Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

Tenalisib has been evaluated as an investigational new drug in number of early clinical studies in patients with relapsed/refractory hematological malignancies and demonstrated acceptable safety and promising efficacy in these patients. Since these advanced relapsed/refractory patients have limited therapeutic options, it is reasonable to continue Tenalisib in responding patients post completion of their participation in previous clinical studies.

Official Title

An Open Label, Compassionate Use Study of Tenalisib (RP6530) in Patients Currently Receiving Treatment on Tenalisib Trials in Hematological Malignancies

Keywords

Hematological Malignancies Tenalisib RP6530 Compassionate Use Hematologic Neoplasms Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patients must be currently receiving treatment with Tenalisib on a previously approved protocol.
  2. Patients must have had at least one efficacy evaluation in previous study and should have achieved either SD, PR or CR.
  3. Patients must have completed at least 6 cycles of Tenalisib in previous study
  4. Ability to swallow and retain oral medication.
  5. Female patients of child-bearing potential must consent to use two medically acceptable methods of contraception.
  6. Male patients must be willing to use adequate contraceptive measures
  7. Willingness and ability to comply with trial and follow-up procedures.
  8. Willingness to provide new written informed consent.

You CAN'T join if...

  1. Patient has been discontinued from their previous Tenalisib study 4 weeks prior to entering the compassionate use trial.
  2. Patient progressed while receiving Tenalisib therapy in his/her previous study.
  3. Pregnant or lactating woman.
  4. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
  5. Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.

Locations

  • University of California, Hellen Diller Family Comprehensive Cancer Center
    San Francisco California 94143 United States
  • Division of Hematology, University of Colorado,
    Denver Colorado 80045 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Rhizen Pharmaceuticals SA
ID
NCT03711604
Phase
Phase 1/2
Study Type
Interventional
Last Updated