RECRUITING

Study to Evaluate CCS1477 (inobrodib) in Haematological Malignancies

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2019-08-09
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04068597

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of consent
  2. * ECOG performance status 0-2
  3. * Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)
  4. * Must have previously received standard therapy
  5. * Adequate organ function
  1. * Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
  2. * Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment
  3. * Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
  4. * Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment
  5. * Patients should discontinue statins prior to starting study treatment
  6. * CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
  7. * Any unresolved reversible toxicities from prior therapy \>CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)
  8. * Any evidence of severe or uncontrolled systemic diseases
  9. * Any known uncontrolled inter-current illness
  10. * QTcF prolongation (\> 480 msec)

Contacts and Locations

Study Contact

Tomasz Knurowski, PhD
CONTACT
07882871299
Tomasz.Knurowski@cellcentric.com
Karen Clegg, MD, MFPM
CONTACT
Karen.Clegg@cellcentric.com

Principal Investigator

Tim Somervaille
PRINCIPAL_INVESTIGATOR
The Christie NHS Foundation Trust

Study Locations (Sites)

The Center for Cancer and Blood Disorders (CCBD)
Bethesda, Maryland, 20817
United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
United States

Collaborators and Investigators

Sponsor: CellCentric Ltd.

  • Tim Somervaille, PRINCIPAL_INVESTIGATOR, The Christie NHS Foundation Trust

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-09
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2019-08-09
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Haematological Malignancy
  • Acute Myeloid Leukemia
  • Non Hodgkin Lymphoma
  • Multiple Myeloma
  • Higher-risk Myelodysplastic Syndrome
  • Peripheral T Cell Lymphoma