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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01402401
First received: July 24, 2011
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Advanced Gastric Cancer
Drug: AUY922 + Trastuzumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AUY922 in Combination With Trastuzumab Standard Therapy as Second-line Treatment in Patients With HER2-positive Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • efficacy of AUY922 in combination with trastuzumab as assessed by RECIST [ Time Frame: every 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 21
Study Start Date: November 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AUY922 + Trastuzumab Drug: AUY922 + Trastuzumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients eligible for inclusion in this study have to meet all of the following criteria:

  1. Written informed consent obtained prior to any screening procedures
  2. Patients with documented cytological or histological confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and proven HER2 positive.
  3. Patients with progressive disease (radiological confirmation required according to RECIST) after first line of trastuzumab in combination with chemotherapy for advanced gastric cancer.
  4. Age ≥ 18 years or age of consent in country of residence and able to sign Informed Consent
  5. ECOG performance status of 0-1 at study entry
  6. HER2-overexpressing positive gastric tumor by IHC3+ or IHC2+ with positive in situ hybridization
  7. Measurable disease according to RECIST (Irradiated lesions can not be considered measurable unless they have clearly progressed since radiotherapy).
  8. 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.
  9. 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
  • Serum albumin > 2.5 g/dl
  • Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 ml/min.
  • AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastases are present

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria:

  1. 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
  2. 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).
  3. 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.
  4. 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.
  5. Treatment with therapeutic doses of coumarin-type anticoagulants. (Maximum daily dose of 2 mg, for line patency permitted)
  6. Patients with malignant ascites that require invasive treatment
  7. 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.
  8. Major surgery ≤ 2 weeks prior to enrollment or who have not recovered from such therapy
  9. Impaired cardiac function
  10. 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
  11. 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)
  12. Patients unwilling or unable to comply with the protocol
  13. Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggesting HIV infection.
  14. Known hypersensitivity to any of the study drugs or their excipients
  15. Participation in another clinical study within 30 days before first study treatment
  16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
  17. Fertile women of childbearing potential (WOCBP) not using adequate contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402401

Locations
United States, California
University of California at Los Angeles UCLA LeConte Location
Los Angeles, California, United States, 90095
United States, New York
Clinical Research Alliance
Lake Success, New York, United States, 11042
United States, Texas
University of Texas/MD Anderson Cancer Center UT SC
Houston, Texas, United States, 77030-4009
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
France
Novartis Investigative Site
Bordeaux Cedex, France, 33075
Novartis Investigative Site
Nice Cedex 2, France, 06189
Novartis Investigative Site
Reims, France, 51092
Germany
Novartis Investigative Site
Mannheim, Baden-Württemberg, Germany, 68305
Novartis Investigative Site
Heilbronn, Germany, 74078
Italy
Novartis Investigative Site
Modena, MO, Italy, 41100
Japan
Novartis Investigative Site
Kashiwa, Chiba, Japan, 277-8577
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 060-8648
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 110 744
Spain
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08035
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: NCT01402401     History of Changes
Other Study ID Numbers: CAUY922A2205, 2011-002570-23
Study First Received: July 24, 2011
Last Updated: February 20, 2014
Health Authority: United States: Food and Drug Administration
Netherlands: Dutch Health Care Inspectorate (IGZ)
Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Italy: Ministry of Labor, Health & Social Affairs, Department Innovation (Ministero della Salute)
France: French Agency for the Safety of Health Products (AFSSAPS)
Japan: Pharmaceuticals and Medical Devices Agency
Spain: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Belgium: Belgian Federal Public Service

Keywords provided by Novartis:
HER2+,
Gastric Cancer,
HSP90,
2nd-line,
Trastuzumab

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014