Tucatinib and other cancer drugs in pretreated HER2+ gastric cancer

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  1003948

• Contact name

  Suzanne McGoldrick

• Contact email

  EU-Regulatory@seagen.com

• Sponsor organisation

  Seagen Inc.

• Eudract number

  2020-003249-12

• Clinicaltrials.gov Identifier

  NCT04499924

• Research summary

  Summary of Research
  This clinical study proposes evaluation of tucatinib, trastuzumab, ramucirumab, and paclitaxel for patients with HER2 overexpressing or amplified gastric cancers. The safety profile of tucatinib combined with trastuzumab is understood through previous clinical experience in different tumour types. A cautious initial evaluation of the safety and tolerability of tucatinib and trastuzumab combined with ramucirumab and paclitaxel will be undertaken. The potential benefit of the combination outweighs the risks, and evaluation of this combination is expected to provide opportunity for clinical benefit in the study population.

  Summary of Results
  Please see link to Plain Language Study Summary Results posted on Pfizer.com.
  https://www.pfizer.com/node/561192

• REC name

  Wales REC 2

• REC reference

  21/WA/0265

• Date of REC Opinion

  5 Oct 2021

• REC opinion

  Further Information Favourable Opinion