Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies
Conditions
Lymphoma, B-Cell - T-Cell Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, B-Cell - Lymphoma, T-Cell
Conditions: Keywords
CLL, SLL, NHL, SLL, PTCL, CTCL, MM, AML
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: RP6530
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Location
Rhizen Trial Site
Milano, Italy
Status: Recruiting
Contact: Rhizen Trial Site, Milano
Start Date
November 2013
Completion Date
November 2015
Sponsors
Rhizen Pharmaceuticals SA
Source
Rhizen Pharmaceuticals SA
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page