Phase II of AUY922 in Second-line Gastric Cancer in Combination With Trastuzumab in HER2 Positive Patients

NCT01402401 | Terminated Phase 2

• 2 other identifiers: CAUY922A22052011-002570-23
• Study Type: interventional
• Target: 21
• Locations: 8 countries
• Sites: 15

Brief Summary

This study will assess the safety and efficacy of AUY922, when administered, in combination with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received trastuzumab plus chemotherapy in the first line.

Conditions

Advanced Gastric Cancer

Keywords

HER2+,; Gastric Cancer,; HSP90,; 2nd-line,; Trastuzumab

Outcome Measures

Primary Outcomes (1)

• efficacy of AUY922 in combination with trastuzumab as assessed by RECIST

  every 6 weeks

Study Arms (1)

AUY922 + Trastuzumab

EXPERIMENTAL

Drug: AUY922; Drug: Trastuzumab

Interventions

AUY922 DRUG

AUY922 + Trastuzumab

Trastuzumab DRUG

AUY922 + Trastuzumab

Eligibility Criteria

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

You may qualify if:

• Written informed consent obtained prior to any screening procedures
• Patients with documented cytological or histological confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and proven HER2 positive.
• Patients with progressive disease (radiological confirmation required according to RECIST) after first line of trastuzumab in combination with chemotherapy for advanced gastric cancer.
• Age ≥ 18 years or age of consent in country of residence and able to sign Informed Consent
• ECOG performance status of 0-1 at study entry
• HER2-overexpressing positive gastric tumor by IHC3+ or IHC2+ with positive in situ hybridization
• Measurable disease according to RECIST (Irradiated lesions can not be considered measurable unless they have clearly progressed since radiotherapy).
• Negative serum pregnancy test. The serum pregnancy test must be obtained prior to any drug administration (≤ 72 hours prior to dosing) in all pre-menopausal women and for women \< 2 years after the onset of menopause.
• Patients must have the following laboratory values:
• Hematologic
• Absolute Neutrophil Count (ANC) ≥1.5x109/L,
• Hemoglobin (Hgb) ≥ 9 g/dL,
• Platelets (plt) ≥100x109/L
• Biochemistry:
• Serum total bilirubin ≤ 1.5 x ULN

You may not qualify if:

• Patients eligible for this study must not meet any of the following criteria:
• Evidence of spinal cord compression or current evidence of CNS metastases. CT/MRI of the brain is mandatory (within 3 weeks before study start) in case of clinical suspicion or evidence of brain metastases
• Patient who are \< 4 weeks since last chemotherapy or treatment with another systemic anti-cancer agent. Patients must have recovered (CTC ≤ 1) from acute toxicities of any previous therapy (with the exception of alopecia).
• Patients may have received prior radiotherapy for management of local disease providing that disease progression has been documented, all toxicities have resolved (CTC ≤ 1) (with the exception of alopecia), and the last fraction of radiotherapy was completed at least 4 weeks prior to the study.
• Prior treatment with an agent that acts via HER2/c-erbB2 targeting other than 1st line trastuzumab, include (but are not limited to) lapatinib and pertuzumab.
• Treatment with therapeutic doses of coumarin-type anticoagulants. (Maximum daily dose of 2 mg, for line patency permitted)
• Patients with malignant ascites that require invasive treatment
• Patients with acute or chronic renal disease; and active and chronic liver disease requiring intervention. Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol.
• Major surgery ≤ 2 weeks prior to enrollment or who have not recovered from such therapy
• Impaired cardiac function
• Concurrent malignancies or invasive cancers diagnosed within the past 5 years, except for adequately treated basal cell cancer of the skin or in situ cancer of the cervix
• Patients receiving chronic or high dose corticosteroids therapy (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed)
• Patients unwilling or unable to comply with the protocol
• Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggesting HIV infection.
• Known hypersensitivity to any of the study drugs or their excipients

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (15)

University of California at Los Angeles UCLA LeConte Location

Los Angeles, California, 90095, United States

Location

Clinical Research Alliance

Lake Success, New York, 11042, United States

Location

University of Texas/MD Anderson Cancer Center UT SC

Houston, Texas, 77030-4009, United States

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Bordeaux, 33075, France

Location

Novartis Investigative Site

Nice, 06189, France

Location

Novartis Investigative Site

Reims, 51092, France

Location

Novartis Investigative Site

Mannheim, Baden-Wurttemberg, 68305, Germany

Location

Novartis Investigative Site

Heilbronn, 74078, Germany

Location

Novartis Investigative Site

Modena, MO, 41100, Italy

Location

Novartis Investigative Site

Kashiwa, Chiba, 277-8577, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Novartis Investigative Site

Seoul, Korea, 110 744, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 135-710, South Korea

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Related Links

• Results for CAUY922A2205 can be found on the Novartis Clinical Trial Results website

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

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

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 24, 2011
• First Posted: July 26, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 10, 2020

Record last verified: 2020-08

Locations

FR (3); ES (1); JP (2); US (3); DE (2); IT (1); BE (1); KR (2)