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Oral Deforolimus With Trastuzumab for Patients With HER2-Positive Trastuzumab-Refractory Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by Ariad Pharmaceuticals, May 2009
First Received: August 14, 2008   Last Updated: May 29, 2009   History of Changes
Sponsors and Collaborators: Ariad Pharmaceuticals
Merck
Information provided by: Ariad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00736970
  Purpose

This clinical trial will study the use of deforolimus in metastatic breast cancer subjects whose tumors have shown a resistance to trastuzumab (herceptin). The goal of this study is to find out if subjects treated with deforolimus in combination with trastuzumab have a positive response to the treatment, and if treatment with deforolimus in combination with trastuzumab prolongs survival.


Condition Intervention Phase
Breast Cancer
Breast Neoplasms
Drug: ridaforolimus
Drug: trastuzumab
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title: A Phase II Trial of Oral Deforolimus (AP23573; MK-8669), an mTOR Inhibitor, in Combination With Trastuzumab for Patients With HER2-Positive Trastuzumab-Refractory Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Ariad Pharmaceuticals:

Primary Outcome Measures:
  • Objective Response Rate (ORR) measured by modified RECIST guidelines [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: July 2008
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: ridaforolimus
10 mg oral tablets administered at 40 mg once daily for 5 consecutive days each week, followed by 2 days without deforolimus.
Drug: trastuzumab
single intravenous infusion every week; initial dose of 4 mg/kg over 90 minutes, then 2 mg/kg over 30 minutes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female, 18 years of age or older
  • Histologically confirmed HER2-positive metastatic breast cancer
  • Trastuzumab-resistance
  • Measurable disease, according to RECIST guidelines
  • ECOG performance status less than or equal to 1
  • Life expectancy greater than 3 months
  • No prior treatment with temsirolimus, everolimus, rapamycin, or any other mTOR inhibitor
  • At least 4 weeks must have lapsed between prior investigational therapy, chemotherapy or radiotherapy, and the first dose of deforolimus
  • Left ventricular ejection greater than or equal to 50%
  • Adequate cardiovascular function
  • Adequate hematological, hepatic, and renal function
  • Serum cholesterol less than or equal to 350 mg/dL and triglycerides less than or equal to 400 mg/dL
  • Negative pregnancy test within 7 days prior to first dose of study drug and must use an approved contraceptive method from screening to 30 days after the last dose of study drug
  • Availability and patient consent to obtain archival tissue samples
  • Signed informed consent

Exclusion Criteria:

  • Inadequate recovery from any prior surgical procedure or having undergone any major surgery within 2 weeks before trial entry
  • Grade 1 or Grade 2 hypersensitivity reactions to prior trastuzumab therapy if these reactions prevented further trastuzumab administration
  • Grade 3 or Grade 4 hypersensitivity reaction to prior trastuzumab
  • Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest
  • Known allergy to macrolide antibiotics
  • Pregnant or breast-feeding
  • Know history of HIV
  • Diagnosis of brain metastasis or leptomeningeal carcinomatosis within 3 months
  • Other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
  • Active infection requiring prescription intervention
  • Newly diagnosed or poorly controlled Type 1 or 2 diabetes
  • Other concurrent illness which, in the Investigator's judgment, would either compromise the patient's safety or interfere with the evaluation of the safety of the study drug
  • Concurrent treatment with medications that strongly induce or inhibit cytochrome P450.
  • Any condition that renders patient unable to fully understand and provide informed consent and/or comply with the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736970

Contacts
Contact: Frank Haluska, MD, PhD 617-494-0400 Frank.Haluska@ariad.com

Locations
United States, Florida
ARIAD Investigational Site #111 Recruiting
Fort Myers, Florida, United States, 33916
United States, Illinois
ARIAD Investigational Site #109 Recruiting
Maryville, Illinois, United States, 62062
United States, Louisiana
ARIAD Investigational Site #035 Recruiting
Metairie, Louisiana, United States, 70006
United States, Tennessee
ARIAD Investigational Site #076 Recruiting
Nashville, Tennessee, United States, 37203
ARIAD Investigational Site #112 Recruiting
Chattanooga, Tennessee, United States, 37404
United States, Texas
ARIAD Investigational Site #106 Withdrawn
Dallas, Texas, United States, 75231
ARIAD Investigational Site #113 Recruiting
Abilene, Texas, United States, 79606
United States, Virginia
ARIAD Investigational Site #069 Recruiting
Richmond, Virginia, United States, 23230
Chile
ARIAD Investigational Site #823, Instituto Clinico Oncologico del Sur (ICOS) Recruiting
Temuco, Chile, 01745
Czech Republic
ARIAD Investigational Site #771, Fakultni nemocnice Olomouc Recruiting
Olomouc, Czech Republic, 77520
ARIAD Investigational Site #717, Masarykuv onkogicky ustav Recruiting
Brno, Czech Republic, 65653
ARIAD Investigational Site #770, Fakulni nemocnice Na Bulovce Recruiting
Praha 8, Czech Republic, 18001
France, Ile-de-France
ARIAD Investigational Site #781, Institut Curie Recruiting
Paris, Ile-de-France, France, 75005
France, Rhone-Alps
ARIAD Investigational Site #746, Centre Leon Berard Recruiting
Lyon, Rhone-Alps, France, 69373
Sponsors and Collaborators
Ariad Pharmaceuticals
Merck
Investigators
Study Director: Frank Haluska, MD, PhD Ariad Pharmaceuticals
  More Information

No publications provided

Responsible Party: ARIAD Pharmacueticals, Inc. ( Frank Haluska, MD, PhD, VP, Clinical Research )
Study ID Numbers: AP23573-08-207
Study First Received: August 14, 2008
Last Updated: May 29, 2009
ClinicalTrials.gov Identifier: NCT00736970     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Ariad Pharmaceuticals:
deforolimus
AP23573
breast cancer

Study placed in the following topic categories:
Skin Diseases
Trastuzumab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Trastuzumab
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009