Compassionate Use Study of Tenalisib (RP6530)

Completed · Phase 1/Phase 2

Conditions studied: Hematological Malignancies

In brief

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.

Key facts

Study ID

NCT03711604

Run by

Rhizen Pharmaceuticals SA

People needed

17

Starts

2018-11-28

Expected to finish

2023-03-25

Last updated by the study team

2024-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• University of California, Hellen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Division of Hematology, University of Colorado, — Denver, Colorado, United States
• Cleveland Clinic Taussig Cancer Institute — Cleveland, Ohio, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Ltd. M.Zodelava Hematology Centre — Tbilisi, Georgia
• Medivest - Institute of Hematology and Transfusiology — Tbilisi, Georgia
• Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J. — Chorzów, Poland

Full record on ClinicalTrials.gov

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