A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01641939
First received: July 13, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: trastuzumab emtansine
Drug: taxane
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic Her2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response (DOR) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Response distribution of treatment-related symptoms as measured by patient-reported outcome data [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Time to gastric cancer symptom progression as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ-STO22) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Quality of life as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: serum concentration-time profile of trastuzumab emtansine [ Time Frame: Cycle 1, Days 1, 2, 3, 4, 8, 15; Cycle 2, Day 1; Cycle 4, Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: serum concentration-time profile of total trastuzumab [ Time Frame: Cycle 1, Days 1, 2, 3, 4, 8, 15; Cycle 2, Day 1; Cycle 4, Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: plasma concentration-time profile of DM1 [ Time Frame: Cycle 1, Days 1, 2, 3, 4, 8, 15; Cycle 2, Day 1; Cycle 4, Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 412
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trastuzumab emtansine 3.6 mg Drug: trastuzumab emtansine
trastuzumab emtansine 3.6 mg/kg every 3 weeks
Experimental: trastuzumab emtansine 2.4 mg Drug: trastuzumab emtansine
trastuzumab emtansine 2.4 mg/kg once a week
Active Comparator: Standard taxane therapy Drug: taxane
Standard taxane (docetaxel or paclitaxel) according to investigator choice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01641939

Contacts
Contact: Reference Study ID Number: BO27952 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, California
Recruiting
Bakersfield, California, United States, 93309
Active, not recruiting
Stanford, California, United States, 94305-5151
United States, Connecticut
Active, not recruiting
New Haven, Connecticut, United States, 06520
United States, Kansas
Recruiting
Westwood, Kansas, United States, 66205
United States, Kentucky
Recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States, 02114
Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Recruiting
New York, New York, United States, 10065
United States, Tennessee
Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Recruiting
Houston, Texas, United States, 77030
Argentina
Recruiting
Buenos Aires, Argentina, C1264AAA
Recruiting
Caba, Argentina, C1050AAK
Recruiting
Rosario, Argentina, S2000KZE
Belgium
Active, not recruiting
Leuven, Belgium, 3000
Brazil
Recruiting
Rio de Janeiro, RJ, Brazil, 20560-120
Recruiting
Porto Alegre, RS, Brazil, 90430-090
Recruiting
Porto Alegre, RS, Brazil, 90610-000
Recruiting
Sao Paulo, SP, Brazil, 01246-000
Recruiting
Sorocaba, SP, Brazil, 18030-245
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Recruiting
Brampton, Ontario, Canada, L6R 3J7
Recruiting
Toronto, Ontario, Canada, M5B 1W8
Recruiting
Toronto, Ontario, Canada, M4C 3E7
China
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Beijing, China, 100142
Not yet recruiting
Beijing, China, 100021
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Beijing, China, 100071
Not yet recruiting
Changchun, China, 130012
Not yet recruiting
Changchun, China, 130021
Not yet recruiting
Changzhou, China, 213003
Not yet recruiting
ChongQing, China, 400042
Not yet recruiting
Fuzhou, China, 350014
Not yet recruiting
Fuzhou, China, 350005
Not yet recruiting
Fuzhou, China, 350025
Not yet recruiting
Guangzhou, China, 510060
Not yet recruiting
Hangzhou, China, 310016
Not yet recruiting
Harbin, China, 150081
Not yet recruiting
Jiangsu, China, 210009
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Nanjing, China, 210002
Not yet recruiting
Shanghai, China, 200080
Not yet recruiting
Shanghai, China, 200032
Not yet recruiting
Shenyang, China, 110016
Not yet recruiting
Shijiazhuang, China, 050011
Not yet recruiting
Xi An city, China, 710061
Not yet recruiting
Xuzhou, China, 221002
Not yet recruiting
Zhengzhou, China, 450052
Not yet recruiting
Zhengzhou, China, 450008
Czech Republic
Recruiting
Hradec Kralove, Czech Republic, 500 05
Recruiting
Olomouc, Czech Republic, 775 20
Recruiting
Praha 2, Czech Republic, 128 08
Recruiting
Praha 5, Czech Republic, 150 06
Finland
Completed
Tampere, Finland, 33520
France
Active, not recruiting
Brest, France, 29200
