TriangleNCT02567656 · REGISTRY CONDITION SEARCH
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE1
- Status at capture
- COMPLETED
- Registry last update
- 2020-01-13
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Histologically confirmed T cell Non-Hodgkin Lymphoma (T-NHL) * 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 3 weeks or limited palliative radiation \<2 weeks * Patients with HBV, HCV or HIV infection * Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib) in last 6 months * Patients on immunosuppressive therapy including systemic corticosteroids. * 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- RP6530 administered orally twice a day.
- intervention Names
- Drug: RP6530
- label
- Single arm
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Single arm
- description
- Tablet starting at 200 mg
- name
- RP6530
- other Names
- PI3K inhibitor
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 58
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0
- measure
- Safety of RP6530
- time Frame
- 28 days
- secondary Outcomes
- description
- 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).
- measure
- Overall Response Rate (ORR) With RP6530
- time Frame
- 8 months
- description
- The time period from the response achieved in patient until the disease progression.
- measure
- Duration of Response (DOR) With RP6530
- time Frame
- 24 months
- description
- Peak Plasma Concentration (Cmax) of RP6530
- measure
- Peak Plasma Concentration (Cmax)
- time Frame
- Day 1 of Cycle 1
Full study description
- brief Summary
- 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.
- detailed Description
- 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.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-2da171c3e4379aebc07e
- requested nct id
- NCT02567656
- primary nct id
- NCT02567656
- source kind
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- source record id
- Source null
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- e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
- payload sha256
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- payload
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- link basis
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- nct id
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- occurrences
- context exact
- NCT02567656
- end
- 11
- exact text
- NCT02567656
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Peripheral T-Cell Non-Hodgkin Lymphoma
- query disease state id
- ds-peripheral-t-cell-non-hodgkin-lymphoma
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
- source file sha256
- e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
- source json pointer
- /studies/40/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 662bb43c992e113005501b4d973c17343657343c37ac10413d174b2a010304de
Preserved source evidence · Not medical advice