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Sponsors and Collaborators: |
Accelerated Community Oncology Research Network GlaxoSmithKline |
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Information provided by: | Accelerated Community Oncology Research Network |
ClinicalTrials.gov Identifier: | NCT00800345 |
This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors.
Condition | Intervention | Phase |
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Gynecologic Tumors |
Drug: Oral Topotecan Drug: Pazopanib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase I Trial of Oral Metronomic Topotecan in Combination With Oral Pazopanib Utilizing a Daily Dosing Schedule to Treat Recurrent or Persistent Gynecologic Tumors |
Estimated Enrollment: | 20 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Experimenal: Experimental
Metronomic oral topotecan and oral pazopanib will be administered by mouth once daily beginning on day 1. The 1st 3 patients enrolled receiving oral topotecan 0.50 mg QD and oral pazopanib 400 mg QD. 3 patients will be enrolled at dose level 1 and observed for DLT(s) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s).
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Drug: Oral Topotecan
Starting on Day 1, each subject will receive the assigned dose of topotecan administered once daily by mouth.
Drug: Pazopanib
Starting on Day 1, each subject will receive the assigned dose of pazopanib administered once daily by mouth.
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This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors. The study will include a Screening Phase, a Treatment Phase and a Followup Phase. In the Screening Phase the subject's eligibility for study participation will be determined; this phase can last up to 28 days. The Treatment Phase will begin when the subject starts study treatment and will continue until the subject is removed from study treatment.
The Follow-up Phase will last for 30 days after the subject ends study treatment. The study will be conducted at approximately 1 Accelerated Community Oncology Research Network, Inc.(ACORN) site and will include approximately 9-20 evaluable patients. Treatment cycle length is 28 days. During cycle 1, patients will have assessments done on days 1, 8, and 15. During cycle 2, patients will have assessments done on days 1 and 15. In cycle 3 and thereafter the patient is only required to have assessments done on day 1. The patient may be evaluated more frequently as needed to manage toxicities or per investigator discretion. Radiologic imaging will be repeated after every 2 cycles.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, liver and renal function at study entry as assessed by the following:
Exclusion Criteria:
Inability to swallow a capsule or clinically significant gastrointestinal abnormalities including, but not limited to:
History of any one or more of the following cardiovascular conditions within the past 6 months:
Contact: Amanda Johns, RHIA,CCRP | (901) 435-5578 | ajohns@sosacorn.com |
Contact: Cindy Lee, RN,MSN,CCRP | (901) 259-8282 | clee@sosacorn.com |
United States, Tennessee | |
The West Clinic | |
Memphis, Tennessee, United States, 38120 |
Principal Investigator: | Todd D Tillmanns, MD | The West Clinic |
Responsible Party: | Accelerated Community Oncology Research Network, Inc. ( Amanda Johns,RHIA,CCRP ) |
Study ID Numbers: | ATDTRPST0802 |
Study First Received: | December 1, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00800345 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Gynecologic tumors |
Genital Neoplasms, Female Urogenital Neoplasms Topotecan Recurrence |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Genital Neoplasms, Female Enzyme Inhibitors Urogenital Neoplasms Topotecan Pharmacologic Actions |