Continued access to treatment for patients with advanced cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter rollover study aims to provide ongoing treatment for participants who have shown clinical benefit from previous therapies sponsored by Daiichi Sankyo or AstraZeneca. The study includes various sub-protocols for different study drugs, focusing on the long-term safety and efficacy of T-DXd in patients with advanced or metastatic cancer. Participants must be currently enrolled in a parent study and demonstrate no evidence of disease progression to qualify for continued treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for enrollment into the study:

1. Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.
2. No evidence of progressive disease at screening and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).
3. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug.

   a. If the participant is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug.
4. Male subjects must not freeze or donate sperm starting at Screening, throughout the study period, and at least 4 months after the final study drug administration.
5. Female subjects must not donate, or retrieve for their own use, ova from the time of Screening, and throughout the Treatment Period in the compound-specific sub-protocol and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time.

Exclusion Criteria:

Participants who meet any of the following criteria will be disqualified from entering the study:

1. Participants who permanently discontinued from the study drug in the parent study.
2. Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the investigator, indicates study participation is not in the best interest of the subject.
3. Local access to commercially available drug at no cost to the subject as permitted by local/country regulation.

Where it's running

• Research Facility
  Hefei, China Recruiting
• Research Facility
  Miami, Florida, United States Active not recruiting
• Research Facility
  Durham, North Carolina, United States Active not recruiting
• Research Facility
  Bedford Park, Australia Active not recruiting
• Research Facility
  Itajaí, Brazil Active not recruiting
• Research Facility
  Rio de Janeiro, Brazil Active not recruiting

Study contacts

• Study coordinator: Daiichi Sankyo Contact for Clinical Trial Information
• Email: CTRinfo_us@daiichisankyo.com
• Phone: 908-992-6400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.