NCT02223052

Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

Completed Phase 1 Last updated 12 May 2020

What this trial tests

Phase 1 trial testing CC-486 in Hematological Neoplasms in 89 participants. Completed in 18 December 2018.

Timeline

27 October 2014

Primary endpoint
11 June 2018

18 December 2018

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	89
Start date	27 October 2014
Primary completion	11 June 2018
Estimated completion	18 December 2018
Sites	10 locations across United States

Drugs / interventions tested

• CC-486
• Vidaza (azacitidine) — full drug profile →

Conditions studied

• Hematological Neoplasms — all drugs for Hematological Neoplasms →
• Non-Hodgkin's Lymphoma — all drugs for Non-Hodgkin's Lymphoma →
• Hodgkin's Lymphoma — all drugs for Hodgkin's Lymphoma →
• Lymphoma — all drugs for Lymphoma →

Sponsor

Celgene — full company profile →

Who can join

18 and older, any sex, with Hematological Neoplasms or Non-Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases:

Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension

This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate in this study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
2. IDH1 and IDH2 mutations as novel therapeutic targets: current perspectives.
   Mondesir J, Willekens C, Touat M, de Botton S. · · 2016 · cited 153× · PMID 27621679 · DOI 10.2147/jbm.s70716
3. Aberrant DNA methylation in melanoma: biomarker and therapeutic opportunities.
   Micevic G, Theodosakis N, Bosenberg M. · · 2017 · cited 131× · PMID 28396701 · DOI 10.1186/s13148-017-0332-8
4. Epigenetic Targeting of Glioblastoma.
   Romani M, Pistillo MP, Banelli B. · · 2018 · cited 82× · PMID 30386738 · DOI 10.3389/fonc.2018.00448
5. From signalling pathways to targeted therapies: unravelling glioblastoma's secrets and harnessing two decades of progress.
   Dewdney B, Jenkins MR, Best SA, Freytag S, et al · · 2023 · cited 60× · PMID 37857607 · DOI 10.1038/s41392-023-01637-8
6. DNA Methylation as a Therapeutic Target for Bladder Cancer.
   Nunes SP, Henrique R, Jerónimo C, Paramio JM. · · 2020 · cited 59× · PMID 32784599 · DOI 10.3390/cells9081850
7. Distinct gene expression profiles between primary breast cancers and brain metastases from pair-matched samples.
   Iwamoto T, Niikura N, Ogiya R, Yasojima H, et al · · 2019 · cited 43× · PMID 31527824 · DOI 10.1038/s41598-019-50099-y
8. Emerging Epigenetic-Based Nanotechnology for Cancer Therapy: Modulating the Tumor Microenvironment.
   Zhang J, Huang L, Ge G, Hu K. · · 2023 · cited 32× · PMID 36599655 · DOI 10.1002/advs.202206169