Hematological MalignanciesPhase 1/2NCT03711604
Compassionate Use Study of Tenalisib (RP6530)
A Phase 1/2 study testing Tenalisib in people with Hematological Malignancies, run by Rhizen Pharmaceuticals SA at 7 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- Tenalisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 28 Nov 2018to 25 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States4 sites
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, 44195
Division of Hematology, University of Colorado,
Denver, Colorado, 80045
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of California, Hellen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
Georgia2 sites
Ltd. M.Zodelava Hematology Centre
Tbilisi
Medivest - Institute of Hematology and Transfusiology
Tbilisi
Poland1 site
Silesian Healthy Blood Clinic Grosicki, Grosicka Sp.J.
Chorzów, 41-503
About this study
Official title: An Open Label, Compassionate Use Study of Tenalisib (RP6530) in Patients Currently Receiving Treatment on Tenalisib Trials in Hematological Malignancies
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.
- Conditions
- Hematological Malignancies
- Being tested
- Tenalisib
- Keywords
- Hematological Malignancies, Tenalisib, RP6530, Compassionate Use
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenalisibDrug
Also called RP6530
BID Orally
| Study group | Role | What they receive |
|---|---|---|
| Tenalisib | Experimental | Participants receive Tenalisib (RP6530) BID Orally Receives: Drug: Tenalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start28 Nov 2018
- Primary completion25 Mar 2023
- Study completion25 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711604
- Sponsor's protocol ID
- RP6530-1803
- Status last verified
- Apr 2024
- First submitted
- 15 Oct 2018
- Last updated
- 8 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Compassionate Use Study of Tenalisib (RP6530) in Patients Currently Receiving Treatment on Tenalisib Trials in Hematological Malignancies
- ClinicalTrials.gov ID
- NCT03711604
- Acronym / sponsor ID
- RP6530-1803
- Conditions
- Hematological Malignancies
- Keywords
- Hematological Malignancies, Tenalisib, RP6530, Compassionate Use
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Posted 8 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tenalisib | Experimental | Drug: TenalisibParticipants receive Tenalisib (RP6530) BID Orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenalisibAlso: RP6530BID Orally | Drug | Tenalisib |
Primary outcome
Treatment-related Adverse Events
Time frame: 2 years
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
Time to Disease Progression
Time frame: 2 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tenalisib in people with Hematological Malignancies, run by Rhizen Pharmaceuticals SA at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Georgia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related Adverse Events (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.