Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies

Lymphoma, B-Cell Clinical Trial

— PI3K  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017613
• Other study ID #: RP6530-1301
• Secondary ID: 2013-003769-32
• Status: Completed
• Phase: Phase 1
• First received: November 26, 2013
• Last updated: June 23, 2016
• Start date: November 2013
• Est. completion date: May 2016

Study information

• Verified date: February 2016
• Source: Rhizen Pharmaceuticals SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, T-Cell
• T-Cell Lymphoma

Intervention

Drug:
• RP6530
Escalating doses starting at 25 mg BID

Locations

Country	Name	City	State
France	Rhizen Trial Site	Paris
Italy	Rhizen Trial Site 1	Milano
Italy	Rhizen Trial Site 2	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Rhizen Pharmaceuticals SA

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days	Yes
Secondary	Clinical response following administration of RP6530	Overall response rate (ORR) and duration of response (DOR).	8 weeks	No