A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | April 2016 |
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 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.
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.
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
We found this trial at
11
sites
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