Continued Treatment Study for Patients with ALK-Positive or RET-Positive Cancer Using Alectinib or Crizotinib

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03194893

Provider View

This study offers ongoing treatment with the drugs alectinib or crizotinib for patients with ALK- or RET-positive cancer who have previously benefited from these treatments in a related study and cannot switch to commercial supply.

Patient Parameters

Program Overview

The aim of this study is to continue providing the cancer treatments alectinib or crizotinib to patients with ALK- or RET-positive cancer. These patients must have been part of a previous study sponsored by Roche and must have shown positive results from the treatment. This continuation is for those who cannot access the medication through commercial means after the original study ends.

Eligibility Criteria

Inclusion Criteria

  • Must have been part of a Roche-sponsored study using alectinib and shown benefits from alectinib or crizotinib treatment.
  • Must have completed all required data collection for the previous study, including safety and effectiveness information.
  • Women who can become pregnant must agree to use effective birth control or remain abstinent during treatment and for at least 3 months after the last dose.
  • Men must agree to use effective birth control or remain abstinent during treatment and for at least 3 months after the last dose.

Exclusion Criteria

  • No longer benefiting from the treatment in the previous study.
  • Had to stop alectinib or crizotinib permanently during the previous study or before starting this study.
  • Experienced a side effect in the previous study that required stopping the treatment permanently.
  • Pregnant or breastfeeding women cannot participate.
  • Have a serious side effect that hasn't improved to the level it was before starting treatment.
  • Had to stop treatment for more than 21 days due to a side effect since the last dose in the previous study.
  • Taking certain medications that affect how crizotinib works within 14 days before starting this study.
  • Any personal or social issues that might make it hard to follow the study rules or attend follow-up appointments.

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