Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies (NCT02017613) | Clinical Trial Compass
CompletedPhase 1
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies
France, Italy35 participantsStarted 2013-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530