Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer
This study has been terminated.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01084330
First received: March 5, 2010
Last updated: April 5, 2013
Last verified: April 2013
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Purpose
A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Gastric Cancer Gastro-esophageal Junction Cancer |
Drug: AUY922 Drug: Docetaxel Drug: Irinotecan |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-label, Multi-center Phase II Study to Compare AUY922 With Docetaxel or Irinotecan in Adult Patients With Advanced Gastric Cancer, Who Have Progressed After One Line of Chemotherapy |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 21 day cycle: treatment until death, lost to follow up or withdrawal ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Estimate of the Overall Survival Treatment Effect to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications. [ Time Frame: 21 day cycle: treatment until death, lost to follow up or withdrawal ] [ Designated as safety issue: No ]
- Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications. [ Time Frame: 21 day cycle: treatment until death, lost to follow up or withdrawal ] [ Designated as safety issue: No ]
- Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922 [ Time Frame: 21 day cycle: treatment until death, lost to follow up or withdrawal ] [ Designated as safety issue: No ]
| Enrollment: | 98 |
| Study Start Date: | April 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AUY922 |
Drug: AUY922
70mg/m2
|
| Active Comparator: Docetaxel or Irinotecan |
Drug: Docetaxel
Docetaxel 75mg/m2
Drug: Irinotecan
Docetaxel or Iriniotecan
Other Name: Iriniotecan 350mg/m2
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Radiologically confirmed advanced gastric cancer
- One previous line of chemotherapy
- Progressive disease
- One measurable lesion
- Blood tests within protocol ranges
- (WHO) Performance Status ≤ 1
- Able to sign informed consent
Exclusion Criteria:
- No symptomatic brain metastases
- No coumarin type anticoagulants
- No liver or kidney disease
- No impaired heart function
- No pregnant or lactating women
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084330
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Hide Study LocationsLocations
| United States, California | |
| USC/Kenneth Norris Comprehensive Cancer Center USC/Norris | |
| Los Angeles, California, United States, 90033 | |
| University of California at Los Angeles Dept. of UCLA (4) | |
| Los Angeles, California, United States, 90095 | |
| UCLA/ University of California Los Angeles Dept. of UCLA (4) | |
| Los Angeles, California, United States, 90095 | |
| United States, Indiana | |
| Horizon Oncology Center | |
| Lafayette, Indiana, United States, 47905 | |
| United States, Maryland | |
| The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU | |
| Baltimore, Maryland, United States, 21231 | |
| United States, New York | |
| Arena Oncology Associates, PC Dept.ofArenaOncologyAssoc(2) | |
| Lake Success, New York, United States, 11042 | |
| United States, Texas | |
| Baylor College of Medicine Baylor Texas Oncology | |
| Dallas, Texas, United States, 75246 | |
| Tyler Cancer Center Dept.ofTylerCancerCtr. (2) | |
| Tyler, Texas, United States, 75702 | |
| Australia, South Australia | |
| Novartis Investigative Site | |
| Adelaide, South Australia, Australia, 5000 | |
| Canada, Quebec | |
| Novartis Investigative Site | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| France | |
| Novartis Investigative Site | |
| Bordeaux Cedex, France, 33075 | |
| Novartis Investigative Site | |
| Lyon Cedex, France, 69373 | |
| Novartis Investigative Site | |
| Toulouse Cedex 3, France, 31052 | |
| Germany | |
| Novartis Investigative Site | |
| Erlangen, Germany, 91054 | |
| Novartis Investigative Site | |
| Ulm, Germany, 89081 | |
| Italy | |
| Novartis Investigative Site | |
| Genova, GE, Italy, 16132 | |
| Novartis Investigative Site | |
| Modena, MO, Italy, 41100 | |
| Novartis Investigative Site | |
| Pisa, PI, Italy, 56100 | |
| Novartis Investigative Site | |
| Roma, RM, Italy, 00168 | |
| Novartis Investigative Site | |
| Napoli, Italy, 80131 | |
| Korea, Republic of | |
| Novartis Investigative Site | |
| Suwon, Gyeonggi-do, Korea, Republic of, 442-723 | |
| Novartis Investigative Site | |
| Seoul, Korea, Republic of, 738-736 | |
| Novartis Investigative Site | |
| Suwon, Korea, Republic of, 442-721 | |
| Netherlands | |
| Novartis Investigative Site | |
| Utrecht, Netherlands, 3584CX | |
| Russian Federation | |
| Novartis Investigative Site | |
| Moscow, Russian Federation, 129128 | |
| Novartis Investigative Site | |
| Moscow, Russian Federation, 115478 | |
| Singapore | |
| Novartis Investigative Site | |
| Singapore, Singapore, 169610 | |
| Switzerland | |
| Novartis Investigative Site | |
| Bellinzona, Switzerland, 6500 | |
| Taiwan | |
| Novartis Investigative Site | |
| Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, Taiwan, 33305 | |
| Novartis Investigative Site | |
| Tainan, Taiwan | |
| Novartis Investigative Site | |
| Taipei, Taiwan | |
| Novartis Investigative Site | |
| Taipei, Taiwan, 10048 | |
| Turkey | |
| Novartis Investigative Site | |
| Ankara, Turkey, 06500 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Surrey, England, United Kingdom, GU2 7XX | |
| Novartis Investigative Site | |
| Sutton, Surrey, United Kingdom, SM2 5PT | |
| Novartis Investigative Site | |
| Glasgow, United Kingdom, G12 0YN | |
| Novartis Investigative Site | |
| Leicester, United Kingdom, LE7 5WW | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01084330 History of Changes |
| Other Study ID Numbers: | CAUY922A2202, 2009-015407-47 |
| Study First Received: | March 5, 2010 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Food and Drug Administration Singapore: Health Sciences Authority Germany: Federal Institute for Drugs and Medicinal Products Canada: Health Canada France: Health Authority |
Keywords provided by Novartis:
|
gastric cancer metastatic gastric cancer advanced gastric cancer |
Additional relevant MeSH terms:
|
Esophageal Diseases Stomach Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Stomach Diseases Irinotecan Docetaxel |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013