Terminated
Clichy, France, 92118
Recruiting
Montpellier, France, 34298
Completed
Paris, France, 75571
Recruiting
Paris, France, 75908
Recruiting
Reims, France, 51092
Recruiting
Toulouse, France, 31059
Germany
Active, not recruiting
Berlin, Germany, 13353
Recruiting
Dresden, Germany, 01307
Active, not recruiting
Hamburg, Germany, 20249
Recruiting
Köln, Germany, 50937
Terminated
Landshut, Germany, 84028
Active, not recruiting
Magedburg, Germany, 39104
Guatemala
Recruiting
Guatemala, Guatemala, 01009
Recruiting
Guatemala City, Guatemala, 01015
Hungary
Recruiting
Budapest, Hungary, 1097
Recruiting
Szeged, Hungary, 6701
Recruiting
Szolnok, Hungary, 5004
Recruiting
Zalaegerszeg, Hungary, 8900
Italy
Recruiting
Catanzaro, Calabria, Italy, 88100
Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Recruiting
Torino, Piemonte, Italy, 10126
Recruiting
Firenze, Toscana, Italy, 50139
Recruiting
Pisa, Toscana, Italy, 56100
Japan
Active, not recruiting
Aichi, Japan, 464-8681
Active, not recruiting
Chiba, Japan, 277-8577
Active, not recruiting
Chiba, Japan, 260-8717
Recruiting
Ehime, Japan, 791-0280
Recruiting
Hokkaido, Japan, 060-8648
Recruiting
Hyogo, Japan, 663-8501
Recruiting
Hyogo, Japan, 673-8558
Recruiting
Ibaraki, Japan, 309-1793
Recruiting
Miyagi, Japan, 980-8574
Active, not recruiting
Osaka, Japan, 589-8511
Recruiting
Osaka, Japan, 565-0871
Active, not recruiting
Saitama, Japan, 362-0806
Active, not recruiting
Shizuoka, Japan, 420-8527
Active, not recruiting
Shizuoka, Japan, 411-8777
Recruiting
Tochigi, Japan, 320-0834
Active, not recruiting
Tokyo, Japan, 104-0045
Active, not recruiting
Tokyo, Japan, 105-8470
Active, not recruiting
Tokyo, Japan, 113-8677
Recruiting
Tokyo, Japan, 135-8550
Korea, Republic of
Active, not recruiting
Seoul, Korea, Republic of, 110744
Recruiting
Seoul, Korea, Republic of, 138-736
Active, not recruiting
Seoul, Korea, Republic of, 120-752
Recruiting
Seoul, Korea, Republic of, 135-710
Active, not recruiting
Seoul, Korea, Republic of, 137-807
Completed
Seoul, Korea, Republic of, 136-705
Malaysia
Recruiting
Kuala Lumpur, Malaysia, 59100
Recruiting
Sabah, Malaysia, 88996
Mexico
Recruiting
Aguascalientes, Mexico, 20230
Active, not recruiting
Chihuahua, Mexico, 31000
Recruiting
Mexico DF, Mexico, 06726
Panama
Recruiting
Panama City, Panama, 32400
Peru
Recruiting
Chiclayo, Peru, CIX
Recruiting
Cusco, Peru, 08006
Recruiting
Jesus Maria, Peru, Lima 11
Recruiting
Lima, Peru, 34
Philippines
Terminated
Cebu, Philippines, 6000
Active, not recruiting
Quezon City, Luzon, Philippines, 1101
Poland
Terminated
Gdansk, Poland, 80-952
Terminated
Krakow, Poland, 30-501
Recruiting
Poznan, Poland, 61-866
Recruiting
Rybnik, Poland, 44-200
Recruiting
Warszawa, Poland, 02-781
Romania
Recruiting
Bucharest, Romania, 022328
Recruiting
Cluj-Napoca, Romania, 400058
Completed
Cluj-Napoca, Romania, 400015
Active, not recruiting
Targu Mures, Romania, 540141
Russian Federation
Recruiting
Arkhangelsk, Russian Federation, 163045
Recruiting
Ivanovo, Russian Federation, 153040
Active, not recruiting
Omsk, Russian Federation, 644013
Recruiting
Pyatigorsk, Russian Federation, 357502
Completed
Tula, Russian Federation, 300053
Singapore
Recruiting
Singapore, Singapore, 169610
Spain
Active, not recruiting
Oviedo, Asturias, Spain, 33006
Recruiting
Santander, Cantabria, Spain, 39008
Recruiting
Santiago de Compostela, La Coruña, Spain, 15706
Recruiting
Barcelona, Spain, 08036
Recruiting
Madrid, Spain, 28046
Recruiting
Madrid, Spain, 28041
Recruiting
Sevilla, Spain, 41013
Recruiting
Zaragoza, Spain, 50009
Taiwan
Recruiting
Kaohsung, Taiwan, 883
Recruiting
Taipei, Taiwan, 100
Recruiting
Taoyuan, Taiwan, 333
Turkey
Recruiting
Erzurum, Turkey, 25240
Recruiting
Istanbul, Turkey, 34300
Active, not recruiting
Istanbul, Turkey, 34890
Recruiting
Izmir, Turkey, 35100
Recruiting
S?hhiye, ANKARA, Turkey, 06100
United Kingdom
Recruiting
Cardiff, United Kingdom, CF14 2TL
Recruiting
Glasgow, United Kingdom, G12 0YN
Recruiting
London, United Kingdom, SW3 6JJ
Recruiting
Manchester, United Kingdom, M2O 4BX
Active, not recruiting
Sutton, United Kingdom, SM2 5PT
Recruiting
Weston Super Mare, United Kingdom, BS23 4TQ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01641939     History of Changes
Other Study ID Numbers: BO27952, 2012-000660-22
Study First Received: July 13, 2012
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Taxane
Trastuzumab
Maytansine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014