Compassionate Use Study of Tenalisib (RP6530)

Sponsor

Rhizen Pharmaceuticals SA (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03711604

Collaborator

(none)

Enrollment

Locations

Arm

48.1

Anticipated Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Malignancies	Drug: Tenalisib	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 28, 2018

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tenalisib Participants receive Tenalisib (RP6530) BID Orally	Drug: Tenalisib BID Orally Other Names: RP6530

Arm

Intervention/Treatment

Experimental: Tenalisib

Participants receive Tenalisib (RP6530) BID Orally

Drug: Tenalisib

BID Orally

Other Names:

RP6530

Outcome Measures

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [2 years]
To evaluate the safety and tolerability of Tenalisib as single agent
Time to disease progression [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Hellen Diller Family Comprehensive Cancer Center	San Francisco	California	United States	94143
2	Division of Hematology, University of Colorado,	Denver	Colorado	United States	80045
3	Cleveland Clinic Taussig Cancer Institute	Cleveland	Ohio	United States	44195
4	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
5	Ltd. M.Zodelava Hematology Centre	Tbilisi		Georgia
6	Medivest - Institute of Hematology and Transfusiology	Tbilisi		Georgia
7	Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.	Chorzów		Poland	41-503