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Recruiting NCT04068597

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

Phase I / Phase II Interventional Haematological Malignancy Acute Myeloid Leukemia Non Hodgkin Lymphoma Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CCS1477, Pomalidomide, Dexamethasone, Azacitidine.
Who it may be relevant to
Registry conditions: Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Spain, Sweden, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.

Overview

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.

Interventions

  • Drug CCS1477
    Oral capsule
  • Drug Pomalidomide
    oral capsule
  • Drug Dexamethasone
    oral tablet
  • Drug Azacitidine
    Powder suspension for Injection
  • Drug Venetoclax
    Oral tablet
  • Drug Bortezomib
    Powder for solution for injection
  • Drug Ixazomib
    Oral capsule
  • Drug Elranatamab
    Solution for injection
  • Drug Teclistamab
    Solution for injection
  • Drug Lenalidomide
    Oral capsule

Primary outcome measures

  • Incidence of treatment-related adverse events [Time frame: Up to 12 months]
  • Incidence of laboratory abnormalities [Time frame: Up to 12 months]
Secondary outcome measures (4)
  • Response rate [Time frame: Up to 12 months]
  • Duration of Response [Time frame: Up to 12 months]
  • AUC of CCS1477 [Time frame: 35 days]
  • Cmax of CCS1477 [Time frame: 35 days]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 18 centers
  • The Royal Marsden — Sutton
  • The Clatterbridge Cancer Centre NHS Foundation Trust, — Bebington
  • University Hospitals Bristol — Bristol
  • University Hospital of Wales — Cardiff
  • Royal Derby Hospital — Derby
  • Western General Hospital — Edinburgh
  • Gartnavel General Hospital — Glasgow
  • Leicester Royal Infirmary — Leicester
  • … and 10 more centers
Spain · 12 centers
  • Hospital Germans Trias i Pujol/ ICO Badalona — Badalona
  • University Hospital Vall D'Hebron — Barcelona
  • Hospital Clínic de Barcelona — Barcelona
  • ICO L'Hospitalet (Instituto Catalán de Oncología) — Barcelona
  • Hospital Universitario de La Princesa — Madrid
  • Hospital Universitario Gregorio Marañón — Madrid
  • Hospital Infanta Leonor — Madrid
  • Hospital Universitario Ramón y Cajal — Madrid
  • … and 4 more centers
United States · 6 centers
  • Emory Winship Cancer Institute — Atlanta
  • Community Health Network — Indianapolis
  • The Center for Cancer and Blood Disorders (CCBD) — Bethesda
  • Nebraska Cancer Specialists — Omaha
  • University of Nebraska Medical Center — Omaha
  • Penn Medicine - Abramson Cancer Center Perelman — Philadelphia
France · 2 centers
  • Institute Bergonie — Bordeaux
  • Gustave Roussy — Villejuif
Sweden · 1 center
  • Karolinska Comprehensive Cancer Center — Stockholm

Identifiers

NCT: NCT04068597 · CCS1477-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