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Study has been stopped after reviewing PK and safety results
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A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas
Safety: Treatment-Emergent Adverse Events (AE); Treatment related AE, Serious Adverse Events (SAE) and Clinical significant AE; Dose Limiting Toxicities (DLT).
Pharmacokinetics (PK): Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum Concentration Observed (Tmax).
Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS); Overall Survival (OS) and duration of Response (DoR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | RP4010 to be administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP4010 | Drug | Escalating doses starting at 25 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) Determination | To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax). | To assess the Maximum Plasma Concentration (Cmax). | 24 hrs |
| Area under the curve (AUC) | To assess the Area under the plasma concentration versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-3300 | United States | ||
| City of Hope |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000716749 | RP4010 |
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| 24 hrs |
| Anti-tumor activity-Overall response rate (ORR) | To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR) | 2 months |
| Duarte |
| California |
| 91010 |
| United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| St Vincent's Hospital | Sydney | New South Wales | 2010 | Australia |
| Pindara Private Hospital | Benowa | Queensland | 4217 | Australia |
| Brisbane Clinic for Lymphoma, Myeloma and Leukaemia | Greenslopes | Queensland | 4120 | Australia |
| Epworth HealthCare | Richmond | Victoria | 3121 | Australia |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |