A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: taxane Type: Drug
Name: trastuzumab emtansine Type: Drug
Name: trastuzumab emtansine Type: Drug
Overall Status
Recruiting
Summary
This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane treatment in patients with HER2-positive advanced gastric cancer. At the start of the trial, patients will be randomized to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 mg/kg every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg every week; Arm C: standard taxane therapy (docetaxel or paclitaxel per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected. The regimen selection analysis will be made after approximately 100 patients across all three study arms have been treated for at least 4 cycles (12 weeks).

Once a trastuzumab emtansine regimen has been selected, Stage I patients who were assigned to the treatment arm which was selected for Stage II of the study and patients who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I patients who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional patients will be recruited and randomized to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Patients will receive study treatment until disease progression, unacceptable toxicity or withdrawal.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Adult patients, aged >/= 18 years

- ECOG performance status of 0 or 1.

- Life expectancy of at least 12 weeks from the first dose of study treatment

- Measurable and/or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

- Adequate organ function as determined by the following laboratory results, within 28 days prior to randomization

- Patients must have a history of advanced gastric cancer (AGC), defined as unresectable and locally advanced or metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction (GEJ), and must have experienced disease progression during or after first-line therapy for their disease.

- HER2-positive tumor (primary tumor or metastatic lesion) as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization)

- Patients must have received at least one prior chemotherapy regimen for AGC; prior therapy does not need to have included HER2-directed therapy.

- First-line therapy for AGC, including adenocarcinoma of the GEJ, must have included a combination of at least a platinum- and a fluoropyrimidine-based treatment given concurrently; prior therapy does not need to have included a HER2-directed therapy.

- Adjuvant or neoadjuvant therapy for AGC is allowed.

Exclusion Criteria:

- An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed therapy until the time of randomization

- Prior treatment with trastuzumab emtansine, docetaxel, or paclitaxel either as single agents or as part of a treatment regimen.

- Treatment with any investigational anticancer drug within 21 days of the first study treatment administration

- More than one prior line of therapy for advanced gastric cancer

- History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome

- Brain metastases that are untreated or symptomatic or require any radiation, surgery, or steroid therapy to control symptoms from brain metastases within 1 month of randomization

- Peripheral neuropathy Grade >/=2

- Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, serious cardiac arrhythmia)

- Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers)

