|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
GlaxoSmithKline National Comprehensive Cancer Network |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01430572 |
Purpose
The goal of this clinical research study is to find the highest tolerable dose of the combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients with advanced cancer. The safety of these drugs will also be studied.
Pazopanib is designed to block different receptors in the cancer cells that ultimately are responsible for the growth of the tumor and its blood vessels.
Everolimus is designed to block a protein called mTOR inside the cancer cells, which is also involved in cancer growth.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers Solid Tumors |
Drug: Pazopanib Drug: Everolimus |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Combination of Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients With Advanced Solid Tumors Refractory to Standard Therapy |
| Estimated Enrollment: | 62 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pazopanib + Everolimus
Pazopanib 200 mg and Everolimus 5.0 mg oral dosing every other day (except for lead in 5 days of Cycle 1 where both drugs administered daily).
|
Drug: Pazopanib
Starting Dose: 200 mg by mouth on Days 1 - 5 of Cycle 1 only. On Day 6 and every cycle-day with an even number, only pazopanib administered.
Other Name: GW786034
Drug: Everolimus
Starting dose: 5.0 mg by mouth on Days 1 - 5 of Cycle 1. On Day 7 and every cycle-day with an odd number, only everolimus will be administered. Dose Expansion Phase: Maximum tolerated dose (MTD) from lead in phase. Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jennifer J. Wheler, MD | 713-745-9246 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Jennifer J. Wheler, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01430572 History of Changes |
| Other Study ID Numbers: | 2011-0322 |
| Study First Received: | September 6, 2011 |
| Last Updated: | April 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Advanced Cancers Solid Tumors PI3KCA Mutation Positive/PTEN Refractory to standard therapy Relapsed after standard therapy |
Pazopanib GW786034 Everolimus Afinitor RAD001 |
|
Neoplasms Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |