NCT02017613

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2013

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 24, 2016

Status Verified

February 1, 2016

Enrollment Period

2.5 years

First QC Date

November 26, 2013

Last Update Submit

June 23, 2016

Conditions

Lymphoma, B-CellT-Cell Lymphoma

Keywords

CLL, SLL, NHL, SLL, PTCL, CTCL, MM, AML

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD) and pharmacokinetics (PK) of RP6530

    * To access maximum tolerated dose by clinical laboratory assessments, adverse events and dose limiting toxicities. * PK parameter AUC, Cmax, tmax, t1/2 will be determined.

    28 days

Secondary Outcomes (1)

  • Clinical response following administration of RP6530

    8 weeks

Study Arms (1)

Single arm

EXPERIMENTAL

RP6530 administered orally

Drug: RP6530

Interventions

RP6530DRUG

Escalating doses starting at 25 mg BID

Also known as: PI3k Delta/ Gamma inhibitor
Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Any cancer therapy in the last 4 weeks or limited palliative radiation \<2 weeks
  • Patients with HBV, HCV or HIV infection
  • Autologous hematologic stem cell transplant within 3 months of study entry. Allogeneic hematologic stem cell transplant within 12 months.
  • Previous therapy with GS-1101 (CAL-101, idelalisib), IPI-145, TGR-1202 or any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib).
  • Patients on immunosuppressive therapy including systemic corticosteroids.
  • Patients who are receiving chronic systemic anticoagulation therapy (warfarin sodium or heparin, etc.).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rhizen Trial Site

Paris, France

Location

Rhizen Trial Site 1

Milan, Italy

Location

Rhizen Trial Site 2

Milan, Italy

Location

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma, T-CellLymphoma, Non-HodgkinLymphoma, T-Cell, CutaneousLeukemia, Myeloid, Acute

Interventions

tenalisibPhosphatidylinositol 3-Kinases

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidLeukemiaHematologic Diseases

Intervention Hierarchy (Ancestors)

Phosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 23, 2013

Study Start

November 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 24, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)IT(2)