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

Study Status

Open to Enrollment

Study Description

Full protocol 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

This clinical trial is for men and women with advanced gastric (stomach) cancer or cancer of the gastroesophageal junction (GEJ) that is:

  • HER2-positive, and
  • Has been previously treated

The study is evaluating an experimental cancer treatment called trastuzumab emtansine (T-DM1).

The purpose of the study is to determine the effectiveness of trastuzumab emtansine in treating advanced HER2-positive gastric or GEJ cancer, compared to treatment with the physician’s choice of taxane thereapy (paclitaxel or docetaxel).

Trastuzumab emtansine is composed of a chemotherapy agent (DM1) linked to a monoclonal antibody (a type of protein normally made by the immune system to help defend the body from infection and cancer). The monoclonal antibody attaches to the HER2 protein on cancer cells. In earlier clinical trials, some people treated with trastuzumab emtansine experienced tumor shrinkage.

The study has two parts. The first part is being done to determine what dose of trastuzumab emtansine should be used for treating people with advanced HER2-positive gastric cancer.

Participants enrolled in Part 1 will be randomly assigned to one of 3 treatment groups:

  •  Group 1: Trastuzumab emtansine once every 21 days at a dose of 3.6 mg.kg
  •  Group 2: Trastuzumab emtansine weekly at a dose of 2.4 mg/kg
  • Group 3: Either docetaxel via infusion every 21 days or weekly paclitaxel via infusion (selected by physician)

Participants enrolled in Part 2 will be randomly assigned to one of 2 treatment groups:

  • Group 1: Trastuzumab emtansine (dose selected at the end of Part 1)
  • Group 2: Either docetaxel every 21 days or paclitaxel weekly (selected by physician)

Participants may remain on study treatment as long as they are responding to treatment and not experiencing unacceptable side effects.

Disease Status and/or Stage

Advanced or Metastatic HER2-Positive Gastric or GEJ Cancer

Sponsor

Hoffmann-La Roche/Genentech

Key Eligibility

  • Advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) cancer
  • Had disease progression during or after first-line therapy
  • Must have received at least one prior chemotherapy regimen for advanced gastric cancer
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Manish Shah, MD

Contact

Protocol ID

BO27952

Healthy Volunteers

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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