Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT01084330

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 or Irinotecan	Phase II

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:

MedlinePlus related topics: Cancer Esophagus Disorders Stomach Cancer

Drug Information available for: Irinotecan U 101440E Docetaxel Irinotecan hydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	120
Study Start Date:	April 2010
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AUY922	Drug: AUY922 70mg/m2
Active Comparator: Docetaxel or Irinotecan	Drug: Docetaxel or Irinotecan Docetaxel 75mg/m2 Irinotecan 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

Show 47 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01084330 History of Changes
Other Study ID Numbers:	CAUY922A2202, Eudra CT 2009-015407-47
Study First Received:	March 5, 2010
Last Updated:	April 21, 2011
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 February 09, 2012