Clinical trial · Interventional
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in Hematological Malignancies
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
NCT02017613CI-TRIAL-00022715PI3KcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| T-Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RP6530 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- RP6530 administered orally
- interventionNames
- Drug: RP6530
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530
- timeFrame
- 28 days
- description
- * 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 outcomes (1)
- measure
- Clinical response following administration of RP6530
- timeFrame
- 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.