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| ID | Type | Description | Link |
|---|---|---|---|
| 124584 | Other Identifier | Food and Drug Administration |
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The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.
Safety: Treatment-Emergent AE; Treatment-Related AE, SAE and Clinical significant AE; Dose Limiting Toxicities (DLT). 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | RP6530 administered orally twice a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP6530 | Drug | Tablet starting at 200 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of RP6530 | Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) With RP6530 | ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline). | 8 months |
| Duration of Response (DOR) With RP6530 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Auris Huen, MD | MD Anderson Cancer Center, Houston, Tx. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Chao Family Comprehensive Cancer Center University of California Irvine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose escalation_Cohort 1_200 mg | RP6530 administered 200 mg orally twice a day. |
| FG001 | Dose escalation_Cohort 2_400 mg | RP6530 administered 400 mg orally twice a day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 23, 2018 | Oct 25, 2019 |
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The time period from the response achieved in patient until the disease progression. |
| 24 months |
| Peak Plasma Concentration (Cmax) | Peak Plasma Concentration (Cmax) of RP6530 | Day 1 of Cycle 1 |
| Orange |
| California |
| 92868 |
| United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0944 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106-5028 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| FG002 | Dose escalation_Cohort 3_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition |
| FG003 | Dose escalation_Cohort 4_800 mg (Fed) | RP6530 administered 800 mg orally twice a day under fed condition |
| FG004 | Dose expansion_PTCL_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition |
| FG005 | Dose expansion_CTCL_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose escalation_Cohort 1_200 mg | RP6530 administered 200 mg orally twice a day. |
| BG001 | Dose escalation_Cohort 2_400 mg | RP6530 administered 400 mg orally twice a day. |
| BG002 | Dose escalation_Cohort 3_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition |
| BG003 | Dose escalation_Cohort 4_800 mg (Fed) | RP6530 administered 800 mg orally twice a day under fed condition |
| BG004 | Dose expansion_PTCL_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition |
| BG005 | Dose expansion_CTCL_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| Primary | Safety of RP6530 | Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0 | DLT assessment performed in patients who participated in dose escalation phase; A toxicity will be considered dose-limiting if it occurs during the first cycle (4-weeks) treatment with Tenalisib and is considered related to Tenalisib. | Posted | Count of Participants | Participants | 28 days |
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| Secondary | Overall Response Rate (ORR) With RP6530 | ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline). | Patients were considered for efficacy analysis as per protocol only if they had one post treatment efficacy assessment at C3D1 | Posted | Count of Participants | Participants | 8 months |
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| Secondary | Duration of Response (DOR) With RP6530 | The time period from the response achieved in patient until the disease progression. | Duration of Response (DoR) is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. Overall number of Participants analyzed for DoR will be the participants who met response as CR or PR | Posted | Median | Full Range | Days | 24 months |
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| Secondary | Peak Plasma Concentration (Cmax) | Peak Plasma Concentration (Cmax) of RP6530 | Peak Plasma Concentration (Cmax) of RP6530 at Cycle 1 day 1 | Posted | Mean | Standard Deviation | ng/mL | Day 1 of Cycle 1 |
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24 months
Summary of Related Treatment Emergent Adverse Events - All Patients
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose escalation_Cohort 1_200 mg | RP6530 administered 200 mg orally twice a day. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG001 | Dose escalation_Cohort 2_400 mg | RP6530 administered 400 mg orally twice a day. | 1 | 4 | 0 | 4 | 3 | 4 |
| EG002 | Dose escalation_Cohort 3_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition | 1 | 5 | 0 | 5 | 5 | 5 |
| EG003 | Dose escalation_Cohort 4_800 mg (Fed) | RP6530 administered 800 mg orally twice a day under fed condition | 1 | 6 | 0 | 6 | 5 | 6 |
| EG004 | Dose expansion_PTCL_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition | 3 | 19 | 3 | 19 | 11 | 19 |
| EG005 | Dose expansion_CTCL_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition | 1 | 20 | 3 | 20 | 17 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | Gastrointestinal disorders | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | Systematic Assessment |
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| International normalized ratio increased | Investigations | Systematic Assessment |
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| Diplopia | Eye disorders | Systematic Assessment |
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| Sepsis syndrome | Infections and infestations | Systematic Assessment |
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| Skin Infection | Infections and infestations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prajak Barde MD | Rhizen Pharmaceuticals S.A. | +41 32 580 0113 | pjb@rhizen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2018 | Nov 1, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000706530 | tenalisib |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| No.of Participants without Dose Limiting Toxicitie |
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| Dose expansion_PTCL_800 mg (Fasting) |
RP6530 administered 800 mg orally twice a day under fasting condition |
| OG005 | Dose expansion_CTCL_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition |
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| OG004 | Dose expansion_PTCL_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition |
| OG005 | Dose expansion_CTCL_800 mg (Fasting) | RP6530 administered 800 mg orally twice a day under fasting condition |
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| Participants |
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