CancerPhase 1NCT00752011
Phase I Study of TAS-106 in Combo With Carboplatin
A Phase 1 study testing TAS-106 and Carboplatin in people with Cancer and Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumors
- What is being tested?
- TAS-106 and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of a solid tumor. Advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy exists
- Objective evidence or disease recurrence or metastatic disease
- Age >/= 18 years old at study entry
- Measurable or evaluable disease
- A score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
- Hemoglobin > 9.0 g/dL; Platelet count >/=100,000/uL; Absolute neutrophil count (ANC) >/=1500/uL
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- Serum creatinine </=1.5 mg/dL; if > 1.5mg/dL, then a calculated creatinine clearance must be >/=60 mL/min
- Total bilirubin </=1.5 mg/dl; ALT </= 2 times the upper limit of normal (ULN) (may be </= 5 times ULN if due to metastatic disease in the liver).
- Fertile men and women, and their partners, must use a medically effective contraception method (spermicide with male or female condoms, cervical sponge, IUD, cervical cap, or diaphragm or oral, implantable, transdermal, or injectable contraceptives) throughout the treatment period and for 30 days after the last dose of study medication. Premenopausal women of reproductive capacity and women less than 12 months after menopause must have a negative pregnancy test documented prior to study entry.
- Signed written informed consent per institutional and federal regulatory requirements.
Who cannot join
- Has known hypersensitivity to carboplatin
- Radiological or clinical evidence of brain involvement or leptomeningeal disease
- Have history of Human Immunodeficiency Virus, hepatitis B, or hepatitis C infection
- >/=grade 2 peripheral neuropathy
- Women who are pregnant or breast feeding.
- Serious illness or medical condition(s) including but not limited to the following: a) Congestive heart failure or uncontrolled angina pectoris. Previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or dysrhythmias. b) Active infection. c) Unstable diabetes mellitus. d) Psychiatric disorder that may interfere with consent and/or protocol compliance
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- Female or male subject of reproductive capacity who is unwilling to use methods appropriate to prevent pregnancy during the course of this study.
- Receiving concurrent chemotherapy, investigational agents radiotherapy, or surgery.
- Received radiation therapy to >30% of bone marrow (e.g., whole of pelvis or half of spine).
- Received any investigational drug within the last 30 days.
- Not fully recovered from any prior surgery (at least 4 weeks recovery period for major surgery), and from any reversible side effects related to the administration of cytotoxic chemotherapy, investigational agents, or radiation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors
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.
Objectives:
Primary Objectives:
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
Secondary objectives:
To assess the antitumor activity of TAS-106 combined with carboplatin
To investigate the relationship between selected biomarkers and efficacy and safety outcomes.
Read the detailed description
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.
Study Visits:
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.
End-of-Study Visit:
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.
- Conditions
- Cancer, Solid Tumors
- Being tested
- TAS-106, Carboplatin
- Keywords
- Cancer, Solid Tumors, Advanced Cancer, Carboplatin, Paraplatin, TAS-106, Antitumor Activity, Biomarkers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-106Drug
Starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle.
CarboplatinDrug
Also called Paraplatin
Starting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle.
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin + TAS-106 | Experimental | 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. Receives: Drug: TAS-106; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: With every 3 week cycle
Secondary outcomes (1)
To review relationship between selected biomarkers and efficacy/safety outcomes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Aung Naing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752011
- Sponsor's protocol ID
- 2007-0623
- Status last verified
- Oct 2012
- First submitted
- 10 Sep 2008
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalating Study Of Tas-106 In Combination With Carboplatin In Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00752011
- Acronym / sponsor ID
- 2007-0623
- Conditions
- Cancer, Solid Tumors
- Keywords
- Cancer, Solid Tumors, Advanced Cancer, Carboplatin, Paraplatin, TAS-106, Antitumor Activity, Biomarkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- Jun 2008
- Primary completion
- Oct 2012 (actual)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Objectives:
Primary Objectives:
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
Secondary objectives:
To assess the antitumor activity of TAS-106 combined with carboplatin
To investigate the relationship between selected biomarkers and efficacy and safety outcomes.
Detailed description
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.
Study Visits:
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.
End-of-Study Visit:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin + TAS-106 | Experimental | Drug: TAS-106, Drug: CarboplatinCarboplatin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed diagnosis of a solid tumor. Advanced or metastatic disease that is refractory to standard therapy or for which no standard therapy exists
- Objective evidence or disease recurrence or metastatic disease
- Age >/= 18 years old at study entry
- Measurable or evaluable disease
- A score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale
Key exclusion criteria (11 listed)
- Has known hypersensitivity to carboplatin
- Radiological or clinical evidence of brain involvement or leptomeningeal disease
- Have history of Human Immunodeficiency Virus, hepatitis B, or hepatitis C infection
- >/=grade 2 peripheral neuropathy
- Women who are pregnant or breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-106Starting dose 2.0 mg/m^2 by vein over 24 hours, Day 1 of 3 Week Cycle. | Drug | Carboplatin + TAS-106 |
| CarboplatinAlso: ParaplatinStarting dose AUC of 4, administered by vein over 60 minutes, Day 1 of 3 Week Cycle. | Drug | Carboplatin + TAS-106 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: With every 3 week cycle
1 secondary outcome
To review relationship between selected biomarkers and efficacy/safety outcomes.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
- U.T. M.D. Anderson Cancer Center websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aung Naing, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAS-106 and Carboplatin in people with Cancer and Solid Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: With every 3 week cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2012.