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

Advanced Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01402401
• Other study ID #: CAUY922A2205
• Secondary ID: 2011-002570-23
• Status: Terminated
• Phase: Phase 2
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• AUY922

• Trastuzumab

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Leuven
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Nice Cedex 2
France	Novartis Investigative Site	Reims
Germany	Novartis Investigative Site	Heilbronn
Germany	Novartis Investigative Site	Mannheim	Baden-Württemberg
Italy	Novartis Investigative Site	Modena	MO
Japan	Novartis Investigative Site	Kashiwa	Chiba
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Spain	Novartis Investigative Site	Barcelona	Cataluña
United States	University of Texas/MD Anderson Cancer Center UT SC	Houston	Texas
United States	Clinical Research Alliance	Lake Success	New York
United States	University of California at Los Angeles UCLA LeConte Location	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of AUY922 in combination with trastuzumab as assessed by RECIST		every 6 weeks

External Links

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