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Trial record 1 of 1 for:    Compassionate Use Study of Tenalisib (RP6530)
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Compassionate Use Study of Tenalisib (RP6530)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711604
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2018
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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 : November 28, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Tenalisib
Participants receive Tenalisib (RP6530) BID Orally
 Drug: Tenalisib
BID Orally
Other Name: RP6530


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]
    To evaluate the safety and tolerability of Tenalisib as single agent

  2. Time to disease progression [ Time Frame: 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711604


Locations
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United States, California
University of California, Hellen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143
United States, Colorado
Division of Hematology, University of Colorado,
Denver, Colorado, United States, 80045
United States, Ohio
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
United States, Texas
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Georgia
Ltd. M.Zodelava Hematology Centre
Tbilisi, Georgia
Medivest - Institute of Hematology and Transfusiology
Tbilisi, Georgia
Poland
Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.
Chorzów, Poland, 41-503
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
More Information
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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT03711604    
Other Study ID Numbers: RP6530-1803
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhizen Pharmaceuticals SA:
Hematological Malignancies
Tenalisib
RP6530
Compassionate Use
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases