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Completed

NCT Number: NCT02567656

Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma

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.

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Key information

Conditions

Lymphoma, T-Cell, Peripheral Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RP6530

Drug

Tablet starting at 200 mg

Other names: PI3K inhibitor

Primary outcomes

  1. Safety of RP6530

    Time frame: 28 days

    Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0

Secondary outcomes

  1. Overall Response Rate (ORR) With RP6530

    Time frame: 8 months

    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).

  2. Duration of Response (DOR) With RP6530

    Time frame: 24 months

    The time period from the response achieved in patient until the disease progression.

  3. Peak Plasma Concentration (Cmax)

    Time frame: Day 1 of Cycle 1

    Peak Plasma Concentration (Cmax) of RP6530

Sponsors and collaborators

Lead sponsor

Rhizen Pharmaceuticals SA

Industry

Registry information

Official study title

A Phase I/Ib, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K δ/γ Inhibitor, in Patients With Relapsed or Refractory T-cell Lymphoma

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2015
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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