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Clinical Trials/DRKS00003301
DRKS00003301
Not yet recruiting
Phase 2

A phase II trial to evaluate safety and efficacy of combined trastuzumab and AUY922 in advanced non-small cell lung cancer (NSCLC) with HER2 - overexpression or -amplification or - mutation. - TRY

niversität Köln0 sites29 target enrollmentNovember 2, 2012
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ConditionsHER2-overexpression or -amplification or -mutationC34Malignant neoplasm of bronchus and lung

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
HER2-overexpression or -amplification or -mutation
Sponsor
niversität Köln
Enrollment
29
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 2, 2012
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversität Köln

Eligibility Criteria

Inclusion Criteria

  • •Stage IV NSCLC patients after failure of at least one standard therapy with HER2 protein overexpression or gene amplification (FISH\-positive) or mutation
  • •Age \> 18 years
  • •ECOG performance status 0 to 2
  • •Life expectancy of at least 12 weeks
  • •Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
  • •Adequate bone marrow, liver and renal function and adequate electrolyte balance as assessed by
  • •following laboratory requirements conducted 14 days prior to treatment:
  • •Hemoglobin \= 9\.0 g/dL
  • •Absolute neutrophil count (ANC) \= 1500 /mm3
  • •Platelet count \= 100,000/µL

Exclusion Criteria

  • •Known hypersensitivity to any study medication
  • •Other history of ongoing malignancy that would potentially interfere with the interpretation of efficacy
  • •Previous treatment with Hsp90 inhibitors (e.g.17\-AAG)
  • •Treatment with therapeutic doses of coumarin derivatives..Low doses of coumarin derivatives (e.g. \< 2mg/day) are permitted
  • •Pregnant or lactating women
  • •Patients with concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes mellitus, active untreated of uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause) that could cause unacceptable safety risks or compromise compliance with the protocol
  • •Impaired cardiac function including any of the following:
  • •oHistory (or family history) of long QT syndrome
  • •oMean QTcF \= 450 msec on screening ECG
  • •oHistory of clinically manifested ischemic heart disease \= 6 months prior to study start

Outcomes

Primary Outcomes

Not specified

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