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Studies

Interventional Active not recruiting Phase 2

NCT04579380 on ClinicalTrials.gov

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Official title: A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations

  • Sponsor: Seagen France SAS
  • Enrollment: 217 (Actual)
  • Study start: 2021-01-11 (Actual)
  • Primary completion: 2023-11-01 (Actual)
  • Study completion: 2026-12-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

This trial studies how well tucatinib works for solid tumors that make either more HER2 or a different type of HER2 than usual (HER2 alterations) The solid tumors studied in this trial have either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable).

All participants will get both tucatinib and trastuzumab. People with hormone-receptor positive breast cancer will also get a drug called fulvestrant.

The trial will also look at what side effects happen. A side effect is anything a drug does besides treating cancer.

Conditions

  • Uterine Neoplasms
  • Uterine Cervical Neoplasms
  • Biliary Tract Neoplasms
  • Urologic Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • HER2 Mutations Breast Neoplasms

Intervention / Treatment

  • Drug: tucatinib
  • Drug: trastuzumab
  • Drug: fulvestrant

Primary Outcome Measures

  • Confirmed Objective Response Rate (cORR) as Assessed by Investigator (From the first dose of study treatment until the first documented CR or PR on or before the first documented PD or new anti-cancer therapies or death, whichever occurred first (up to 28.3 months))
    Confirmed ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version (v)1.1 as assessed by investigator and was considered as confirmed when subsequent response was at least 4 weeks after initial response. As per RECIST v1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeter (mm). PR: at least a greater than or equal to (\>=)30 % decrease in the sum of diameters (SOD) of target lesions (longest for non-nodal target lesions and the short axes for nodal target lesions), taking as reference the baseline sum diameters. Disease progression (PD): at least \>=20% relative increase in SOD of target lesion taking as reference the smallest sum on study (including baseline sum if that is the smallest on study).

Countries

Belgium, Germany, Italy, Japan, South Korea, Spain, United Kingdom, United States

Locations and Investigators

  • Cliniques Universitaires Saint-Luc, Sint-Lambrechts-Woluwe, Belgium
    • Cedric, Van Marcke De Lummen
  • Antwerp University Hospital, Edegem, Belgium
  • Centre hospitalier universitaire de Liege, Liege, Belgium
    • Andree, Rorive
  • Algemeen Ziekenhuis Groeninge, Kortrijk, Belgium
    • Philip, Debruyne
  • Grand Hopital De Charleroi, Charleroi, Belgium
    • Jean-Luc, Canon
  • Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA, Valencia, Spain
    • Valentina, Gambardella
  • Institut Catala D'oncologia, L'hospitalet De Llobregat, Spain
    • Marta, Gil Martin
  • Charite Universitaetsmedizin Berlin KöR, Berlin, Germany
    • Antonia, Busse

Study Officials

  • Pfizer CT.gov Call Center (Study Director) — Pfizer