Lymphoma, B-CellPhase 1PI3KNCT02017613
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies
A Phase 1 study testing RP6530 in people with Lymphoma, B-Cell and T-Cell Lymphoma, run by Rhizen Pharmaceuticals SA at 3 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, B-Cell, T-Cell Lymphoma
- 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
- 35 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2013to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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 4 weeks or limited palliative radiation <2 weeks
- Patients with HBV, HCV or HIV infection
- Autologous hematologic stem cell transplant within 3 months of study entry. Allogeneic hematologic stem cell transplant within 12 months.
- Previous therapy with GS-1101 (CAL-101, idelalisib), IPI-145, TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib).
- Patients on immunosuppressive therapy including systemic corticosteroids.
- Patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.).
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- 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
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Phase I, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K Delta/Gamma Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies
The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies.
Read the detailed description
The Maximum tolerated dose (MTD) will be determined based on the safety, pharmacokinetic (PK) and efficacy data. Safety analyses include AE's, AE's related to the drug, SAE's, laboratory values, vitals/ ECG and dose limiting toxicity (DLT). PK include measurement of peak plasma concentration (Cmax), area under the plasma concentration versus the time curve (AUC), time of maximum concentration observed (Tmax). Efficacy analyses include overall response rate (ORR) and duration of response (DOR).
- Conditions
- Lymphoma, B-Cell, T-Cell Lymphoma
- Being tested
- RP6530
- Keywords
- CLL, SLL, NHL, SLL, PTCL, CTCL, MM, AML
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, T-Cell, Lymphoma, Non-Hodgkin, Lymphoma, T-Cell, Cutaneous, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP6530Drug
Also called PI3k Delta/ Gamma inhibitor
Escalating doses starting at 25 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | RP6530 administered orally Receives: Drug: RP6530 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530
- To access maximum tolerated dose by clinical laboratory assessments, adverse events and dose limiting toxicities.
- PK parameter AUC, Cmax, tmax, t1/2 will be determined.
Measured: 28 days
Secondary outcomes (1)
Clinical response following administration of RP6530
Overall response rate (ORR) and duration of response (DOR).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrés JM Ferreri, MD, Study chair, Ospedale San Raffaele s.r.l.Carmelo Carlo-stella, MD, Principal investigator, Humanitas Clinical and Research CentreRichard Delarue, MD, Principal investigator, Hopital Necker-Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02017613
- Sponsor's protocol ID
- RP6530-1301
- Other IDs
- 2013-003769-32
- Acronym
- PI3K
- Status last verified
- Feb 2016
- First submitted
- 26 Nov 2013
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K Delta/Gamma Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02017613
- Acronym / sponsor ID
- PI3K / RP6530-1301
- Conditions
- Lymphoma, B-Cell, T-Cell Lymphoma
- Keywords
- CLL, SLL, NHL, SLL, PTCL, CTCL, MM, AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies.
Detailed description
The Maximum tolerated dose (MTD) will be determined based on the safety, pharmacokinetic (PK) and efficacy data. Safety analyses include AE's, AE's related to the drug, SAE's, laboratory values, vitals/ ECG and dose limiting toxicity (DLT). PK include measurement of peak plasma concentration (Cmax), area under the plasma concentration versus the time curve (AUC), time of maximum concentration observed (Tmax). Efficacy analyses include overall response rate (ORR) and duration of response (DOR).
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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (10 listed)
- Any cancer therapy in the last 4 weeks or limited palliative radiation <2 weeks
- Patients with HBV, HCV or HIV infection
- Autologous hematologic stem cell transplant within 3 months of study entry. Allogeneic hematologic stem cell transplant within 12 months.
- Previous therapy with GS-1101 (CAL-101, idelalisib), IPI-145, TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib).
- Patients on immunosuppressive therapy including systemic corticosteroids.
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 Delta/ Gamma inhibitorEscalating doses starting at 25 mg BID | Drug | Single arm |
Primary outcome
Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530
Time frame: 28 days
* To access maximum tolerated dose by clinical laboratory assessments, adverse events and dose limiting toxicities. * PK parameter AUC, Cmax, tmax, t1/2 will be determined.
1 secondary outcome
Clinical response following administration of RP6530
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- 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.
Andrés JM Ferreri, MD study chair
Ospedale San Raffaele s.r.l.
Carmelo Carlo-stella, MD principal investigator
Humanitas Clinical and Research Centre
Richard Delarue, MD principal investigator
Hopital Necker-Enfants Malades
3 sites in 2 countries: 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, B-Cell and T-Cell Lymphoma, run by Rhizen Pharmaceuticals SA at 3 sites in 2 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 4 inclusion and 10 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 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum tolerated dose (MTD) and pharmacokinetics (PK) 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 24 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.