Tocovid SupraBio* 200mg po bd plus pentoxifylline (PTX) 400mg po bd for 12 months.

Long-term Adverse Effects of Radiotherapy for Pelvic Cancer

Tocovid SupraBio plus pentoxifylline

Matching placebos

The Royal Marsden NHS Foundation Trust

PPALM-Palm Oil and Pentoxifylline Against Late Morbidity

Randomised Double-blind Placebo Controlled Phase II Trial of Tocovid SupraBio in Combination With Pentoxifylline (PTX) in Patients Suffering Long-term Adverse Effects of Radiotherapy for Pelvic Cancer

Tissue samples will be banked until after the final analysis of the trial, when funding will be sought to identify molecular and cellular correlates of therapeutic response in the event of a statistically significant benefit for Tocovid SupraBio/ PTX combination.

Development of novel markers of fibrosis.

Royal Marsden NHS Foundation Trust

Malaysia Palm Oil Board

Vitamin E δ-Tocotrienol will be administered orally as a single agent once. Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules.

Pancreatic Cancer

The first cohort will be dosed with δ-tocotrienol at 200 mg. A minimum of 3 participants is planned for each dosing cohort with Vitamin E δ-Tocotrienol dose escalation dependent on safety from prior cohorts.

Vitamin E δ-Tocotrienol

Moffitt Cancer Center Clinical Trials website

H. Lee Moffitt Cancer Center and Research Institute

Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects

A Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of Vitamin E δ-Tocotrienol Following Single Dose Administration in Healthy Subjects

The primary objective of this study is to evaluate the safety and tolerability of Vitamin E δ-Tocotrienol and to determine the minimally effective dose (MED) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol administered once. Safety will be assessed by standard clinical findings and laboratory tests. Toxicity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)v.4.0. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables.

Pharmacokinetic (PK) markers of Vitamin E δ-Tocotrienol in the plasma, urine, and neoplastic tissue of participants with pancreatic neoplasia. To determine the effects of dose on the plasma pharmacokinetic (PK) of Vitamin E δ-Tocotrienol when orally administered as a single dose in healthy subjects. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables. Dose escalation will be based on safety and available PK data.

Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol in the plasma, urine, and neoplastic tissue of participants with pancreatic neoplasia. To evaluate pharmacodynamic (PD) markers of Vitamin E δ-Tocotrienol activity in peripheral blood. Ninety-five percent confidence intervals may be calculated for selected safety and exploratory variables. Correlative analysis of PD data will be done.

gamma tocotrienol/vėžys

PPALM-Palm Oil and Pentoxifylline Against Late Morbidity

Vitamin E δ-Tocotrienol (VEDT) Single Dose in Healthy Subjects

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