Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies (PI3K)
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ClinicalTrials.gov Identifier: NCT02017613 |
Recruitment Status :
Completed
First Posted : December 23, 2013
Last Update Posted : June 24, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lymphoma, B-Cell T-Cell Lymphoma | Drug: RP6530 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | May 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Single arm
RP6530 administered orally
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Drug: RP6530
Escalating doses starting at 25 mg BID
Other Name: PI3k Delta/ Gamma inhibitor |
- 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.
- Clinical response following administration of RP6530 [ Time Frame: 8 weeks ]Overall response rate (ORR) and duration of response (DOR).

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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:
- 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.
Exclusion Criteria:
- 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.).
- 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.

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): NCT02017613
France | |
Rhizen Trial Site | |
Paris, France | |
Italy | |
Rhizen Trial Site 1 | |
Milano, Italy | |
Rhizen Trial Site 2 | |
Milano, Italy |
Study Chair: | Andrés JM Ferreri, MD | Ospedale San Raffaele s.r.l. | |
Principal Investigator: | Carmelo Carlo-stella, MD | Humanitas Clinical and Research Centre | |
Principal Investigator: | Richard Delarue, MD | Hopital Necker-Enfants Malades |
Responsible Party: | Rhizen Pharmaceuticals SA |
ClinicalTrials.gov Identifier: | NCT02017613 |
Other Study ID Numbers: |
RP6530-1301 2013-003769-32 ( EudraCT Number ) |
First Posted: | December 23, 2013 Key Record Dates |
Last Update Posted: | June 24, 2016 |
Last Verified: | February 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
CLL, SLL, NHL, SLL, PTCL, CTCL, MM, AML |
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |