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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012743-42 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Oxford | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| Cancer Research UK | OTHER |
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The purpose of this study is to determine the highest dose of CXD101 (a novel histone deacetylase inhibitor) that can be safely administered to patients with advanced tumours. The study will also investigate the use of HR23B expression in tumour as a biomarker of response to treatment with CXD101. Patients with solid tumours, lymphoma and myeloma can be considered for this study.
Patients will be treated with CXD101 administered orally starting at 1mg twice a day (ie: 2mg/day). Dose escalation will proceed according to a standard 3+3 phase 1 scheme. Adverse experiences will be evaluated according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. Dose escalation will continue until dose limiting toxicity is encountered in >1/3rd of patients at any dose level. The dose level below this will be determined to be the maximum tolerated dose. Patients will be treated, at the discretion of the Principal Investigator, until disease progression, unacceptable toxicity or the withdrawal of consent. At the maximum tolerated dose a further 20 patients, defined by tumour HR23B expression will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CXD101 | Experimental | Dose escalation study of CXD101 administered orally twice daily for 5 consecutive days in every 21 day cycle. Starting dose 1mg twice daily (2mg/day). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CXD101 | Drug | Capsules, administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose of CXD101 administered twice daily for 5 consecutive days every 21 days | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetic (PK) profile of CXD101 following single and multiple dosing | 18 months | |
| To enable a preliminary assessment of the anti-tumour activity of CXD101 | 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford University Hospitals NHS Trust | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34301221 | Derived | Booth SW, Eyre TA, Whittaker J, Campo L, Wang LM, Soilleux E, Royston D, Rees G, Kesavan M, Hildyard C, Kazmi F, La Thangue N, Kerr D, Middleton MR, Collins GP. A Phase 2a cohort expansion study to assess the safety, tolerability, and preliminary efficacy of CXD101 in patients with advanced solid-organ cancer expressing HR23B or lymphoma. BMC Cancer. 2021 Jul 23;21(1):851. doi: 10.1186/s12885-021-08595-w. |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| To evaluate the tissue expression of the biomarker HR23B |
| 24 months |
| To assess the pharmacodynamic effect of CXD101 | 24 months |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |