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Compassionate Use Study of Tenalisib (RP6530)

Primary Purpose

Hematological Malignancies

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tenalisib
Sponsored by
Rhizen Pharmaceuticals SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematological Malignancies focused on measuring Hematological Malignancies, Tenalisib, RP6530, Compassionate Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Hellen Diller Family Comprehensive Cancer Center
  • Division of Hematology, University of Colorado,
  • Cleveland Clinic Taussig Cancer Institute
  • The University of Texas MD Anderson Cancer Center
  • Ltd. M.Zodelava Hematology Centre
  • Medivest - Institute of Hematology and Transfusiology
  • Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tenalisib

Arm Description

Participants receive Tenalisib (RP6530) BID Orally

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 15, 2018
Last Updated
May 16, 2023
Sponsor
Rhizen Pharmaceuticals SA
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1. Study Identification

Unique Protocol Identification Number
NCT03711604
Brief Title
Compassionate Use Study of Tenalisib (RP6530)
Official Title
An Open Label, Compassionate Use Study of Tenalisib (RP6530) in Patients Currently Receiving Treatment on Tenalisib Trials in Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
March 25, 2023 (Actual)
Study Completion Date
March 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhizen Pharmaceuticals SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancies
Keywords
Hematological Malignancies, Tenalisib, RP6530, Compassionate Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tenalisib
Arm Type
Experimental
Arm Description
Participants receive Tenalisib (RP6530) BID Orally
Intervention Type
Drug
Intervention Name(s)
Tenalisib
Other Intervention Name(s)
RP6530
Intervention Description
BID Orally
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
To evaluate the safety and tolerability of Tenalisib as single agent
Time Frame
2 years
Title
Time to disease progression
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of California, Hellen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Division of Hematology, University of Colorado,
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Ltd. M.Zodelava Hematology Centre
City
Tbilisi
Country
Georgia
Facility Name
Medivest - Institute of Hematology and Transfusiology
City
Tbilisi
Country
Georgia
Facility Name
Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.
City
Chorzów
ZIP/Postal Code
41-503
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Compassionate Use Study of Tenalisib (RP6530)

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