Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malign… (NCT00526045) | Clinical Trial Compass
CompletedPhase 1/2
Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients
United States117 participantsStarted 2007-07
Plain-language summary
This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose. Phase II expansion arms will investigate efficacy in patients with either HER2 positive or ER positive locally advanced or metastatic breast cancer. Additional patients with advanced solid malignancies will also be investigated in a separate expansion arm. Safety, pharmacokinetics and pharmacodynamics will be assessed.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Dose-escalation and MTD dose expansion arm: Patients with histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists.
✓. Females patients with HER2 positive non-operable locally advanced or metastatic breast cancer must have:
✓. Female patients with ER positive non-operable locally advanced or metastatic breast cancer patients who received standard sequence lines of endocrine therapy and whose disease has progressed on at least one and up to 3 lines of endocrine and/or cytotoxic therapy for advanced disease.
✓. All patients must have at least one measurable lesion as defined by RECIST. Irradiated lesions are only evaluable for disease progression.
✓. All patients must have progressive disease before entering the study
✓. Age ≥ 18 years.
✓. World Health Organization (WHO) Performance Status of ≤ 2.
✓. Life expectancy of ≥ 12 weeks.
Exclusion criteria
What they're measuring
1
The safe dose of AUY922 when administered once a week
✕. Prior treatment with any HSP90 or HDAC inhibitor compound.
✕. Patient who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:
✕. Patients who have not recovered from side effects of previous systemic anticancer therapy to less than grade 2 CTCAE prior to the first dose.
✕. Pregnant or lactating women.
✕. Cardia exclusion criteria:
✕. Known diagnosis of HIV infection (HIV testing is not mandatory).
✕. Acute or chronic liver disease, acute or chronic renal disease or other concurrent severe and/or uncontrolled medical conditions (e.g. uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.