Compassionate Use Study of Tenalisib (RP6530)

Phase 1

Completed

• Conditions: Hematological Malignancies
• Interventions: Drug: Tenalisib

• Registration Number: NCT03711604
• Lead Sponsor: Rhizen Pharmaceuticals SA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-18
• Study Start: 2018-11-28
• Primary Completion: 2023-03-25
• Study Completion: 2023-03-25
• Status Verified: 2024-04
• Results First Submitted: 2024-04-15
• Results First Submitted QC: 2024-04-15
• Last Update Submitted: 2024-04-15
• Results First Posted: 2024-05-08
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tenalisib	Tenalisib	Participants receive Tenalisib (RP6530) BID Orally

Primary Outcome Measures

Name	Time	Method
Treatment-related Adverse Events	2 years	To evaluate the safety and tolerability of Tenalisib as single agent. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time to Disease Progression	2 years	Number of patients with a time to progression. The time to progression is calculated from the day of enrollment in the study to disease progression or death due to any cause.

Trial Locations

Locations (7)

Cleveland Clinic Taussig Cancer Institute; 🇺🇸 Cleveland, Ohio, United States

Ltd. M.Zodelava Hematology Centre; 🇬🇪 Tbilisi, Georgia

Division of Hematology, University of Colorado,; 🇺🇸 Denver, Colorado, United States

University of California, Hellen Diller Family Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.; 🇵🇱 Chorzów, Poland

Medivest - Institute of Hematology and Transfusiology; 🇬🇪 Tbilisi, Georgia