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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| BioGene Life Science | INDUSTRY |
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The Principal Investigator believes that Vitamin E δ-Tocotrienol will slow the progression of pancreatic cancer cells. Therefore, the investigators must determine the safety and tolerability of Vitamin E δ-Tocotrienol in healthy participants before administering to cancer patients. The investigators will do this by giving participants a dose of up to1600 mg twice a day, not to exceed 3200 mg total for 14 consecutive days.
Participants will be accrued in cohorts of three. The decision to dose escalate will be made by the Cohort Review Committee (CRC) based on safety after the last subject in the current cohort has completed the Study Treatment Period. The study will consist of the following procedures:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Dose Escalation | Experimental | Each investigator will be provided with adequate supplies of Vitamin E δ -Tocotrienol, which will be supplied as 100-mg, 200-mg, and 400-mg capsules. Vitamin E δ-Tocotrienol will be administered orally once. The dose administered to each subject will be fixed and based on cohort assignment. Doses will be administered at the clinical site during each protocol-defined visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin E δ-Tocotrienol | Drug | Vitamin E δ-Tocotrienol will be administered orally as a single agent twice daily for 14 consecutive days. Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules. The first cohort will be dosed with δ-tocotrienol at 100 mg twice daily for 14 consecutive days. A minimum of 3 subjects is planned for each dosing cohort with Vitamin E δ-Tocotrienol dose escalation dependent on safety and available PK data from prior cohorts. At the MTD or MAD, 18 subjects will be enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events | The primary objective of this study is to evaluate the safety and tolerability of Vitamin E δ-Tocotrienol and to determine the maximum administered dose (MAD) or maximum tolerated dose (MTD) of Vitamin E δ-Tocotrienol administered twice daily for 14 days. Safety analyses and summary tables will include data collected for all subjects who receive at least one dose of study drug. | 3 Weeks Per Participant |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Vitamin E δ-Tocotrienol | To determine the effects of dose on the plasma pharmacokinetic (PK) of Vitamin E δ-Tocotrienol following multiple dose administration in healthy subjects. | 3 Weeks Per Participant |
| Pharmacodynamic (PD) Markers of Vitamin E δ-Tocotrienol Activity in Peripheral Blood |
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Inclusion Criteria:
Equal to or greater than 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Adequate organ function:
Has the capability of understanding the informed consent document and has signed the informed consent document
Sexually active participants (male and female) must use medically acceptable methods of contraception during the course of the study.
Women of childbearing potential must have a negative pregnancy test at screening.
Able to understand and comply with the requirements of the protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Klapman, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C082097 | tocotrienol, delta |
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Peripheral blood mononuclear cells will be collected at each time point for examination of biomolecular markers not limited to Erk, p-Erk, AKT, p-AKT, p27, Ki-67, and exportin. |
| Day 1, Day 8 Day 14 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |