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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003769-32 | EudraCT Number |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | RP6530 administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP6530 | Drug | Escalating doses starting at 25 mg BID |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530 |
| 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response following administration of RP6530 | Overall response rate (ORR) and duration of response (DOR). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrés JM Ferreri, MD | Ospedale San Raffaele s.r.l. | Study Chair |
| Carmelo Carlo-stella, MD | Humanitas Clinical and Research Centre | Principal Investigator |
| Richard Delarue, MD | Hopital Necker-Enfants Malades | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhizen Trial Site | Paris | France | ||||
| Rhizen Trial Site 1 |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C000706530 | tenalisib |
| D019869 | Phosphatidylinositol 3-Kinases |
| ID | Term |
|---|---|
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
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| Milan |
| Italy |
| Rhizen Trial Site 2 | Milan | Italy |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D045762 |
| Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |