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

NCT00773344 | Completed Phase 1

• 2 other identifiers: CA200-001KAG 122
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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

Conditions

Solid Tumors; Breast Cancer

Keywords

Solid Tumors (dose escalation/Phase 1); Breast Cancer (recommended dose phase/Phase 2)

Outcome Measures

Primary Outcomes (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 Outcomes (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)

  3-6 months

• 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

• 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

Study Arms (1)

A1

EXPERIMENTAL

Drug: Tanespimycin

Interventions

Tanespimycin DRUG

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)

Also known as: BMS-722782

A1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 10\*9\* /L
• Platelet count \>= 75 x 10\*9\* /L
• Serum bilirubin \<= 2 x ULN
• AST and ALT \<= 2 x ULN
• Serum creatinine \<= 2 x ULN
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Premiere Oncology Of Arizona

Scottsdale, Arizona, 85260, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: December 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: November 4, 2015

Record last verified: 2015-10

Locations

US (3)