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Pazopanib and Weekly Topotecan in Patients Recurrent Ovarian Cancer (TOPAZ) | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

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

A Phase I/II Study of Pazopanib and Weekly Topotecan in Patients With Platinum-resistant or Intermediate-sensitive Recurrent Ovarian Cancer

NCT01600573•JSehouli

View on ClinicalTrials.gov

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

Detailed Description

This study is a prospective single-arm, open-label, multicenter phase I/II trial. The phase I-trial is a dose-escalation trial to determine the maximum tolerated dose (MTD) of pazopanib in combination with weekly topotecan. The phase II-trial is a single arm open-label trial to further assess the safety and the efficacy of this combination of treatment.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•written informed consent
•histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube cancer
•platinum resistant (recurrence within 6 months of a platinum-containing regimen) or platinum refractory (progression during platinum treatment) or intermediate platinum-sensitive (recurrence within 12 months after a platinum-based primary therapy) disease
•no more than 2 prior treatment regimens for epithelial ovarian cancer
•Age more than 18 years
•ECOG of 0 or 1
•adequate organ function
•measurable disease or evaluable disease according to RECIST criteria
•able to swallow and retain oral medication
•life expectancy of at least 12 weeks
+1 more criteria

Exclusion Criteria

•prior malignancies; subject who have had another malignancy and have been disease-free for 5 years which effect progression free survival, or subject with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible
•History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases.
•clinically significant gastrointestinal abnormalities that might interfere with oral dosing or that may increase the risk for gastrointestinal bleeding
•clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
•Grade 3 or 4 diarrhoea
•Any unstable or serious concurrent condition (e.g., active infection requiring systemic therapy)
•poorly controlled hypertension \[defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg\]
•Prolongation of corrected QT interval (QTc) \>450 milliseconds using Bazett's formula
•History of any one or more of the following cardiovascular conditions within the past 6 months: Cardiac angioplasty or stenting; myocardial infarction; unstable angina; symptomatic peripheral vascular disease; coronary artery by-pass graft surgery
•Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA)
+18 more criteria

Locations (1)

Charité Campus Virchow-Klinikum

Berlin, Germany

Key Dates

Start Date

May 1, 2012

Primary Completion Date

March 1, 2017

Completion Date

March 1, 2017

Last Updated

October 11, 2016

Enrollment

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

pazopanib in combination with weekly topotecan

DRUG

Contacts

Jalid Sehouli, Prof. Dr.

CONTACT

+49 (0) 30 450 jalid.sehouli@charite.de

Radoslav Chekerov, Dr.

CONTACT

030/450 radoslav.chekerov@charite.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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