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NCT04068597PHASE1, PHASE2Recruiting

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

CellCentric Ltd.

Start Date

8/9/2019

Completion Date

3/31/2027

Summary

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

Detailed Description

This includes patients with Peripheral T-cell lymphoma.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Provision of consent * ECOG performance status 0-2 * Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML) * Must have previously received standard therapy * Adequate organ function Exclusion Criteria: * Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose * Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment * Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment * Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment * Patients should discontinue statins prior to starting study treatment * CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment * Any unresolved reversible toxicities from prior therapy \>CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy) * Any evidence of severe or uncontrolled systemic diseases * Any known uncontrolled inter-current illness * QTcF prolongation (\> 470 msec)

Interventions

DRUG

CCS1477

DRUG

Pomalidomide

DRUG

Dexamethasone

DRUG

Azacitidine

DRUG

Venetoclax

DRUG

Bortezomib

DRUG

Ixazomib

DRUG

Elranatamab

DRUG

Teclistamab

DRUG

Lenalidomide

DRUG

Daratumumab

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Conditions

Haematological MalignancyAcute Myeloid LeukemiaNon Hodgkin LymphomaMultiple MyelomaHigher-risk Myelodysplastic SyndromePeripheral T Cell Lymphoma

Locations

Emory Winship Cancer Institute

Atlanta, Georgia 30322

United States

Community Health Network

Indianapolis, Indiana 46227

United States

The Center for Cancer and Blood Disorders (CCBD)

Bethesda, Maryland 20817

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198-6846

United States

Penn Medicine - Abramson Cancer Center Perelman

Philadelphia, Pennsylvania 19104

United States

Institute Bergonie

Bordeaux, 33076

France

Gustave Roussy

Villejuif, 94805

France

Hospital Germans Trias i Pujol/ ICO Badalona

Badalona, 08916

Spain

University Hospital Vall D'Hebron

Barcelona, 08035

Spain

Hospital Clínic de Barcelona

Barcelona, 08036

Spain

ICO L'Hospitalet (Instituto Catalán de Oncología)

Barcelona, 08908

Spain

Hospital Universitario de La Princesa

Madrid, 28006

Spain

Hospital Universitario Gregorio Marañón

Madrid, 28009

Spain

Hospital Infanta Leonor

Madrid, 28031

Spain

Hospital Universitario Ramón y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

CIOCC Hospital Universitario HM Sanchinarro

Madrid, 28050

Spain

Universidad de Navarra

Pamplona, 31008

Spain

Hospital Universitario y Politécnico La Fe de la Comunidad Valenciana

Valencia, 46026

Spain

Karolinska Comprehensive Cancer Center

Stockholm,

Sweden

The Royal Marsden

Sutton, Surrey SM2 5PT

United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust,

Bebington, CH63 4JY

United Kingdom

University Hospitals Bristol

Bristol,

United Kingdom

University Hospital of Wales

Cardiff,

United Kingdom

Royal Derby Hospital

Derby, DE22 3NE

United Kingdom

Western General Hospital

Edinburgh, EH4 2XU

United Kingdom

Gartnavel General Hospital

Glasgow, G12 0YN

United Kingdom

Leicester Royal Infirmary

Leicester,

United Kingdom

St Bartholomew's Hospital

London, EC1A 7BE

United Kingdom

Sarah Cannon Research Institute UK

London, W1G 6AD

United Kingdom

NIHR University College London Clinical Research Facility

London, W1T 7HA

United Kingdom

Imperial College

London,

United Kingdom

The Christie Hospital

Manchester,

United Kingdom

Newcastle upon Tyne Hospitals

Newcastle upon Tyne,

United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB

United Kingdom

Cancer and Haematology Centre

Oxford, OX3 7LE

United Kingdom

University Hospital of Southampton

Southampton, SO16 6YD

United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG

United Kingdom