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EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

Primary Purpose

Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
epothilone b
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring ovarian, ovary, peritoneal cancer, fallopian cancer, cancer, tumor, tumour, neoplasm, carcinoma, intravenous, epothilone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EPO906

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to disease progression
Overall survival
Duration of response
duration of response in patients with complete response (CR) or partial response (PR)
recording all adverse events (AEs) and serious adverse events (SAEs)
Safety and tolerability of patupilone by monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry and urine lalues, vital signs, ECG and physical examinations
pharmacogenetic analyses with blood and tumor samples from these patients

Full Information

First Posted
May 2, 2002
Last Updated
April 13, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00035100
Brief Title
EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
Official Title
An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
Keywords
ovarian, ovary, peritoneal cancer, fallopian cancer, cancer, tumor, tumour, neoplasm, carcinoma, intravenous, epothilone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPO906
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
epothilone b
Other Intervention Name(s)
EPO906
Primary Outcome Measure Information:
Title
Tumor response rate
Description
tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame
Every 2 cycles
Secondary Outcome Measure Information:
Title
Time to disease progression
Time Frame
from start of treatment to documented disease progression, death from study indication, or the date of last follow-up
Title
Overall survival
Time Frame
measured from the start of treatment to the date of death or the last date the patient was known to be alive.
Title
Duration of response
Description
duration of response in patients with complete response (CR) or partial response (PR)
Time Frame
Every 3 months
Title
recording all adverse events (AEs) and serious adverse events (SAEs)
Description
Safety and tolerability of patupilone by monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry and urine lalues, vital signs, ECG and physical examinations
Time Frame
Every 3 months
Title
pharmacogenetic analyses with blood and tumor samples from these patients
Time Frame
Every 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
812 50
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Kosice
ZIP/Postal Code
04190
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

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EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer

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