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
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, B-Cell T-Cell Lymphoma||Drug: RP6530||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Single arm
RP6530 administered orally
Escalating doses starting at 25 mg BID
Other Name: PI3k Delta/ Gamma inhibitor
- 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.
- Clinical response following administration of RP6530 [ Time Frame: 8 weeks ]Overall response rate (ORR) and duration of response (DOR).
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
|Rhizen Trial Site|
|Rhizen Trial Site 1|
|Rhizen Trial Site 2|
|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|