Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

MOUNTAINEER-02 : A Randomized, Double-blind, Placebo-controlled, Active Comparator Phase 2/3 Study of Tucatinib in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Subjects With Previously Treated, Locally-advanced Unresectable or Metastatic HER2+ Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)

Male or<br/>FemaleGender Male or
Female

Closed (no longer recruiting)Status Closed (no longer recruiting)

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

Two/ThreePhase Two/Three

18+Age Over 18

Stomach<br/>CancersCancer LocationStomach
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractGastro-oesophageal junction ,Oesophagus,Stomach

Trial Overview Read MoreRead more

This phase II/III study is trying to understand whether a combined treatment of three targeted therapies (tucatinib, trastuzumab and ramucirumab) and chemotherapy (paclitaxel), works better than one targeted therapy (ramucirumab) and chemotherapy (paclitaxel) to treat HER-2 positive cancers of the stomach and oesophagus.
 

This trial is treating patients with locally advanced or metastatic cancers of the stomach and oesophagus.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Randomized, Double-blind, Placebo-controlled, Active Comparator Phase 2/3 Study of Tucatinib in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Subjects With Previously Treated, Locally-advanced Unresectable or Metastatic HER2+ Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)

Commercial Sponsor

Seagen Inc.

Summary

In the Phase 2 part of the trial, participants and their doctors will know what drugs are being given (open-label). In the Phase 3 part, the study is "blinded." This means that participants, their doctor, and the study sponsor will not know which drugs are being given. Participants will be randomised into one of four arms. In the Phase 2 Arm (experimental), participants will receive tucatinib + trastuzumab + ramucirumab + paclitaxel. Tucatinib will be administered orally, twice daily at a dose of 300mg. Trastuzumab will be administered intravenously (via IV) at a dose of 6mg/kg on Cycle 1 Day 1, followed by 4mg/kg on Cycle 1 Day 15 and then Days 1 and 15 of each cycle thereafter. Ramucirumab will be administered via IV at a dose of 8mg/kg on Days 1 and 15 of each cycle. Paclitaxel will be administered via IV at a dose of 60 or 80mg/m^2 on Days 1, 8 and 15 of each cycle. In Phase 3 Arm A (experimental), participants will also receive tucatinib + trastuzumab + ramucirumab + paclitaxel, all administered the same as the Phase 2 Arm. In Phase 3 Arm B (active comparator), participants will receive Ramucirumab + paclitaxel + tucatinib placebo + trastuzumab placebo. Ramucirumab will be administered via IV at a dose of 8mg/kg on Days 1 and 15 of each cycle. Paclitaxel will be administered at a dose of 60 or 80mg/m^2 via IV on days 1, 8 and 15 of each cycle. The tucatinib placebo will be given twice daily, orally, and the trastuzumab placebo will be given via IV on Days 1 and 15 of each cycle. In Phase 3 Arm C (experimental), participants will receive Tucatinib + ramucirumab + paclitaxel + trastuzumab placebo. Tucatinib will be given twice daily, orally, at a dose of 300mg. Ramucirumab will be administered via IV at a dose of 8mg/kg on Days 1 and 15 of each cycle. Paclitaxel will be administered via IV at a dose of 60 or 80 on Days 1, 8 and 15 of each cycle. The Trastuzumab placebo will be given via IV on Days 1 and 15 of each cycle.

Not Recruiting Hospitals Read MoreRead more

Closed

Austin Health
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

Next