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Old 11-16-2014, 10:53 AM   #1
'lizbeth
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Post 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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