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Sponsors and Collaborators: |
Duke University Novartis Genentech Amgen |
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00586443 |
Targeting molecular pathways of tumor growth has become a major focus of anti-cancer treatments. This study aims to investigate the toxicity, pharmacokinetics, and preliminary efficacy of the triplet combination of bevacizumab, RAD001, and panitumumab in patients with refractory solid tumors.
This open-labeled, non-randomized phase I trial of bevacizumab, everolimus and panitumumab is designed to assess the safety, tolerability and efficacy of this combination in adult patients with advanced solid tumors.
Condition | Intervention | Phase |
Solid Tumors |
Drug: bevacizumab, everolimus, panitumumab |
Phase I |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Bevacizumab Everolimus Panitumumab |
Study Type: | Interventional |
Study Design: | Other, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of Bevacizumab, Everolimus, and Panitumumab for Patients With Advanced Solid Tumors |
Estimated Enrollment: | 44 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
I
This is a Phase I safety study. There is only one arm.
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Drug: bevacizumab, everolimus, panitumumab
Cohort # subjects Bevacizumab Everolimus Panitumumab
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Show Detailed Description |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ and marrow function as defined below:
**Absolute neutrophil count greater or equal to 1,500/μl; Platelets greater or equal to 100,000/μl; Total bilirubin, less or equal to 1.5 X upper limit of normal (ULN)AST(SGOT)/ALT(SGPT)less or equal to 2.5 X ULN less or equal to 5 X ULN if known hepatic metastases; Creatinine clearance greater or equal to 50 mL/min/m2 for patients with creatinine levels (by Cockroft-Gault equation or 24 hour urine; Hemoglobin > 9 g/dL; Magnesium > 1.2 mg/dL; Calcium (corrected for albumin)> 8.7 mg/dL
Exclusion Criteria:
Contact: ASK DUKE | 888.275.3853 | |
Contact: Shawna Savage, RN | 919.684.6342 |
United States, North Carolina | |||||
Duke University Medical Center | Recruiting | ||||
Durham, North Carolina, United States, 27710 | |||||
Principal Investigator: Herbert I Hurwitz, MD |
Duke University |
Novartis |
Genentech |
Amgen |
Principal Investigator: | Herbert I Hurwitz, MD | Duke University |
Responsible Party: | Duke University Medical Center, Department of Medicine/Oncology ( Herbert Hurwitz, MD ) |
Study ID Numbers: | 1082 |
First Received: | December 21, 2007 |
Last Updated: | August 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00586443 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
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