Kransner, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2006

First Posted

June 28, 2006

Study Start

July 1, 2006

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

March 10, 2015

Results First Posted

March 10, 2015

Record last verified: 2009-01

Locations

US(2)