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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 13, 2014
Last verified: October 2014

July 13, 2012
October 13, 2014
September 2012
December 2016   (final data collection date for primary outcome measure)
Overall survival (OS) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Phase III part: Overall survival (OS) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Phase II part : Determination of trastuzumab emtansine dose for Phase III part of the study [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01641939 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 [ 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 ]
Not Provided
Not Provided
 
A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer
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

This multicenter, randomized, adaptive Phase II/III study will evaluate the effi cacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane tre atment in patients with HER2-positive advanced gastric cancer. At the start of t he trial, patients will be randomized to one of three treatment arms: Arm A: tra stuzumab 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 inves tigator choice). At the end of the first stage of the study, the dose and schedu le of trastuzumab emtansine that will be used in the second stage of the study w ill 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 cycle s (12 weeks). Once a trastuzumab emtansine regimen has been selected, Stage I p atients who were assigned to the treatment arm which was selected for Stage II o f 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 receiv e their assigned regimen and will continue to be followed for efficacy and safet y. In Stage II of the study, additional patients will be recruited and randomize d to either the selected regimen of trastuzumab emtansine or to the standard tax ane therapy. Patients will receive study treatment until disease progression, un acceptable toxicity or withdrawal.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Drug: taxane
    Standard taxane (docetaxel or paclitaxel) according to investigator choice
  • Drug: trastuzumab emtansine
    trastuzumab emtansine 3.6 mg/kg every 3 weeks
  • Drug: trastuzumab emtansine
    trastuzumab emtansine 2.4 mg/kg once a week
  • Active Comparator: Standard taxane therapy
    Intervention: Drug: taxane
  • Experimental: trastuzumab emtansine 2.4 mg
    Intervention: Drug: trastuzumab emtansine
  • Experimental: trastuzumab emtansine 3.6 mg
    Intervention: Drug: trastuzumab emtansine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
412
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: BO27952 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Argentina,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Finland,   France,   Germany,   Guatemala,   Hungary,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Panama,   Peru,   Philippines,   Poland,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   Turkey,   United Kingdom
 
NCT01641939
BO27952, 2012-000660-22
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP