1. Age 18 years.
2. Life expectancy of at least 12 weeks.
3. ECOG performance score of 1
4. Histologically or cytologically confirmed malignant tumour with the potential to
benefit from HDAC inhibitor therapy.
5. High HR23B expressing tumour sample on IHC (expansion cohort only).
6. Evaluable disease.
7. The patient is willing and able to comply with the protocol for the duration of the
study, including scheduled follow-up visits and examinations.
8. Patients must have recovered from effects of prior treatments, including surgeries
(persistent grade 1 toxicities are permitted at the discretion of the Chief
9. Female patients with reproductive potential must have a negative urine or serum
pregnancy test within 14 days prior to start of trial. Both women and men must agree
to use a medically acceptable method of contraception throughout the treatment period
and for 16 weeks after discontinuation of treatment. Oral contraception and
parenteral hormonal contraceptives (patches, injectables and implants) that may be
affected by enzyme-inducing drugs should only be used in combination with a barrier
method. All males with partners of childbearing potential or whose partners are
pregnant must use barrier contraception for the duration of dosing and for 16 weeks
10. Able to give written (signed and dated) informed consent.
11. Haematological and biochemical indices within acceptable ranges as detailed in study
1. Pregnant or breast-feeding women or women of childbearing potential unless effective
methods of contraception are used.
2. Other psychological, social or medical condition, physical examination finding or a
laboratory abnormality that the Investigator considers would make the patient a poor
trial candidate or could interfere with protocol compliance or the interpretation of
3. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or
4. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or use
of other investigational agents within 28 days prior to trial entry (or a longer
period depending on the defined characteristics of the agents used). Limited field
radiotherapy to an isolated lesion in bone or soft tissue must be completed 2 weeks
prior to trial entry.
5. Patients must not receive any concurrent anti-cancer therapy, including
investigational agents, while on-study. Patients may continue the use of
bisphosphonates for bone disease or corticosteroids providing the dose is stable
before and during the trial.
6. Major surgery within 4 weeks of starting the study.
7. Co-existing active infection requiring parenteral antibiotics or serious concurrent
illness deemed clinically significant.
8. Patients with known brain metastases, unless these are shown to be stable
(symptomatically and/or radiologically) over a period of 2 months or more.
9. History of refractory nausea and vomiting, chronic GI diseases (eg: inflammatory
bowel disease) or significant bowel resection that would preclude adequate absorption
of oral medication.
10. Patients who are unable to swallow oral medication.
11. Patients with corrected QT interval >450msec.
12. Persistent grade 2 or greater toxicities from any cause.
13. Previous treatment with a HDAC inhibitor.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both