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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00035100
Other study ID # CEPO906A2203
Secondary ID
Status Completed
Phase Phase 2
First received May 2, 2002
Last updated April 13, 2012
Start date September 2001

Study information

Verified date April 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
epothilone b


Locations

Country Name City State
Canada Novartis Investigative Site Toronto Ontario
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Enschede
Netherlands Novartis Investigative Site Zwolle
Slovakia Novartis Investigative Site Bratislava
Slovakia Novartis Investigative Site Kosice
United Kingdom Novartis Investigative Site Surrey
United States Novartis Investigative Site New Brunswick New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Netherlands,  Slovakia,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor response rate tumor response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Every 2 cycles No
Secondary Time to disease progression from start of treatment to documented disease progression, death from study indication, or the date of last follow-up No
Secondary Overall survival measured from the start of treatment to the date of death or the last date the patient was known to be alive. No
Secondary Duration of response duration of response in patients with complete response (CR) or partial response (PR) Every 3 months No
Secondary 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 Every 3 months Yes
Secondary pharmacogenetic analyses with blood and tumor samples from these patients Every 3 months Yes
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