Open Actively Recruiting

Expanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib

About

Brief Summary

This expanded access program will provide continued access to cerdulatinib to eligible participants who experienced clinical benefit from cerdulatinib in Study 13-601 (NCT01994382) and who otherwise meet the eligibility criteria.

Study Type
Expanded Access
Phase
N/A

Eligibility

Gender
All
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Participant has completed Portola Study 13-601 and wishes to continue treatment with cerdulatinib.
  • In the opinion of the Investigator, the potential benefit to the participant of continuing to receive cerdulatinib outweighs the risks.
  • Female participants of childbearing potential and male participants must agree to continue to abstain from sexual intercourse or to remain on an effective method of contraception during treatment and for 90 days following the last dose of protocol therapy (examples of effective methods of contraception include oral contraceptives or double barrier methods, such as condom plus spermicide or condom plus diaphragm).
  • Participant must be willing to give written informed consent and be able to adhere to dose and visit schedules.

Exclusion Criteria:

  • Participant requires chronic treatment with a strong CYP3A4 inhibitor or inducer.
  • Participant has a known hypersensitivity to any of the components of cerdulatinib.
  • Participant is female and is breast-feeding, pregnant, or intends to become pregnant.
  • Participant is participating in any therapeutic clinical study.

Join this Trial

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Study Stats
Protocol No.
20-001370
Category
Hematology-Oncology
Oncology
Principal Investigator
Contact
Shenetra Walker
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04757259
For detailed technical eligibility, visit ClinicalTrials.gov.