Ganetespib, Paclitaxel and Trastuzumab for MBC Her2+
Ganetespib, Paclitaxel and Trastuzumab for Advanced or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer
This study is currently recruiting participants. (see Contacts and Locations) Verified June 2014 by New York University School of Medicine Sponsor: New York University School of Medicine Collaborators: National Cancer Institute (NCI) Synta Pharmaceuticals Corp. Memorial Sloan-Kettering Cancer Center Information provided by (Responsible Party): New York University School of Medicine ClinicalTrials.gov Identifier: NCT02060253 First received: January 30, 2014 Last updated: June 4, 2014 Last verified: June 2014 History of Changes Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record Purpose This phase I trial studies the side effects and best dose of ganetespib when given with paclitaxel and trastuzumab in treating patients with advanced or metastatic human epidermal growth factor receptor 2 positive (HER2+) breast cancer. HER2+ describes cancer cells that have too much of a protein called HER2 on their surface. In normal cells, HER2 helps to control cell growth. When it is made in larger than normal amounts by cancer cells, the cells may grow more quickly and be more likely to spread to other parts of the body. Checking to see if a cancer is HER2+ may help plan treatment, which may include drugs that kill HER2+ cancer cells. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block the ability of tumors to grow and spread. Giving ganetespib with paclitaxel and trastuzumab may be an effective treatment for patients with HER2+ breast cancer. Condition Intervention Phase HER2-positive Breast Cancer Male Breast Cancer Recurrent Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Drug: ganetespib Drug: paclitaxel Biological: trastuzumab Phase 1 Study Type: Interventional Study Design: Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: A Phase I Clinical Trial of Ganetespib (Heat Shock Protein 90 Inhibitor) in Combination With Paclitaxel and Trastuzumab in Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Metastatic Breast Cancer Resource links provided by NLM: Genetics Home Reference related topics: breast cancer MedlinePlus related topics: Breast Cancer Cancer Male Breast Cancer Drug Information available for: Paclitaxel Urogastrone Trastuzumab Genetic and Rare Diseases Information Center resources: Breast Cancer, Male U.S. FDA Resources Further study details as provided by New York University School of Medicine: Primary Outcome Measures: Maximum tolerated dose (MTD) of ganetespib when combined with paclitaxel and trastuzumab [ Time Frame: 28 days ] [ Designated as safety issue: Yes ] Secondary Outcome Measures: Objective Response Rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ] Defined as the percentage of patients who have achieved complete response or partial response assessed based on Response evaluation criteria in solid tumors 1.1 (RECIST 1.1). Clinical benefit rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ] Defined as the percentage of patients who have achieved complete response, partial response, or stable disease for at least 24 weeks assessed based on RECIST 1.1. Duration of response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ] The duration of response is measured from the time of response to disease progression. Progression-free survival (PFS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ] The median time of progression-free survival will be calculated. Other Outcome Measures: PK parameters of paclitaxel (such as area under the curve and maximum concentration) [ Time Frame: Pre-dose, 0.5, 1, 1.5, 2, 4, 7, 21, 24, 27, and 31 hours ] [ Designated as safety issue: No ] Will be examined descriptively to evaluate the effect of ganetespib on the paclitaxel absorption. Estimated Enrollment: 18 Study Start Date: April 2014 Estimated Study Completion Date: September 2016 Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure) Arms Assigned Interventions Experimental: ganetespib, paclitaxel, and trastuzumab Patients receive trastuzumab IV over 30 minutes on days 1, 8, 15, and 22, paclitaxel IV over 1 hour on days 1, 8, 15, and 22, and ganetespib intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Drug: ganetespib Given IV Other Names: Hsp90 inhibitor STA-9090 STA-9090 Drug: paclitaxel Given IV Other Names: Anzatax Asotax TAX Taxol Biological: trastuzumab Given IV Other Names: anti-c-erB-2 Herceptin MOAB HER2 Detailed Description: PRIMARY OBJECTIVES: I. To establish the safety, tolerability, maximum tolerated dose (MTD) and the recommended phase II dose of ganetespib plus paclitaxel in conjunction with trastuzumab in patients with HER2+ metastatic breast cancer (MBC). SECONDARY OBJECTIVES: I. To evaluate the possible effects of ganetespib on the pharmacokinetics (PK) of paclitaxel. II. To make a preliminary assessment of the efficacy of the combination of ganetespib, paclitaxel and trastuzumab as measured by objective response rate (ORR), progression-free survival (PFS), duration of response, and clinical benefit rate (complete response + partial response + stable disease > 24 weeks). OUTLINE: Patients receive trastuzumab IV over 30 minutes on days 1, 8, 15, and 22, paclitaxel IV over 1 hour on days 1, 8, 15, and 22, and ganetespib intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 12 weeks. Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No |
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