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Pazopanib and Weekly Topotecan in Patients Recurrent Ovarian Cancer (TOPAZ)

NCT01600573 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2016-10-11

No results posted yet for this study

Summary

This clinical trial shall clarify the efficacy and safety of pazopanib in combination with weekly topotecan in patients with platinum-resistant or intermediate platinum-sensitive recurrent epithelial ovarian cancer, fallopian and peritoneal carcinoma

Conditions

Interventions

DRUG

pazopanib in combination with weekly topotecan

* Topotecan as an IV infusion over 30 minutes on days 1, 8, and 15 of a 28 day cycle and * Pazopanib orally once daily continuous dosing in the following dose levels: Phase I Trial: Dose level -I: Topotecan weekly 3mg/m2, Pazopanib 400 mg Dose level I: Topotecan weekly 4mg/m2, Pazopanib 400 mg Dose level II: Topotecan weekly 4mg/m2, Pazopanib 600 mg Dose level III: Topotecan weekly 4mg/m2, Pazopanib 800 mg Phase II Trial: Phase II will either use the MTD as determined in Phase I or a lower dose if deemed necessary.

Sponsors & Collaborators

Principal Investigators

  • jalid Sehouli, Prof. Dr. · Charite University, Berlin, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01600573 on ClinicalTrials.gov