NCT00035100

Brief Summary

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
5 countries

8 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

Study Start

First participant enrolled

September 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Last Updated

April 16, 2012

Status Verified

April 1, 2012

Enrollment Period

1.7 years

First QC Date

May 2, 2002

Last Update Submit

April 13, 2012

Conditions

Ovarian NeoplasmsPeritoneal NeoplasmsFallopian Tube Neoplasms

Keywords

ovarianovaryperitoneal cancerfallopian cancercancertumortumourneoplasmcarcinomaintravenousepothilone

Outcome Measures

Primary Outcomes (1)

  • Tumor response rate

    tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).

    Every 2 cycles

Secondary Outcomes (5)

  • Time to disease progression

    from start of treatment to documented disease progression, death from study indication, or the date of last follow-up

  • Overall survival

    measured from the start of treatment to the date of death or the last date the patient was known to be alive.

  • Duration of response

    Every 3 months

  • recording all adverse events (AEs) and serious adverse events (SAEs)

    Every 3 months

  • pharmacogenetic analyses with blood and tumor samples from these patients

    Every 3 months

Study Arms (1)

EPO906

EXPERIMENTAL
Drug: epothilone b

Interventions

epothilone bDRUG
Also known as: EPO906
EPO906

Eligibility Criteria

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

You may qualify if:

  • The following patients may be eligible for the study:
  • Histologically or cytologically documented evidence of ovarian, primary Fallopian or primary peritoneal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
  • Must have a life expectancy of greater than three (3) months
  • Prior failure to respond following front-line treatment with a taxane and platinum (or a combination therapy) may be eligible.

You may not qualify if:

  • The following patients are not eligible for the study:
  • Patients with radiation therapy or chemotherapy within the last four weeks
  • Patients who have had any chemotherapy not containing a taxane and platinum for their disease
  • Patients with borderline ovarian and macropapillary tumors
  • Patients with unresolved bowel obstruction
  • Patients with symptomatic CNS metastases or leptomeningeal involvement
  • Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
  • Patients with severe cardiac insufficiency
  • Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
  • History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
  • Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
  • HIV+ patients
  • Pregnant or lactating females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Novartis Investigative Site

New Brunswick, New Jersey, 08901, United States

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Enschede, Netherlands, 7513 ER, Netherlands

Location

Novartis Investigative Site

Amsterdam, 1066 CX, Netherlands

Location

Novartis Investigative Site

Zwolle, 8025 AB, Netherlands

Location

Novartis Investigative Site

Bratislava, 812 50, Slovakia

Location

Novartis Investigative Site

Košice, 04190, Slovakia

Location

Novartis Investigative Site

Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Ovarian NeoplasmsPeritoneal NeoplasmsFallopian Tube NeoplasmsNeoplasmsCarcinoma

Interventions

epothilone B

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersAbdominal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesFallopian Tube DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 2, 2002

First Posted

May 3, 2002

Study Start

September 1, 2001

Primary Completion

June 1, 2003

Last Updated

April 16, 2012

Record last verified: 2012-04

Locations

US(1)CA(1)NL(3)SL(2)GB(1)