- Clinically significant bleeding within 30 days before enrollment

- For female patients, current pregnancy or lactation

- Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment

- Infection with HIV or hepatitis B virus, hepatitis C virus
Locations
Bakersfield, California, United States
Status: Active, not recruiting
Stanford, California, United States
Status: Active, not recruiting
New Haven, Connecticut, United States
Status: Active, not recruiting
Westwood, Kansas, United States
Status: Completed
Louisville, Kentucky, United States
Status: Terminated
Boston, Massachusetts, United States
Status: Active, not recruiting
Boston, Massachusetts, United States
Status: Completed
New York, New York, United States
Status: Active, not recruiting
Nashville, Tennessee, United States
Status: Completed
Houston, Texas, United States
Status: Active, not recruiting
Buenos Aires, Argentina
Status: Completed
Caba, Argentina
Status: Completed
Rosario, Argentina
Status: Completed
Leuven, Belgium
Status: Completed
Rio de Janeiro, RJ, Brazil
Status: Completed
Porto Alegre, RS, Brazil
Status: Completed
Porto Alegre, RS, Brazil
Status: Completed
Barretos, SP, Brazil
Status: Completed
Jau, SP, Brazil
Status: Completed
Sao Paulo, SP, Brazil
Status: Completed
Sorocaba, SP, Brazil
Status: Completed
Vancouver, British Columbia, Canada
Status: Completed
Brampton, Ontario, Canada
Status: Completed
Toronto, Ontario, Canada
Status: Completed
Toronto, Ontario, Canada
Status: Completed
Beijing, China
Status: Recruiting
Beijing, China
Status: Recruiting
Beijing, China
Status: Not yet recruiting
Changchun, China
Status: Recruiting
Changchun, China
Status: Recruiting
Changzhou, China
Status: Recruiting
ChongQing, China
Status: Recruiting
Fuzhou, China
Status: Recruiting
Guangzhou, China
Status: Recruiting
Hangzhou, China
Status: Recruiting
Harbin, China
Status: Recruiting
Nanjing, China
Status: Recruiting
Nanjing, China
Status: Recruiting
Nantong, China
Status: Recruiting
Shanghai, China
Status: Recruiting
Shanghai, China
Status: Recruiting
Shenyang, China
Status: Recruiting
Wuhan, China
Status: Recruiting
Xi'an, China
Status: Recruiting
Xuzhou, China
Status: Recruiting
Zhengzhou, China
Status: Not yet recruiting
Zhengzhou, China
Status: Not yet recruiting
Hradec Kralove, Czech Republic
Status: Active, not recruiting
Olomouc, Czech Republic
Status: Active, not recruiting
Praha 2, Czech Republic
Status: Active, not recruiting
Praha 5, Czech Republic
Status: Completed
Tampere, Finland
Status: Active, not recruiting
Brest, France
Status: Active, not recruiting
Clichy, France
Status: Terminated
Montpellier, France
Status: Active, not recruiting
Paris, France
Status: Completed
Paris, France
Status: Completed
Reims, France
Status: Completed
Toulouse, France
Status: Completed
Berlin, Germany
Status: Active, not recruiting
Dresden, Germany
Status: Active, not recruiting
Hamburg, Germany
Status: Active, not recruiting
Köln, Germany
Status: Active, not recruiting
Landshut, Germany
Status: Terminated
Magedburg, Germany
Status: Active, not recruiting
Guatemala City, Guatemala
Status: Active, not recruiting
Guatemala, Guatemala
Status: Terminated
Budapest, Hungary
Status: Active, not recruiting
Szeged, Hungary
Status: Completed
Szolnok, Hungary
Status: Completed
Zalaegerszeg, Hungary
Status: Completed
Catanzaro, Calabria, Italy
Status: Active, not recruiting
Bologna, Emilia-Romagna, Italy
Status: Active, not recruiting
Torino, Piemonte, Italy
Status: Completed
Firenze, Toscana, Italy
Status: Completed
Pisa, Toscana, Italy
Status: Active, not recruiting
Aichi, Japan
Status: Active, not recruiting
Chiba, Japan
Status: Active, not recruiting
Chiba, Japan
Status: Active, not recruiting
Ehime, Japan
Status: Active, not recruiting
Hokkaido, Japan
Status: Completed
Hyogo, Japan
Status: Completed
Hyogo, Japan
Status: Active, not recruiting
Ibaraki, Japan
Status: Completed
Miyagi, Japan
Status: Completed
Osaka, Japan
Status: Completed
Osaka, Japan
Status: Active, not recruiting
Saitama, Japan
Status: Active, not recruiting
Shizuoka, Japan
Status: Completed
Shizuoka, Japan
Status: Completed
Tochigi, Japan
Status: Active, not recruiting
Tokyo, Japan
Status: Active, not recruiting
Tokyo, Japan
Status: Active, not recruiting
Tokyo, Japan
Status: Active, not recruiting
Tokyo, Japan
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Completed
Seoul, Korea, Republic of
Status: Active, not recruiting
Seoul, Korea, Republic of
Status: Completed
Kuala Lumpur, Malaysia
Status: Completed
Sabah, Malaysia
Status: Completed
Aguascalientes, Mexico
Status: Completed
Chihuahua, Mexico
Status: Completed
Mexico DF, Mexico
Status: Completed
Panama City, Panama
Status: Completed
Chiclayo, Peru
Status: Terminated
Cusco, Peru
Status: Completed
Jesus Maria, Peru
Status: Completed
Lima, Peru
Status: Terminated
Cebu, Philippines
Status: Terminated
Quezon City, Luzon, Philippines
Status: Completed
Gdansk, Poland
Status: Terminated
Krakow, Poland
Status: Terminated
Poznan, Poland
Status: Completed
Rybnik, Poland
Status: Completed
Warszawa, Poland
Status: Completed
Bucharest, Romania
Status: Active, not recruiting
Cluj-Napoca, Romania
Status: Completed
Cluj-Napoca, Romania
Status: Active, not recruiting
Targu Mures, Romania
Status: Completed
Arkhangelsk, Russian Federation
Status: Completed
Ivanovo, Russian Federation
Status: Completed
Omsk, Russian Federation
Status: Completed
Pyatigorsk, Russian Federation
Status: Active, not recruiting
Tula, Russian Federation
Status: Completed
Singapore, Singapore
Status: Completed
Oviedo, Asturias, Spain
Status: Active, not recruiting
Santander, Cantabria, Spain
Status: Active, not recruiting
Santiago de Compostela, La Coruña, Spain
Status: Completed
Barcelona, Spain
Status: Completed
Madrid, Spain
Status: Active, not recruiting
Madrid, Spain
Status: Active, not recruiting
Sevilla, Spain
Status: Completed
Zaragoza, Spain
Status: Completed
Kaohsung, Taiwan
Status: Active, not recruiting
Taipei, Taiwan
Status: Active, not recruiting
Taoyuan, Taiwan
Status: Active, not recruiting
Erzurum, Turkey
Status: Completed
Istanbul, Turkey
Status: Completed
Istanbul, Turkey
Status: Completed
Izmir, Turkey
Status: Active, not recruiting
Sıhhiye, ANKARA, Turkey
Status: Completed
Cardiff, United Kingdom
Status: Active, not recruiting
Glasgow, United Kingdom
Status: Completed
London, United Kingdom
Status: Active, not recruiting
Manchester, United Kingdom
Status: Active, not recruiting
Sutton, United Kingdom
Status: Completed
Weston Super Mare, United Kingdom
Status: Active, not recruiting
Start Date
September 2012
Completion Date
December 2016
Sponsors
Hoffmann-La Roche
Source
Hoffmann-La Roche
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page