Phase 2
Completed N=17
Compassionate Use Study of Tenalisib (RP6530)
Source: ClinicalTrials.gov NCT03711604 ↗Enrolled (actual)
17
Serious AEs
29.4%
Results posted
May 2024
Primary outcomePrimary: Treatment-related Adverse Events — 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-related Adverse Events |
4 | — |
| PRIMARY Time to Disease Progression |
8.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03711604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.