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Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin in Patients With Solid Tumors and Her2 Positive Metastatic Breast Cancer That Have Previously Failed Herceptin

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00773344
Collaborator
(none)
25
Enrollment
3
Locations
1
Arm
44
Duration (Months)
8.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not previously responded to Herceptin

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 1/2 Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
May 1, 2009
Actual Study Completion Date :
Aug 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: A1

Drug: Tanespimycin
Solution, IV, Weekly two hour infusion, 4-cycles until disease progression or DLT This is a one-arm study with 4 fixed doses of Tanespimycin (225mg/m2, 300mg/m2, 375mg/m2 and 400mg/m2)
Other Names:
  • BMS-722782

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective tumor response rate (RECIST complete response, or partial response ) confirmed by CT and MRI as the preferred methods for tumor assessments and Chest x-ray is acceptable for pulmonary lesions [Within 28 days prior to the start of treatment with tumor assessments reevaluated every 8 weeks (+/- 4 days)]

    Secondary Outcome Measures

    1. Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival) [3-6 months]

    2. Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival) [6-12 months]

    3. Kaplan-Meier estimates duration of response and time-to-event variables will be used (time to progression, progression-free survival, time to response, duration of response, time to treatment failure and overall survival) [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age >=18 years

    • KPS performance status >= 70%

    • For the Phase 1 portion of the trial, all patients must have a histologically confirmed solid tumor malignancy. For the Phase 2 portion of the trial, patients must have metastatic breast cancer with HER2 amplification by FISH or 3+ HER2 overexpression by immunohistochemistry ("IHC") Patients may have had either progressive disease within 3 months following last dose of adjuvant treatment with trastuzumab OR progressive disease following initial therapy for metastatic disease with trastuzumab (trastuzumab may have been administered with cytotoxic chemotherapy, hormonal therapy or as single agent.) Patients who have received trastuzumab single agent therapy (without documented progressive disease) followed by trastuzumab combination therapy remain eligible for this study at the time of disease progression. Patients must have measurable disease by RECIST

    • All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade <= 2 (except for alopecia)

    • The following laboratory results, within 10 days of KOS-953 administration:

    • Hemoglobin >= 8.5 g/dL

    • Absolute neutrophils count >= 1.5 x 109 /L

    • Platelet count >= 75 x 109 /L

    • Serum bilirubin <= 2 x ULN

    • AST and ALT <= 2 x ULN

    • Serum creatinine <= 2 x ULN

    • Signed informed consent

    Exclusion Criteria:

    • Documented hypersensitivity reaction of CTCAE Grade >= 3 to prior therapy containing Cremophor (for those patients who receive the Tanespimycin Injection only) or Herceptin

    • Pregnant or breast-feeding women

    • Known active CNS metastases

    • Except for trastuzumab (Herceptin®) administered between 7-21 days prior to first tanespimycin (KOS-953) administration, administration of any other chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 14 days prior to receipt of study medication. Patients should be 6 weeks from last dose of nitrosourea

    • Severe dyspnea at rest caused by complications of advanced malignancy or requiring supplementary oxygen therapy

    • Congestive heart failure, or a left ventricular ejection fraction (LVEF) less than 50% assessed by multigated radionuclide angiography scan or echocardiography

    • Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient

    • Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin, carcinoma-in-situ of either the uterine cervix or urinary bladder, or Stage T1 or T2 prostate cancer whose PSA is < 2 ng/mL

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Premiere Oncology Of Arizona Scottsdale Arizona United States 85260
    2 Arizona Cancer Center Tucson Arizona United States 85724
    3 Memorial Sloan-Kettering Cancer Center New York New York United States 10021

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00773344
    Other Study ID Numbers:
    • CA200-001
    • KAG 122
    First Posted:
    Oct 16, 2008
    Last Update Posted:
    Nov 4, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Bristol-Myers Squibb
    Solid Tumors (dose escalation/Phase 1)
    Breast Cancer (recommended dose phase/Phase 2)
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Nov 4, 2015