NCT01389583

Brief Summary

A Phase II Study of AUY922, Novel HSP Inhibitor, in Patients with Advanced GIST Failed to or Intolerance of Imatinib and Sunitinib Therapy Primary endpoint:

  • The primary endpoint of this study is to assess disease control rate (complete response + partial response + stable disease≧4 months) of AUY922 in patients with advanced GIST failed to imatinib and sunitinib Secondary endpoints:
  • To determinate the objective response rate (ORR, complete response + partial response)
  • To determinate the time to tumor progression (TTP)
  • To evaluate the safety and toxicity profiles of AUY922
  • To evaluate the pharmacokinetics profile of AUY922 in Taiwan GIST population
  • To access the pharmacodynamic effect of AUY922 on HSP client proteins in blood and tumor if feasible , i.e. HSP70, in Taiwan GIST population
  • To access the tissue biomarkers pre-treatment and 4wks post treatment if feasible, i.e. HSP70, c-KIT, PDGFRA mutation, ...etc in Taiwan GIST population Exploratory endpoints:
  • PET imaging; sSUVmax

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

February 25, 2015

Status Verified

September 1, 2013

Enrollment Period

3.6 years

First QC Date

July 6, 2011

Last Update Submit

February 23, 2015

Conditions

Gastrointestinal Stromal Tumor

Keywords

GIST(Gastrointestinal stromal tumor)HSP(Heat Shock Protein)Biomarker

Outcome Measures

Primary Outcomes (1)

  • disaese control rate

    The primary endpoint of this study is to assess disease control rate (complete response + partial response + stable disease≧4 months) of AUY922 in patients with advanced GIST failed to imatinib and sunitinib

    4 months

Secondary Outcomes (1)

  • response rate

    3 years

Study Arms (1)

AUY922

EXPERIMENTAL

AUY922

Drug: AUY922

Interventions

AUY922DRUG

70 mg/m2 60-min i.v. infusion weekly

AUY922

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically proven CD117-positive and/or c-kit or PDGFR mutation gastrointestinal stromal tumor (GIST), which is metastatic or unresectable, locally advanced, and have failed to or intolerance of prior imatinib and sunitinib treatment
  • At least one measurable lesion according to the RECIST criteria (version 1.1)
  • Aged between 20-75 years
  • With Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
  • Life expectancy ≥ 4 months
  • At least 4 weeks apart from prior systemic (including chemotherapy, approved targeted therapy or investigational agent) and surgical treatment, and recovery from all prior treatment-related toxicity to grade \< 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
  • With adequate organ and marrow function as defined below:
  • WBC ≥ 3.00 × 103/ mm3 and absolute neutrophil count ≥ 1.50 × 103/ mm3
  • Platelet count ≥ 100.0 × 103/mm3
  • Hemoglobin level ≥ 9 gm/dL
  • Serum creatinine (Cr) ≦1.5 x UNL or eGFR ≥ 60 ml/min (by Cockroft-Gault method)
  • Serum bilirubin ≤ 1.5 x UNL , ALT ≤ 2.5x UNL. If obstructive jaundice with proper drainage, serum bilirubin ≤ 3 x UNL is acceptable.
  • Women of childbearing potential and men must agree to use accepted methods of contraception during the course of the study and at least 3 months after last dose of treatment
  • Willing to have tumor biopsy at screening (all patients) and able to comply with study requirement at 4 weeks post treatment
  • With ability to understand and the willingness to sign Informed Consent Form.

You may not qualify if:

  • Have received imatinib or sunitinib, chemotherapy, any investigational agents or participate in any investigational drug study within 28 days before enrolment
  • Have major surgery within 28 days before enrolment (diagnostic biopsy or line placement is not considered major surgery)
  • With active multiple cancers or history of other malignancy within the last three years, except treated curable non-melanoma skin cancer, in-situ cervical cancer, Dukes' A colorectal cancer.
  • With known CNS metastasis
  • Symptoms of heart failure or greater to Class III (by NYHA criteria) or history of uncontrolled dysrrhythmias
  • Sinus bradycardia (resting heart rate \<50 beats/min) secondary to intrinsic conduction system disease; Patients with sinus bradycardia secondary to pharmacologic treatment may enrol if they are allowed to withdraw the treatment and can result in normalization of the resting heart rate to within normal limits
  • Myocardial infarction or active ischemic heart within 6 months
  • Screening QTc \>450 msec in males; QTc \>470 msec in females, or previous history of QTc prolongation while taking other medications
  • Presence of active infection or systemic use of antimicrobials within 72 hours prior to enrolment
  • Treatment with therapeutic doses of coumadin-type anticoagulants. \[Maximum daily dose of 2mg, for line patency permitted\]
  • Patients who are unable to comply protocol requirement, i.e. tumor tissue sampling or blood sampling for pharmacodynamic and pharmacokinetics study
  • Patients who have know hypersensitivity or prior therapy of any HSP90 inhibitor compound or its derivatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Health Research of Institutes, Taiwan Cooperative Oncology Group

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

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

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Li-Tzong Chen, M.D.,Ph.D

    National Health Research of Institutes, Taiwan Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brong-rong Chen, BS

CONTACT

886-2-2653-4401brong@nhri.org.tw

Study Design

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

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 8, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2015

Study Completion

October 1, 2019

Last Updated

February 25, 2015

Record last verified: 2013-09

Locations

TW(1)