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

ovartis Pharma Services AG0 sites48 target enrollmentSeptember 20, 2011

ConditionsPatients with documented advanced HER2 positive gastric cancer progressing after clinical benefit to 1st line treatment with trastuzumab containing treatment. Clinical benefit is defined as overall response or stable disease of at least 12 weeks, from start of the 1st line therapy with trastuzumab as per RECIST.MedDRA version: 14.1Level: LLTClassification code 10066896Term: HER-2 positive gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsHerceptin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients with documented advanced HER2 positive gastric cancer progressing after clinical benefit to 1st line treatment with trastuzumab containing treatment. Clinical benefit is defined as overall response or stable disease of at least 12 weeks, from start of the 1st line therapy with trastuzumab as per RECIST.
Sponsor: ovartis Pharma Services AG
Enrollment: 48
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 20, 2011

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharma Services AG

Eligibility Criteria

Inclusion Criteria

•Patients eligible for inclusion in this study have to meet all of the following criteria:
•\- 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 hematologic and biochemistry laboratory values as defined in the protocol

Exclusion Criteria

•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 must be \= 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