Solid TumorsPhase 1NCT00495872
Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor
A Phase 1 study testing Dasatinib, Erlotinib and Lapatinib in people with 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 tolerable dose of valproic acid in combination with either dasatinib, erlotinib hydrochloride, lapatinib, lenalidomide, sorafenib, or SU011248 (sunitinib malate) that can be given to patients with advanced cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Dasatinib, Erlotinib and Lapatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have advanced solid tumor: they have either a disease where there is no established standard of care therapy or have failed one or more prior therapy. (for all treatment arms)
- Patients must have ECOG performance status < or = 2 (0-2). Patients </=10 years modified Lansky scale >/= 60. Patients >10 to 18 years Karnovsky scale >/= 60.(for all treatment arms)
- Patients must have normal organ and marrow function as defined below: Platelets > 50,000/uL; Creatinine clearance > 20mL/min (for all treatment arms); Total bilirubin < 5 mg/dL (except for Lapatinib arm); ALT </= 6X ULN for Lapatinib arm only;
- (cont. from above) Liver function criteria and dosing based on each individual drug: Valproic acid - if ALT >/= 6X ULN or T. Bili >/= 3, then dose should be decreased by 50%; Sorafenib - If Child Pugh class A or B, no dose adjustment; if Child Pugh class C, decrease dose by 50% (400 mg po daily max); Sunitinib - If ALT >/= 6X ULN or T. Bili >/= 3 , decrease dose by 25% (37.5 mg po daily max);
- (cont. from above) Erlotinib - If ALT > 6X ULN or T. Bili >/= 3 , decrease dose by 25% (100 mg po daily max); Lapatinib - If ALT > 3X ULN or T. Bili > 2X ULN, decrease dose by 60% (500-750 mg po daily max); Dasatinib - No dose adjustment needed; Lenalidomide - No dose adjustment needed.
- Patients or legal representative must be able to understand and be willing to sign an IRB-approved written informed consent document. (for all treatment arms)
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 30 days after the last dose. (for all treatment arms)
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, symptomatic cardiac arrhythmia, active bleeding, active thrombosis, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of allergic reactions to the study drugs or their analogs.
- Failure to recover from any prior surgery within 4 weeks of study entry.
- Any treatment specific for tumor control within 3 weeks of study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycin C), or within 4 half-lives for target agents with half lives and pharmacodynamic effects lasting less than 5 days (that include but are not limited to erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents); or failure to recover from the toxic effect of any therapy prior to study entry.
- Study agents cannot be obtained for any reason since this study does not provide free agents.
- Any prior history of hypertensive crisis or hypertensive encephalopathy.
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- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) and symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study.
- Minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment; and serious, non-healing wound, ulcer, or bone fracture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Arm Complete Phase 1 Trial of Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor
The goal of this clinical research study is to find the highest tolerable dose of valproic acid in combination with either dasatinib, erlotinib hydrochloride, lapatinib, lenalidomide, sorafenib, or SU011248 (sunitinib malate) that can be given to patients with advanced cancer. The safety of each combination of the study drugs will be studied as well.
Read the detailed description
The Study Drugs:
Valproic acid is designed for use as an anti-seizure medication. It is thought to also have anticancer activity by activating ("turning on") tumor-fighting genes, which may cause cancer cell death.
Dasatinib is designed to change the function of genes. By changing the function of these genes, it may prevent cancer from growing and spreading.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.
Lapatinib is designed to block the activity of certain molecules. These molecules play a part in the growth of cancer cells and are particularly important for the growth of inflammatory breast cancer tumors.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.
Sorafenib is designed to block the function of a cancer protein as well as tumor blood-vessel forming proteins.
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Study Administration:
If you are found to be eligible to take part in this study, the study doctor will decide which drug you will receive with valproic acid, based upon your particular disease. You will then begin taking valproic acid plus either dasatinib, erlotinib hydrochloride, lapatinib, lenalidomide, sorafenib, or sunitinib malate. One (1) cycle is either 21 or 28 days long, depending on which study drug combination you receive.
You will take valproic acid by mouth once or twice a day for 7 days in a row. You will then have a 7-day "rest" period from taking this drug.
You will also take either sorafenib or sunitinib malate by mouth once or twice a day continuously for 21 days, or dasatinib, erlotinib hydrochloride, lapatinib, or lenalidomide by mouth once or twice a day continuously for 28 days.
Depending on what stage of the study you are in, you will take the study drugs either once or twice a day.
Study Visits:
You will have the below tests/procedures at designated study visits.
Before each cycle (within 7 days of after your last dose)
- You will be have a complete physical exam.
- Your performance status will be recorded.
- You will be asked about any side effects you may be experiencing.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test. To take part in this study, you must not be pregnant.
