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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
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell T-Cell Lymphoma Drug: RP6530 Phase 1

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
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm
RP6530 administered orally
 Drug: RP6530
Escalating doses starting at 25 mg BID
Other Name: PI3k Delta/ Gamma inhibitor


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical response following administration of RP6530 [ Time Frame: 8 weeks ]
    Overall response rate (ORR) and duration of response (DOR).


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

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
Rhizen Trial Site
Paris, France
Italy
Rhizen Trial Site 1
Milano, Italy
Rhizen Trial Site 2
Milano, Italy
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
Investigators
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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
More Information
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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
Keywords provided by Rhizen Pharmaceuticals SA:
CLL, SLL, NHL, SLL, PTCL, CTCL, MM, AML
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin