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Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors

A Phase I/II, Open-Label, Multicenter, Two-Arm, Feasibility Study of Pazopanib, Carboplatin, and Paclitaxel in Women With Newly Diagnosed, Previously Untreated, Gynaecological Tumors

NCT00561795•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is an open-label, two-arm, multicenter feasibility study to evaluate the safety and tolerability of pazopanib in combination with carboplatin and paclitaxel in female subjects with newly diagnosed advanced gynaecological tumors. Subjects will have received no prior therapy for their disease. A minimum of 12 and a maximum of 46 subjects will be enrolled. Dose schemas for each study arm are described in the protocol. For each arm, six subjects will be evaluated in treatment cohorts, which will be expanded to 20 subjects if initial toxicity is acceptable. Overall safety and tolerability of the regimen will be based on dose limiting toxicities, adverse events, and percentage of subjects that complete 6 courses of study treatment. Antitumor activity will be assessed using RECIST criteria and cancer antigen 125 (CA-125) responses.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•A subject will be considered eligible for inclusion in this study only if all of the following criteria are met:
•Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up.
•Procedures conducted as a part of routine clinical management of the subject (e.g., blood count, imaging study) and obtained prior to signed informed consent may be utilized for Screening or Baseline purposes provided these tests are obtained as specified in the protocol).
•Female subjects ≥18 years of age with newly diagnosed advanced gynaecological malignancies for whom carboplatin and paclitaxel based chemotherapy is indicated. Patients may have surgery to debulk or resect disease but may not have received chemotherapy or radiotherapy.
•Histological confirmation of the following: epithelial ovarian cancer, endometrial carcinoma, uterine sarcoma, mixed Müllerian tumour, fallopian tube carcinoma, primary peritoneal carcinoma, cervical carcinoma or vulvar carcinoma.
•Performance status must be ECOG 0 1.
•Adequate organ system function as defined in Table 6
•Table 6 Definitions for Adequate Organ Function
•System (Laboratory Values)
•Hematologic:
+33 more criteria

Exclusion Criteria

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•Prior use of anticancer therapy (except cytoreductive surgery \[debulking\]) for their cancer.
•Presence of bulky, residual, squamous cell tumors.
•Is unable to discontinue prohibited medications, as listed in Section 8.2 for 14 days or five half-lives of a drug prior to Visit 1 and for the duration of the study.
•Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including but not limited to:
•Malabsorption syndrome
•Major resection of the stomach or small bowel that could affect the absorption of study drug
•Active peptic ulcer disease
•Inflammatory bowel disease
•Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation
+15 more criteria

Locations (5)

GSK Investigational Site

Lyon, France

GSK Investigational Site

Strasbourg, France

GSK Investigational Site

Marburg, Hesse, Germany

GSK Investigational Site

Wiesbaden, Hesse, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

Key Dates

Start Date

September 1, 2007

Primary Completion Date

April 1, 2008

Completion Date

April 1, 2008

Last Updated

March 22, 2012

Enrollment

ACTUAL participants

Conditions

Primary Peritoneal CarcinomaTumorEpithelial Ovarian CancerUterine DiseaseCervix DiseasesNeoplasms, OvarianCancer

Interventions

pazopanib (GW786034)

DRUG

carboplatin

DRUG

paclitaxel

DRUG

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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: March 22, 2012Data 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.

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Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors

Inclusion Criteria

Exclusion Criteria

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