AUY922 in Patient With Stage IV NSCLC

NCT01922583 | Completed Phase 2

• 2 other identifiers: CAUY922ATW02T(201302063MIPD)1020009413
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open-label, single-arm, multicenter phase II trial in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Keywords

NSCLC, EGFR mutation

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  To define the by RECIST 1.1 of AUY922 in patients with stage IV EGFR T790M, EGFR exon 20 and other uncommon, HER2, or BRAF-mutated; ALK, ROS1, or RET-rearranged NSCLC

  Patients will be followed up for 2 years(post disease progression)

Secondary Outcomes (2)

• Efficacy, progression-free survival (PFS)

  Patients will be followed up for PFS and OS for 2 years.(post disease progression)

• overall survival (OS)

  Patients will be followed up for OS for 2 years.(post disease progression)

Study Arms (1)

Vial

EXPERIMENTAL

AUY922 will be administered via IV over 1 hour once weekly in a 21 day cycle until disease progression

Drug: AUY922

Interventions

AUY922 DRUG

AUY922 will be administered via IV over 1 hour once weekly in a 21 day cycle until disease progression

Vial

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven diagnosis of stage IV NSCLC (AJCC 7th) which had been treated with one systemic therapy.
• One of the molecular alterations as follows:
• EGFR mutations in exon 20 T790M.
• EGFR mutations in exon 20; in-frame duplication and/or insertion (e.g. A767\_V769dupASV or H773\_V774insH) or point mutations other than T790M; or other uncommon mutations.
• HER2 mutation in exon 20; in-frame duplication and/or insertion (e.g. YVMA 776-779 ins).
• BRAF mutation in exon 15; point mutation (e.g. V600E) or in exon 11; point mutation (e.g. G469A, D594G).
• ALK translocation resulting in EML4-ALK, KIF5B-ALK, or TFG-ALK fusion as determined by an ALK break apart FISH assay and defined by an increase in the distance of 5' and 3' ALK probes (split 5'-3') or the loss of the 5' probe (single 3'). Positive ALK results from other methods such as immunohistochemistry (IHC) or reverse transcriptase polymerase chain reaction testing may also be acceptable.
• ROS1 translocation resulting in CD74-ROS1 or SLC34A2-ROS1, etc.
• RET translocation resulting in KIF5B-RET fusion, etc.
• Patients with brain metastases are eligible if treated and neurologically stable for at least 2 weeks and is not taking any steroid.
• Any prior chemotherapy, targeted therapy (monoclonal antibodies), or major surgeries must have had completed at least 4 weeks before initiation of study medication. Any prior targeted therapy (tyrosine kinase inhibitors), radiotherapy or minor surgeries must have had completed at least 2 weeks before initiation of study medication. Any acute toxicity must have recovered to \<=grade 1 (except for alopecia).
• Patients must have measurable or evaluable disease as per RECIST version 1.1.
• years of age or older
• ECOG performance status 0-2
• Adequate organ function as defined by the following criteria:

You may not qualify if:

• Currently on other therapeutic clinical trials
• Prior treatment of HSP90 inhibitors
• Any of the following within 3 months before initiation of study medication
• Myocardial infarction
• Unstable angina
• Coronary artery bypass graft
• Congestive heart failure NYHA functional class III or IV
• Cerebral vascular accident
• Transient ischemic attack
• Uncontrolled hypertension at screening
• Ongoing cardiac arrhythmias of NCI CTCAE grade \>=2
• Active infection requiring antibiotics
• Pregnancy or breast feeding
• Prior malignancy within the past 5 years (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, and early prostate cancer).
• Active hepatitis B or C; positive HIV test result.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (3)

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

Department of Oncology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

5-(2,4-dihydroxy-5-isopropylphenyl)-4-(4-morpholin-4-ylmethylphenyl)isoxazole-3-carboxylic acid ethylamide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chih-Hsin Yang, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 14, 2013
• Study Start: January 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: July 18, 2018

Record last verified: 2017-02

Locations

TW (3)