Compassionate Use Study of Tenalisib (RP6530)

Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711604
• Other study ID #: RP6530-1803
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 28, 2018
• Est. completion date: March 25, 2023

Study information

• Verified date: April 2024
• Source: Rhizen Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 25, 2023
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematological Malignancies
• Neoplasms

Intervention

Drug:
• Tenalisib
BID Orally

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Rhizen Pharmaceuticals SA

Countries where clinical trial is conducted

United States,  Georgia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related Adverse Events	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	2 years
Primary	Time to Disease Progression	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.	2 years