PBI 05204 capsules dosed at 0.2255 mg/kg/day, continuous dosing

Pancreatic Cancer

PBI 05204

Scottsdale Healthcare Hospitals

Florida Hospital Tampa

Vanderbilt University Medical Center

Virginia Cancer Specialists

Virginia Mason Medical Center

Efficacy and Safety Study of PBI-05204 in Patients With Stage IV Metastatic Pancreatic Adenocarcinoma

A Phase II, Single-arm, Open-label, Bayesian Adaptive Efficacy and Safety Study of PBI-05204 in Patients With Stage IV Metastatic Pancreatic Adenocarcinoma

Phoenix Biotechnology, Inc

Anvirzel administered sublingually. A total of five dose cohorts evaluated (6, 12, 24, 36, 48 mg/m2/day; SL divided into 3 doses given every 8 hrs) with 3 patients per cohort. Patients receive the assigned dose (2, 4, 8, 12, or 16 mg/m2) of Anvirzel three times a day throughout each cycle for a total of 4 cycles of chemotherapy. Cycles occur every 21 days. Patients start with an AUC of 6 for Carboplatin and 75mg/m2 for docetaxel, and on subsequent cycles, modifications at the discretion of the treating team. Questionnaire completion regarding physical and mental at baseline, 7 days before chemotherapy, day 1 of chemotherapy, day 1 of cycles 2, 3, and 4, and at end of dosing visit.

Chemotherapeutic Agent Toxicity

Lung Cancer

AUC 6 by vein 7 days after Anvirzel administration in a 21 dayc cycle.

Carboplatin

75 mg/m2 by vein 7 days after Anvirzel administration in a 21 day cycle.

Docetaxel

Starting Cohort Dose: 6 mg/m2 given 3 times a day administered sublingually for a 21 day cycle.
Expansion Cohort Starting Dose: Maximum tolerated dose from

Anvirzel

Questionnaire completion regarding physical and mental at baseline, 7 days before chemotherapy, day 1 of chemotherapy, day 1 of cycles 2, 3, and 4, and at end of dosing visit.

Questionnaires

The University of Texas MD Anderson Cancer Center Official Website

Sublingual Anvirzel in Advance Non-Small Cell Lung Cancer (NSCLC)

A Phase I Study of the Combination of Carboplatin, Docetaxel, and Increasing Doses of Sublingual Anvirzel (Nerium Oleander) in Advance Non-Small Cell Lung Cancer

Pharmacokinetic studies evaluate plasma concentrations over a 24 hour period prior to administration of chemotherapy, using high performance liquid chromatographic and electron ion-spray mass spectrometry

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Nerium Biotechnology

PBI-05204 starting dose = 0.0083 mg/kg/day by mouth (PO) x 3 weeks per cycle.

Solid Tumors

Starting dose = 0.0083 mg/kg/day by mouth (PO) x 3 weeks per cycle

PBI-05204

The University of Texas M.D.Anderson Cancer Center

nerium oleander/neoplasms

Efficacy and Safety Study of PBI-05204 in Patients With Stage IV Metastatic Pancreatic Adenocarcinoma

Sublingual Anvirzel in Advance Non-Small Cell Lung Cancer (NSCLC)

Trial of PBI-05204 in Advanced Cancer Patients

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