Lymphoma, T-Cell, PeripheralPhase 1NCT02567656
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
A Phase 1 study testing RP6530 in people with Lymphoma, T-Cell, Peripheral and Lymphoma, T-Cell, Cutaneous, run by Rhizen Pharmaceuticals SA at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous
- What is being tested?
- RP6530
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2015to 10 Dec 2018
- Phase
- Phase 1
- 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
- Histologically confirmed T cell Non-Hodgkin Lymphoma (T-NHL)
- Refractory to or relapsed after at least 1 prior treatment line.
- ECOG performance status ≤2
- Patients must be ≥18 years of age
- Able to give a written informed consent.
Who cannot join
- Any cancer therapy in the last 3 weeks or limited palliative radiation <2 weeks
- Patients with HBV, HCV or HIV infection
- Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib) in last 6 months
- Patients on immunosuppressive therapy including systemic corticosteroids.
- Patients with known history of liver disorders.
- Patients with uncontrolled Diabetes Type I or Type II
- Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
- Women who are pregnant or lactating.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0944
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Colorado Cancer Center
Aurora, Colorado, 80045
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-5028
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
Chao Family Comprehensive Cancer Center University of California Irvine
Orange, California, 92868
About this study
Official title: A Phase I/Ib, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K δ/γ Inhibitor, in Patients With Relapsed or Refractory T-cell Lymphoma
The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.
Read the detailed description
Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities (DLT). PK: Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum concentration observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS) and Duration of Response.
- Being tested
- RP6530
- Keywords
- CTCL, PTCL, RP6530
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP6530Drug
Also called PI3K inhibitor
Tablet starting at 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | RP6530 administered orally twice a day. Receives: Drug: RP6530 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of RP6530
Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
Measured: 28 days
Secondary outcomes (3)
Overall Response Rate (ORR) With RP6530
ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline).
Measured: 8 months
Duration of Response (DOR) With RP6530
The time period from the response achieved in patient until the disease progression.
Measured: 24 months
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of RP6530
Measured: Day 1 of Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2018
- Study completion10 Dec 2018
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 Lymphoma, T-Cell, PeripheralStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Auris Huen, MD, Principal investigator, MD Anderson Cancer Center, Houston, Tx.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567656
- Sponsor's protocol ID
- RP6530-1401
- Other IDs
- 124584
- Status last verified
- Dec 2019
- First submitted
- 3 Sep 2015
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K δ/γ Inhibitor, in Patients With Relapsed or Refractory T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT02567656
- Acronym / sponsor ID
- RP6530-1401
- Keywords
- CTCL, PTCL, RP6530
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.
Detailed description
Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities (DLT). PK: Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum concentration observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS) and Duration of Response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: RP6530RP6530 administered orally twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically confirmed T cell Non-Hodgkin Lymphoma (T-NHL)
- Refractory to or relapsed after at least 1 prior treatment line.
- ECOG performance status ≤2
- Patients must be ≥18 years of age
- Able to give a written informed consent.
Key exclusion criteria (8 listed)
- Any cancer therapy in the last 3 weeks or limited palliative radiation <2 weeks
- Patients with HBV, HCV or HIV infection
- Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib) in last 6 months
- Patients on immunosuppressive therapy including systemic corticosteroids.
- Patients with known history of liver disorders.
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 |
|---|---|---|
| RP6530Also: PI3K inhibitorTablet starting at 200 mg | Drug | Single arm |
Primary outcome
Safety of RP6530
Time frame: 28 days
Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
3 secondary outcomes
Overall Response Rate (ORR) With RP6530
Time frame: 8 months
Duration of Response (DOR) With RP6530
Time frame: 24 months
Peak Plasma Concentration (Cmax)
Time frame: Day 1 of Cycle 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- 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.
Auris Huen, MD principal investigator
MD Anderson Cancer Center, Houston, Tx.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RP6530 in people with Lymphoma, T-Cell, Peripheral and Lymphoma, T-Cell, Cutaneous, run by Rhizen Pharmaceuticals SA at 8 sites in United States.
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 5 inclusion and 8 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 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.
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 13 Jan 2020). 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?
Safety of RP6530 (time frame: 28 days). 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 13 Jan 2020.