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A Phase 1/2A Dose Escalation Study of 2-hydroxyoleic Acid (2-OHOA; Minerval®) in Adult Patients With Advanced Solid Tumours Including Malignant Glioma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Glioma, Other Solid Tumours

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Trial Information

A Phase 1/2A Dose Escalation Study of 2-hydroxyoleic Acid (2-OHOA; Minerval®) in Adult Patients With Advanced Solid Tumours Including Malignant Glioma

This is an open label, non-randomized study in patients with advanced solid tumours
including malignant glioma. The study will be performed in two phases - a dose escalation
phase following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a safe
dose of 2-OHOA followed by two expanded safety cohorts (approximately 10 of whom have
malignant glioma and approximately 10 of whom have other advanced solid tumours that are
suitable for biopsy) treated at the maximum tolerated dose (MTD). If the MTD is well
tolerated in the expanded safety cohorts, that dose becomes the recommended phase 2 dose
(RP2D). During each dose cohort, at least one week must elapse between the first and
subsequent patients receiving treatment with 2-OHOA. Up to five dose cohorts are

Patients may receive palliative localized radiotherapy, if needed (however, this lesion
cannot be a target lesion for evaluation of the treatment response).

Safety, pharmacokinetics (PK), pharmacodynamics and efficacy will be evaluated during the
study at pre-defined timepoints

Inclusion Criteria

Inclusion Criteria

- Males or females providing written, informed consent

- Histologically- or cytologically-confirmed advanced solid malignancy that is
refractory to standard-of-care treatment, or for which there is no standard therapy.
If this is glioma:Grade III / Grade IV malignant glioma recurring or progressing
after first or second line standard-of-care treatment and true progressive disease,
confirmed according to the RANO criteria 4.

- Life-expectancy of at least 12 weeks

- Eastern cooperative oncology group (ECOG) performance status of 0-2

- Safety laboratory tests and ECGs within specified limits.

- Using adequate contraception, where applicable

- Presence of lesions suitable for biopsy (mandatory for non-glioma patients enrolled
in the expanded safety cohort and highly desirable for non-glioma patients enrolled
in the dose escalation phase)

Exclusion Criteria

- Anti cancer therapy within 4 weeks (6 weeks for mitomycin and nitrosureas and 2 weeks
for palliative radiotherapy)

- NCI Common terminology criteria for adverse events (CTCAE) >Grade 1 toxicities from
prior chemotherapy or radiotherapy that could impact on safety outcome assessment

- Recent >Grade 1 intracranial or intratumoural haemorrhage either by CT or MRI scan.
Patients with resolving haemorrhage changes, punctuate haemorrhage or haemosiderin
may enter the study

- Significant or uncontrolled cardiovascular disease, unstable angina or myocardial
infarction within the preceding 6 months

- Known impairment of GI function that could alter the absorption of study drug

- History of uncontrolled hyperlipidemia and/or the need for concurrent lipid lowering

- Concurrent severe and/or uncontrolled other medical disease that could compromise
participation in the study

- Taking warfarin, phenytoin or sulphonylureas (glibenclamide, glimepiride, glipizide,
glyburide or nateglanide)

- Pregnant or breast feeding Other protocol specific criteria may apply

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of patients with adverse events

Outcome Description:

All adverse events will be recorded including clinically significant physical examinations and vital signs, laboratory safety tests and 12-lead electrocardiograms

Outcome Time Frame:

From the first dose of study drug until 30 days after the last dose of study drug

Safety Issue:


Principal Investigator

Professor Johann de Bono, MB ChB FRCP MSc PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Institute of Cancer Research, 15 Cotswold Road, Belmont, Sutton, Surrey, United Kingdom SM2 5NG


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2013

Completion Date:

November 2014

Related Keywords:

  • Glioma
  • Other Solid Tumours
  • Glioma
  • Solid Tumours
  • Minerval
  • Glioma
  • Neoplasms