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Sponsors and Collaborators: |
Sarah Cannon Research Institute SCRI Oncology Research Consortium Novartis |
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Information provided by: | Sarah Cannon Research Institute |
ClinicalTrials.gov Identifier: | NCT00556088 |
This phase I protocol will evaluate the safety and tolerability of the combination of LBH589 and paclitaxel/carboplatin. The combination of LBH589, paclitaxel/carboplatin, and bevacizumab will also be evaluated for tolerability and preliminary antitumor activity in a subset of patients with advanced non-small cell lung cancer.
Condition | Intervention | Phase |
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Solid Tumors |
Drug: LBH589, Paclitaxel, Carboplatin, Bevacizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of LBH589 in Combination With Paclitaxel and Carboplatin +/- Bevacizumab the Treatment of Solid Tumors |
Estimated Enrollment: | 40 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Part 1: Experimental
Part I Phase I dose escalation trial. LBH589 will be administered orally on Monday and Thursday or Tuesday and Friday each week (twice weekly). Paclitaxel and carboplatin will be administered intravenously every 21 days. Part II LBH589, paclitaxel, and carboplatin dosing will be determined in the first phase of this study (Phase I). The drug dosages to be administered will be reduced one level from the determined Maximum Tolerated Dose (MTD). In addition, bevacizumab 15 mg/kg will be added to the second portion of this trial. |
Drug: LBH589, Paclitaxel, Carboplatin, Bevacizumab
LBH589 will be administered orally twice weekly. Paclitaxel and carboplatin will be administered intravenously every 21 days. Once the MTD is established, drug dosages will be adjusted downward by one dose level and bevacizumab 15mg/kg intravenously every 3 weeks will be administered to a subset of patients with non-small cell lung cancer. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory values as follows:
ANC >= 1500/μL Hgb >= 9 g/dL Platelets >= 100,000/uL Bilirubin <= upper limit normal (ULN) AST/SGOT and ALT/SGPT <= 2.5 x ULN or <= 5.0 x ULN in patients with liver metastases Creatinine <= 2.0 mg/dL Or 24-hour Creatinine Clearance >= 50 ml/min Albumin >= 3 g/dL Potassium >= lower limit normal (LLN) Phosphorous >= LLN Calcium >= LLN Magnesium >= LLN PT/INR and PTT <= 1.5 x ULN
Exclusion Criteria:
Impaired cardiac function including any of the following:
Exclusion Criteria (Part II portion)
Patients with proteinuria at screening for as demonstrated by either:
a. Urine protein creatinine (UPC) ration >1.0 at screening OR b. Urine dipstick for proteinuria > 2+ (patients discovered to have > 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate < 1 g of protein in 24 hours to be eligible.
United States, Tennessee | |
Tennessee Oncology, PLLC | |
Nashville, Tennessee, United States, 37023 |
Study Chair: | Howard A. Burris, M.D. | SCRI Oncology Research Consortium |
Responsible Party: | Sarah Cannon Research Institute ( Howard A. Burris, III, M.D. ) |
Study ID Numbers: | SCRI REFMAL 121 |
Study First Received: | November 8, 2007 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00556088 |
Health Authority: | United States: Food and Drug Administration |
LBH589 Phase I Solid Tumors Paclitaxel |
Carboplatin Bevacizumab Dose escalation |
Paclitaxel Carboplatin Bevacizumab |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Mitosis Modulators Physiological Effects of Drugs Antimitotic Agents Angiogenesis Inhibitors |
Pharmacologic Actions Therapeutic Uses Tubulin Modulators Angiogenesis Modulating Agents Growth Inhibitors Antineoplastic Agents, Phytogenic |