Compassionate Use Study of Tenalisib (RP6530)
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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
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Condition or disease | Intervention/treatment | Phase |
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Hematological Malignancies | Drug: Tenalisib | Phase 1 Phase 2 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Tenalisib
Participants receive Tenalisib (RP6530) BID Orally
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Drug: Tenalisib
BID Orally
Other Name: RP6530 |
- 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
- Time to disease progression [ Time Frame: 2 years ]

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

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
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hematological Malignancies Tenalisib RP6530 Compassionate Use |
Neoplasms Hematologic Neoplasms Neoplasms by Site Hematologic Diseases |