Phase I Study of TAS-106 in Combo With Carboplatin
The goal of this clinical research study is to find the highest safe dose of the combination of TAS-106 and carboplatin that can be given to patients with advanced cancer or cancer that has spread.
To determine the maximum tolerated dose (MTD) of the combination of TAS-106 and carboplatin administered by intravenous infusion every 3 weeks.
To perform Pharmacokinetic (PK) analysis of TAS-106 and carboplatin
To assess the antitumor activity of TAS-106 combined with carboplatin
To investigate the relationship between selected biomarkers and efficacy and safety outcomes.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors|
- Maximum tolerated dose (MTD) [ Time Frame: With every 3 week cycle ] [ Designated as safety issue: Yes ]
- To review relationship between selected biomarkers and efficacy/safety outcomes. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Carboplatin + TAS-106
Carboplatin starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle. TAS-106 starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle.
Starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle.Drug: Carboplatin
Starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle.
Other Name: Paraplatin
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The Study Drugs:
TAS-106 and carboplatin are designed to interfere with the growth of cancer cells by stopping cell division, which may cause the cells to die.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of the study drug combination that is based on when you joined this study. Up to 6 dose levels of the study drug combination will be tested. Three (3) participants will be enrolled at each dose level. If no intolerable side effects occur in the first group of 3 people, the next 3 people enrolled in the study will receive the same dose of carboplatin and a higher dose of TAS-106. If this second group has no intolerable side effects, the next 3 people will receive a higher dose of carboplatin while receiving the same dose of TAS-106 as the second group. This will continue until the highest safe dose combination is found.
Study Drug Administration:
A "cycle" in this study is 3 weeks long. On Day 1 of each cycle, you will receive carboplatin by vein over 60 minutes, followed by TAS-106 by vein over 24 hours.
On Day 1 of each cycle (+/- 1 day), you will come to the clinic to have the following procedures performed:
- You will have a complete physical exam, including measurement of vital signs and weight.
- You will have a neurological exam.
- You will be asked about any drugs you have taken recently and any side effects you may have experienced. The study doctor may give you drugs to lessen any possible side effects.
- You will have a performance status evaluation.
- Blood (about 3 teaspoons) and urine will be collected for routine tests.
On Day 1 of Weeks 2 and 3 of each cycle (+/- 3 days), blood (about 3 teaspoons) will be drawn for routine tests. If your blood cell counts (white blood cells, red blood cells, and/or platelets) drop to a low level, you may need to have these routine tests repeated more often than once a week.
At the end of every 2 cycles (+/- 1 week), you will have CT scans, MRI scans, and/or x-rays to check the status of the disease.
You must stay in the Houston area during Cycle 1. During that time, all blood tests and other study tests and procedures must be done at MD Anderson. Starting in Cycle 2, if you prefer, you may have the blood tests at Weeks 2 and 3 of each cycle performed at a medical laboratory that is close to your home. If you need to have the additional blood cell count testing performed as well, those blood tests can also be done close to home. All other study tests and procedures must be done at M. D. Anderson.
Length of Study Participation:
You may continue to stay on the study drugs for as long as you are benefiting. If the cancer gets worse or you experience intolerable side effects, you will be taken off study. If you experience side effects that are severe but not intolerable, however, your doctor may decide that it is necessary to delay your next dose of the study drug combination and/or lower the dose.
When you go off study for any reason, you will have an end-of-study visit with all of the same tests performed as at your other study visits. You will also have an ECG.
This is an investigational study. Carboplatin is FDA approved and commercially available for other uses. TAS-106 is not FDA approved or commercially available. The combination of carboplatin and TAS-106 is not FDA approved or commercially available. At this time, the combination is being used in research only.
Up to 55 patients will take part in this study. All will be enrolled at MD Anderson.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Aung Naing, MD||M.D. Anderson Cancer Center|