A Phase 1 interventional study of PBI-05204 in Solid Tumors, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
The goal of this clinical research study is to find the highest safe dose of PBI-05204 that can be given to patients with advanced solid tumors. The study will also look at how PBI-05204 is processed by the body, how it leaves the body, how it affects the body, and if it is affecting certain proteins in the cancer cells.
The Study Drug PBI-05204, made from the oleander plant, is designed to prevent the growth of cancer cells by affecting proteins that lead to cell death.
Screening Tests
Before you can begin receiving the study drug, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests will be performed:
Study Drug Dose Level:
If you are found to be eligible to take part in this study, the amount of PBI-05204 that you take will be based on how many participants have been enrolled before you, and on the safety information that is available. There may be up to 6 participants enrolled in each group. The first group of participants enrolled on this study will receive PBI-05204 at the lowest dose level. If no intolerable side effects are experienced, the next group of participants will take a higher dose level. This process will continue until researchers find the highest dose of PBI-05204 that can be given without intolerable side effects occurring.
Study Drug Administration:
Depending on which group you are enrolled in, you will take the PBI-05204 capsules by mouth every day at the same time or twice a day (every 12 hours). Your Doctor will tell you which schedule you are on. You will take the drug on Days 1-21. On Days 22-28 you will take no study drug. Each 28 days is called a "study cycle".
Study Visits:
At the Predose Visit, 1-7 days before Day 1 of Cycle 1 you will have the following tests and procedures performed:
On Day 1 Cycle 1 you will have the following tests and procedures performed:
On Day 2 of Cycle 1 you will have the following:
On Day 7 of Cycle 1 you will have the following:
On Day 8 of Cycle 1 you will have the following tests and procedures performed:
On Day 15 of Cycle 1 you will have the following tests and procedures performed:
On Day 21 of Cycle 1 you will have the following tests and procedures performed:
During the last week of Cycle 2, the following tests and procedures will be performed:
On Day 1 of Cycles 3 and beyond you will have a physical exam, including measurement of your vital signs.
At the end of every 2 cycles beginning with Cycle 4 (Cycles 4, 6, 8, and so on) blood (about 3-4 teaspoons) and urine will be collected for routine tests. You will have a CT or MRI.
If you are enrolled in the expansion group, blood (about 2 teaspoons each time) will be collected for PK testing before you take the daily dose of the study drug and then 1, 2, 4, 6, 8 and 24 hours later on Day 1 of Cycle 1. On Days 8, 15 and 21 of Cycle 1, blood (about 2 teaspoons each time) will also be collected for PK testing before you take the daily dose of the study drug and then 1, 2, 4, 6 and 8 hours later.
If you are enrolled in the expansion group, you will also have two mandatory tumor biopsies collected within 1- 7 days before you take your daily dose of the study drug and once during Days 15-21 of Cycle 1. To collect the biopsy, your doctor will insert a needle into the tumor and withdraw a small piece of the tumor. The tumor tissue will be studied to look at special "markers" in the tumor that may help researchers predict who may benefit from the study drug.
Length of Study:
You will remain on study until the disease gets worse, you decide to come off study, your doctor decides it is in your best interest to come off the study, you have intolerable side effects, or the sponsor closes the study.
If you decided to leave the study early you must tell the study doctor in writing and return any unused study drug. You must complete the end-of-study visit.
End-of-Study Visit:
Once you are off-study, you will have an end-of-study visit within 30 days after the last dose of PBI-05204. At this visit, the following tests and procedures will be performed:
Long-Term Follow-up:
After you complete the end-of-study visit, your study doctor will continue to contact you or your family doctor for a minimum of 30 days. You may be contacted by a phone call (less than 5 minutes), and you will be asked about your general health.
This is an investigational study. PBI-05204 is not FDA approved or commercially available. At this time, PBI-05204 is only being used in research. Up to 52 patients will take part in this study. All will be enrolled at M. D. Anderson.
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PBI-05204 starting dose = 0.0083 mg/kg/day by mouth (PO) x 3 weeks per cycle.
Drug: PBI-05204
Starting dose = 0.0083 mg/kg/day by mouth (PO) x 3 weeks per cycle
Maximum Tolerated Dose (MTD)
Time frame: Continuous assessment of safety throughout entire study period and determination of dose-limiting toxicities during and at the end of 28 Day Cycle(s).
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center