After the end of Cycles 2, 4 and 6, you will have a chest x-ray and either a CT scan, MRI scan, or PET scan to check the status of the cancer. You will then have a chest x-ray and either a CT scan, MRI scan, or PET scan after the end of every 3 cycles (Cycle 9, 12, 15, and so on) to check the status of the cancer.
Length of Study:
You will continue to take your study drug combination on this study, as long as the disease does not get worse and you do not experience any intolerable side effects.
End-of-Study Visit:
Once you have stopped taking your study drug combination, you will come back for an end-of-study visit to have the following tests/procedures performed:
- You will have a complete physical exam.
- Your performance status will be recorded.
- Blood may be drawn (about 1 tablespoon) for routine tests
- You may have a CT scan, an MRI scan, or PET to check the status of the cancer, depending on what the study doctor thinks is necessary.
Follow-Up:
The status of the disease will be followed-up for as long as possible after you complete this study. Once every 8 weeks, you will either be contacted by phone and asked how you are feeling (which should take about 5-10 minutes), or you will be asked to come to the clinic for a routine visit. You will have a CT or MRI scan once every 12 weeks (or until another anticancer therapy has been started) to check the status of the cancer.
This is an investigational study. Each of the study drugs is FDA approved and commercially available. The combination of valproic acid plus one of the other study drugs is investigational in this study.
Valproic acid is FDA approved for the treatment of simple and complex absence seizure, complex partial epileptic seizure, acute mania, and migraine prophylaxis.
Dasatinib is FDA approved for the treatment of acute lymphoid leukemia (ALL) and chronic myeloid leukemia (CML).
Erlotinib hydrochloride is FDA approved for the treatment of carcinoma of the pancreas and non-small-cell lung cancer.
Lapatinib is FDA approved for the treatment of breast cancer (inflammatory, relapsed, or refractory) and metastatic breast cancer (HER2 overexpression).
Lenalidomide is FDA approved for the treatment of multiple myeloma and myelodysplastic syndrome.
Sorafenib is FDA approved for the treatment of renal cell carcinoma. Sunitinib malate is FDA approved for the treatment of gastrointestinal stromal tumors and renal cell carcinoma.
Up to 327 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Solid Tumors
- Being tested
- Dasatinib, Erlotinib, Lapatinib, Lenalidomide, Sorafenib
- Keywords
- Solid Tumors, Advanced Cancer, Dasatinib, Erlotinib, Lapatinib, Lenalidomide, Sorafenib, Erlotinib Hydrochloride, Sunitinib Malate, Sunitinib, Valproic Acid, SU011248
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called Sprycel®, BMS-354825
50 mg by mouth (PO) Twice Daily for 28 Days Every 28 Days
ErlotinibDrug
Also called Erlotinib Hydrochloride, OSI-774, Tarceva
100 mg PO Daily for 28 Days Every 28 Days
LapatinibDrug
Also called GW572016
1000 mg PO Daily for 28 Days Every 28 Days
LenalidomideDrug
Also called CC-5013, Revlimid™
15 mg PO Daily for 28 Days Every 28 Days
SorafenibDrug
Also called BAY 43-9006
400 mg PO Daily for 21 Days Every 28 Days
SunitinibDrug
Also called Sunitinib Malate, SU011248
25 mg PO Daily for 21 Days Every 28 Days
Valproic AcidDrug
Also called Depakene
40 mg/kg PO Daily for 7 Days, then 7 Days Off
| Study group | Role | What they receive |
|---|---|---|
| VN | Experimental | Valproic Acid + Sorafenib Receives: Drug: Sorafenib; Drug: Valproic Acid |
| VS | Experimental | Valproic Acid + Sunitinib Receives: Drug: Sunitinib; Drug: Valproic Acid |
| VD | Experimental | Valproic Acid + Dasatinib Receives: Drug: Dasatinib; Drug: Valproic Acid |
| VT | Experimental | Valproic Acid + Erlotinib Receives: Drug: Erlotinib; Drug: Valproic Acid |
| VL | Experimental | Valproic Acid + Lapatinib Receives: Drug: Lapatinib; Drug: Valproic Acid |
| VR | Experimental | Valproic Acid + Lenalidomide Receives: Drug: Lenalidomide; Drug: Valproic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities
Measured: At Day 28 (1 Cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aung Naing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495872
- Sponsor's protocol ID
- 2007-0170
- Status last verified
- Oct 2012
- First submitted
- 2 Jul 2007
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kurzrock R, Atkins J, Wheler J, Fu S, Naing A, Busaidy N, Hong D, Sherman S. Tumor marker and measurement fluctuations may not reflect treatment efficacy in patients with medullary thyroid carcinoma on long-term RET inhibitor therapy. Ann Oncol. 2013 Sep;24(9):2256-61. doi: 10.1093/annonc/mdt177. Epub 2013 May 14.
