EUCTR2011-005655-13-DE
Active, not recruiting
Phase 1
A phase II trial to evaluate safety and efficacy of combined trastuzumab and AUY922in advanced non-small cell lung cancer (NSCLC) with HER2 - overexpression or -amplification or - mutation. - TRY
niversity of Cologne0 sites29 target enrollmentMay 10, 2012
ConditionsAdvanced non-smallcell lung cancer with HER2 - overexpression or - amplification or - mutationMedDRA version: 17.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsHerceptin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced non-smallcell lung cancer with HER2 - overexpression or - amplification or - mutation
- Sponsor
- niversity of Cologne
- Enrollment
- 29
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Stage IV NSCLC patients after failure of at least one standard therapy with HER2 protein overexpression (HER2 score 3\+) 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 the following laboratory requirements conducted at least
- •14 days prior to treatment:
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 sodium warfarin (coumadin). Low doses
- •of coumadin (e.g. \< 2mg/day) are permitted
- •Patients with concurrent severe and/or uncontrolled medical conditions (e.g.
- •uncontrolled diabetes mellitus, active untreated or uncontrolled infection,
- •chronic obstructive or chronic restrictive pulmonary disease including
- •dyspnea at rest from any cause or requiring supplementary oxygen therapy)
Outcomes
Primary Outcomes
Not specified
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