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Expanded Access to Provide Copanlisib for Patients With Cancer Who Are Experiencing a Positive Response, as Determined by Their Doctors

NCT06238583 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2024-02-02

No results posted yet for this study

Summary

The purpose of this Expanded Access Program (EAP) is to allow patients to continue receiving treatment with copanlisib if they are currently having, in the opinion of their healthcare provider, an objective favorable response when taking copanlisib. Patients considering this access program should have no other therapeutic option, have not developed a disease and/or medical condition (including pregnancy), and/or have a toxicity that would conflict with continuing to receive copanlisib.

Conditions

Interventions

DRUG

Copanlisib (Aliqopa, BAY80-6946)

Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The recommended dose of copanlisib is 60 mg administered as a 1 hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day treatment cycle on an intermittent schedule (3 weeks on and 1 week off), OR at a lower dose if dose reduction has occurred on prior treatment. Patients currently included on study protocols may continue their treatment regimen at the discretion of their healthcare provider.

Sponsors & Collaborators

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Brazil
  • Chile
  • Hong Kong
  • Hungary
  • Ireland
  • Malaysia
  • Poland
  • Romania
  • Russia
  • Taiwan
  • Ukraine

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06238583 on ClinicalTrials.gov