PubMed 23676418
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
- A Multi-Arm Complete Phase 1 Trial of Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT00495872
- Acronym / sponsor ID
- 2007-0170
- Conditions
- Solid Tumors
- Keywords
- Solid Tumors, Advanced Cancer, Dasatinib, Erlotinib, Lapatinib, Lenalidomide, Sorafenib, Erlotinib Hydrochloride
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Oct 2012 (actual)
- First posted
- 3 Jul 2007 (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 tolerable dose of valproic acid in combination with either dasatinib, erlotinib hydrochloride, lapatinib, lenalidomide, sorafenib, or SU011248 (sunitinib malate) that can be given to patients with advanced cancer. The safety of each combination of the study drugs will be studied as well.
Detailed description
The Study Drugs:
Valproic acid is designed for use as an anti-seizure medication. It is thought to also have anticancer activity by activating ("turning on") tumor-fighting genes, which may cause cancer cell death.
Dasatinib is designed to change the function of genes. By changing the function of these genes, it may prevent cancer from growing and spreading.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.
Lapatinib is designed to block the activity of certain molecules. These molecules play a part in the growth of cancer cells and are particularly important for the growth of inflammatory breast cancer tumors.
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.
Sorafenib is designed to block the function of a cancer protein as well as tumor blood-vessel forming proteins.
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Study Administration:
If you are found to be eligible to take part in this study, the study doctor will decide which drug you will receive with valproic acid, based upon your particular disease. You will then begin taking valproic acid plus either dasatinib, erlotinib hydrochloride, lapatinib, lenalidomide, sorafenib, or sunitinib malate. One (1) cycle is either 21 or 28 days long, depending on which study drug combination you receive.
You will take valproic acid by mouth once or twice a day for 7 days in a row. You will then have a 7-day "rest" period from taking this drug.
You will also take either sorafenib or sunitinib malate by mouth once or twice a day continuously for 21 days, or dasatinib, erlotinib hydrochloride, lapatinib, or lenalidomide by mouth once or twice a day continuously for 28 days.
Depending on what stage of the study you are in, you will take the study drugs either once or twice a day.
Study Visits:
You will have the below tests/procedures at designated study visits.
Before each cycle (within 7 days of after your last dose)
- You will be have a complete physical exam.
- Your performance status will be recorded.
- You will be asked about any side effects you may be experiencing.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test. To take part in this study, you must not be pregnant.
After the end of Cycles 2, 4 and 6, you will have a chest x-ray and either a CT scan, MRI scan, or PET scan to check the status of the cancer. You will then have a chest x-ray and either a CT scan, MRI scan, or PET scan after the end of every 3 cycles (Cycle 9, 12, 15, and so on) to check the status of the cancer.
Length of Study:
You will continue to take your study drug combination on this study, as long as the disease does not get worse and you do not experience any intolerable side effects.
End-of-Study Visit:
Once you have stopped taking your study drug combination, you will come back for an end-of-study visit to have the following tests/procedures performed:
- You will have a complete physical exam.
- Your performance status will be recorded.
- Blood may be drawn (about 1 tablespoon) for routine tests
- You may have a CT scan, an MRI scan, or PET to check the status of the cancer, depending on what the study doctor thinks is necessary.
Follow-Up:
The status of the disease will be followed-up for as long as possible after you complete this study. Once every 8 weeks, you will either be contacted by phone and asked how you are feeling (which should take about 5-10 minutes), or you will be asked to come to the clinic for a routine visit. You will have a CT or MRI scan once every 12 weeks (or until another anticancer therapy has been started) to check the status of the cancer.
This is an investigational study. Each of the study drugs is FDA approved and commercially available. The combination of valproic acid plus one of the other study drugs is investigational in this study.
Valproic acid is FDA approved for the treatment of simple and complex absence seizure, complex partial epileptic seizure, acute mania, and migraine prophylaxis.
Dasatinib is FDA approved for the treatment of acute lymphoid leukemia (ALL) and chronic myeloid leukemia (CML).
Erlotinib hydrochloride is FDA approved for the treatment of carcinoma of the pancreas and non-small-cell lung cancer.
Lapatinib is FDA approved for the treatment of breast cancer (inflammatory, relapsed, or refractory) and metastatic breast cancer (HER2 overexpression).
Lenalidomide is FDA approved for the treatment of multiple myeloma and myelodysplastic syndrome.
Sorafenib is FDA approved for the treatment of renal cell carcinoma. Sunitinib malate is FDA approved for the treatment of gastrointestinal stromal tumors and renal cell carcinoma.
