Temsirolimus and Pazopanib in Patients With Advanced Solid Tumors
NCT01072890
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- Must have histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
- Age ≥ 18 years old
- Zubrod (ECOG) Performance Status 0 - 2
- May have measurable or non-measurable disease.
- Adequate bone marrow and organ function as assessed by the following within 14 days prior to registration.
- Any number of prior chemotherapy regimens is allowed.
- Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol and all side effects (except alopecia, lymphopenia and hyperglycemia) resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy.
- Pregnant or nursing women are ineligible because of the risk to the fetus. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent.
- Ability to swallow and retain oral medications.
- Prior treatment with an mTOR inhibitor or pazopanib.
- Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have
unstable angina (anginal symptoms at rest) or new onset angina (began within the last
3 months) or myocardial infarction within the past 6 months.
- Symptomatic or uncontrolled brain metastasis.
- Must have a EKG within 14 days of registration and a QTc of < 480 msec. If the initial
QTc is > 480 msec, two subsequent EKGs should be obtained within 5 minutes.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
pressure > 90 mmHg, despite optimal medical management.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C due to
the immunosuppressive effects of temsirolimus.
- Active clinically serious infection > CTCAE Grade 2.
- Fasting cholesterol > 350mg/dL and fasting triglycerides > 400mg/dL
- Thrombolic or embolic events such as a cerebrovascular accident including transient
ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of
study drug.
- Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of
study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or coagulopathy. Therapeutic anticoagulation
with warfarin, heparin or low molecular weight heparin is not allowed. Patients may
not have had an arterial thrombotic event within the past 6 months.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
dose of study drug.
- May not take known strong CYP3A4 inducers such as rifampin or St. John's wort or
strong CYP3A4 inhibitors such as ketoconazole, diltiazem, or verapamil.
- Known or suspected allergy to temsirolimus or pazopanib, any similar agents such as
the rapamycin analog sirolimus, or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow whole pills.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- St. Louis, Missouri
- Sacramento, California
- Chicago, Illinois
- Birmingham, Alabama
- Birmingham, Alabama
- Birmingham, Alabama
- Los Angeles, California
- Los Angeles, California
- San Francisco, California
- San Francisco, California
- Santa Monica,, California
- Aurora, Colorado
- Indianapolis, Indiana
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Ann Arbor, Michigan
- Detroit, Michigan
- Farmington Hills, Michigan
- Minneapolis, Minnesota
- St. Louis, Missouri
- Albuquerque, New Mexico
- Albuqurque, New Mexico
- New York, New York
- New York, New York
- New York, New York
- Durham, North Carolina
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Myrtle Beach, South Carolina
- Franklin, Tennessee
- Gallatin, Tennessee
- Hermitage, Tennessee
- Lebanon, Tennessee
- Murfreesboro, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Smyrna, Tennessee
- Dallas, Texas
- Houston, Texas
- Madison, Wisconsin
- Randwick, New South Wales
- East Melbourne, Victoria
- Heidelberg, Victoria
- Montreal, Quebec
- Villejuif Cedex,
- Thessaloniki,
- Milano,
- Milano,
- Nijmegen, Gld
- Singapore,
- Lund,
- Stockholm,
- St. Gallen,
- Leeds,
- London,
- London,
- Newcastle-Upon-Tyne,
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Temsirolimus and Pazopanib in Patients With Advanced Solid Tumors | |||
| Official Title ICMJE | Phase I Study of the Combination of Temsirolimus (CCI-779) and Pazopanib (GW786034) in Patients With Advanced Solid Tumors | |||
| Brief Summary | The purpose of this study is to test the safety of temsirolimus and pazopanib at different doses. Patients who have an advanced cancer that is not felt to benefit from standard treatment or are no longer responding to other treatment will be asked to take part in this study. The study hypothesis is that temsirolimus and pazopanib can be administered safely in combination and that combined targeting of the mammalian target of rapamycin (mTOR) and vascular endothelial growth factor receptor (VEGFR) signaling pathways will be effective in treating patients with advanced solid tumors. | |||
| Detailed Description | Despite encouraging clinical activity reported with single-agent VEGF inhibitors, mTOR inhibitors, and other novel agents, patients rarely achieve complete disease response and ultimately undergo disease progression. The limited efficacy of single-target inhibition may be due to numerous, overlapping signaling pathways involved in Renal Cell Carcinoma proliferation and growth. A strategy of multi-target "vertical inhibition" of the overlapping aberrant VEGF and mTOR pathways by combination therapy may translate to enhanced efficacy over each single agent alone. We hypothesize that temsirolimus and pazopanib can be administered safely in combination and that combined targeting of the mTOR and VEGFR signaling pathways will be effective in treating patients with advanced solid tumors. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Solid Tumors | |||
| Intervention ICMJE | Drug: Temsirolimus, Pazopanib
Patients will be treated on an outpatient basis with both temsirolimus and pazopanib. All patients will receive temsirolimus intravenously (IV) weekly days 1, 8, 15, and 22. Patients will receive oral pazopanib on a daily basis starting day 1. Treatment will be administered on 28 day cycles. Patients will be in this study for a minimum of 8 weeks or 2 cycles. Other Names:
| |||
| Study Arms ICMJE | Experimental: Temsirolimus and Pazopanib
Intervention: Drug: Temsirolimus, Pazopanib | |||
| Publications * | Semrad TJ, Eddings C, Dutia MP, Christensen S, Lara PN Jr. Phase I study of the combination of temsirolimus and pazopanib in advanced solid tumors. Anticancer Drugs. 2013 Jul;24(6):636-40. doi: 10.1097/CAD.0b013e3283618b7b. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 8 | |||
| Original Estimated Enrollment ICMJE | 30 | |||
| Actual Study Completion Date ICMJE | February 2012 | |||
| Actual Primary Completion Date | February 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01072890 | |||
| Other Study ID Numbers ICMJE | 200917514 UCDCC#222 ( Other Identifier: University of California Davis ) | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | University of California, Davis | |||
| Study Sponsor ICMJE | University of California, Davis | |||
| Collaborators ICMJE |
| |||
| Investigators ICMJE |
| |||
| PRS Account | University of California, Davis | |||
| Verification Date | March 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||