Up to 327 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| VN | Experimental | Drug: Sorafenib, Drug: Valproic AcidValproic Acid + Sorafenib |
| VS | Experimental | Drug: Sunitinib, Drug: Valproic AcidValproic Acid + Sunitinib |
| VD | Experimental | Drug: Dasatinib, Drug: Valproic AcidValproic Acid + Dasatinib |
| VT | Experimental | Drug: Erlotinib, Drug: Valproic AcidValproic Acid + Erlotinib |
| VL | Experimental | Drug: Lapatinib, Drug: Valproic AcidValproic Acid + Lapatinib |
| VR | Experimental | Drug: Lenalidomide, Drug: Valproic AcidValproic Acid + Lenalidomide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have advanced solid tumor: they have either a disease where there is no established standard of care therapy or have failed one or more prior therapy. (for all treatment arms)
- Patients must have ECOG performance status < or = 2 (0-2). Patients </=10 years modified Lansky scale >/= 60. Patients >10 to 18 years Karnovsky scale >/= 60.(for all treatment arms)
- Patients must have normal organ and marrow function as defined below: Platelets > 50,000/uL; Creatinine clearance > 20mL/min (for all treatment arms); Total bilirubin < 5 mg/dL (except for Lapatinib arm); ALT </= 6X ULN for Lapatinib arm only;
- (cont. from above) Liver function criteria and dosing based on each individual drug: Valproic acid - if ALT >/= 6X ULN or T. Bili >/= 3, then dose should be decreased by 50%; Sorafenib - If Child Pugh class A or B, no dose adjustment; if Child Pugh class C, decrease dose by 50% (400 mg po daily max); Sunitinib - If ALT >/= 6X ULN or T. Bili >/= 3 , decrease dose by 25% (37.5 mg po daily max);
- (cont. from above) Erlotinib - If ALT > 6X ULN or T. Bili >/= 3 , decrease dose by 25% (100 mg po daily max); Lapatinib - If ALT > 3X ULN or T. Bili > 2X ULN, decrease dose by 60% (500-750 mg po daily max); Dasatinib - No dose adjustment needed; Lenalidomide - No dose adjustment needed.
Key exclusion criteria (11 listed)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, symptomatic cardiac arrhythmia, active bleeding, active thrombosis, or psychiatric illness/social situations that would limit compliance with study requirements.
- History of allergic reactions to the study drugs or their analogs.
- Failure to recover from any prior surgery within 4 weeks of study entry.
- Any treatment specific for tumor control within 3 weeks of study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycin C), or within 4 half-lives for target agents with half lives and pharmacodynamic effects lasting less than 5 days (that include but are not limited to erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents); or failure to recover from the toxic effect of any therapy prior to study entry.
- Study agents cannot be obtained for any reason since this study does not provide free agents.
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 |
|---|---|---|
| DasatinibAlso: Sprycel®, BMS-35482550 mg by mouth (PO) Twice Daily for 28 Days Every 28 Days | Drug | VD |
| ErlotinibAlso: Erlotinib Hydrochloride, OSI-774, Tarceva100 mg PO Daily for 28 Days Every 28 Days | Drug | VT |
| LapatinibAlso: GW5720161000 mg PO Daily for 28 Days Every 28 Days | Drug | VL |
| LenalidomideAlso: CC-5013, Revlimid™15 mg PO Daily for 28 Days Every 28 Days | Drug | VR |
| SorafenibAlso: BAY 43-9006400 mg PO Daily for 21 Days Every 28 Days | Drug | VN |
| SunitinibAlso: Sunitinib Malate, SU01124825 mg PO Daily for 21 Days Every 28 Days | Drug | VS |
| Valproic AcidAlso: Depakene40 mg/kg PO Daily for 7 Days, then 7 Days Off | Drug | VD, VL, VN, VR, VS, VT |
Primary outcome
Maximum Tolerated Dose (MTD) as Determined by the Number of Participants With Dose Limiting Toxicities
Time frame: At Day 28 (1 Cycle)
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.
- Derived from this study: PubMed 23676418Kurzrock R, Atkins J, Wheler J, Fu S, Naing A, Busaidy N, Hong D, Sherman S. Tumor marker and measurement fluctuations may not reflect treatment efficacy in patients with medullary thyroid carcinoma on long-term RET inhibitor therapy. Ann Oncol. 2013 Sep;24(9):2256-61. doi: 10.1093/annonc/mdt177. Epub 2013 May 14.
- MD 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 Dasatinib, Erlotinib and Lapatinib in people with 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 7 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) as Determined by the Number of Participants With Dose Limiting Toxicities (time frame: At Day 28 (1 Cycle)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00495872, which also lists 1 linked publication.
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.