Advanced CancersPhase 1NCT01430572
Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients
A Phase 1 study testing Pazopanib and Everolimus in people with Advanced Cancers 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 tolerable dose of the combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients with advanced cancer. The safety of these drugs will also be studied. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Advanced Cancers, Solid Tumors
- What is being tested?
- Pazopanib and Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2011to 12 May 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
- Patients with advanced or metastatic solid tumors that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
- Patients must have been off previous chemotherapy or radiotherapy for two weeks prior to start of treatment. For biologic/targeted therapies, patients must be >/= five half-lives or >/= 2 weeks from the last treatment dose, whichever comes first. Patients may have received palliative localized radiation immediately before (or during) treatment provided radiation is not delivered to the single target lesion available.
- ECOG performance status </= 2.
- Abnormal organ function is permitted. However, patients must meet the following criteria: neutrophil count >/= 1.5 x 10*9/L; platelets >/= 100 x 10*9/L; creatinine </= 1.5 X upper limit of normal (ULN); T. bilirubin </= 1.5 X ULN; AST(SGOT) and/or ALT(SGPT) </= 2.5 X ULN, UPC < 1.
- Women of child-bearing potential MUST have a negative serum or urine HCG test within 14 days of first dose. Sexually active patients must agree to use contraception for the duration of study participation: women, 2 weeks before the first treatment dose and for 28 days after the last dose; and men, from the first treatment dose and for 28 days after the last dose of treatment. For the purpose of this protocol women of child-bearing potential are defined as: a female able to have children that has not been surgically sterilized or that has not been without menses for 12 consecutive months.
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- Patients must be >/=16 years of age.
- Fresh blood samples must be provided for all subjects for biomarker analysis before treatment with investigational product.
- Patients must have evaluable disease by RECIST criteria.
- For the dose expansion cohort patients will have to have any kind of genomic alteration in either PI3K and/or PTEN of their tumor.
Who cannot join
- Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anti-convulsants in prior 2 weeks.
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:Active peptic ulcer disease; Known intraluminal metastatic lesion/s with risk of bleeding; Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn's disease),or other gastrointestinal conditions with increased risk of perforation; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior beginning study treatment.
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to; Malabsorption syndrome; Major resection of the stomach or small bowel
- Corrected QT (QTc) > 480 msecs.
- History of any one or more of the following cardiovascular conditions within the past 6 months:Cerebrovascular accident, Myocardial infarction, Unstable angina , Cardiac angioplasty or stenting, Coronary artery bypass graft surgery, Class III or IV heart failure, as defined by the New York Heart Association (NYHA), Untreated pulmonary embolism (PE) or deep venous thrombosis (DVT). Note: subjects with recent PE or DVT who have been therapeutically coagulated for at least 6 weeks are eligible.
- Uncontrolled systemic vascular hypertension (systolic blood pressure >/= 140 mmHg, diastolic blood pressure >/= 90 mmHg). Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals. At least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement. These three values should be averaged to obtain the mean diastolic BP and mean systolic BP. The mean SBP/DBP ration must be < 140/90.
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- Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
- Evidence of active bleeding or bleeding diathesis.
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage. Note: Lesions infiltrating major pulmonary vessels (contiguous tumor and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions). Large protruding endobronchial lesions in the main or lobar bronchi are excluded; however, endobronchial lesions in the segmented bronchi are allowed. Lesions extensively infiltrating the main or lobar bronchi are excluded; however, minor infiltrations in the wall of the bronchi are allowed.
- Recent hemoptysis (>/= ½ teaspoon of red blood within 8 weeks before first dose of study drug).
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
- Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment.
- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
- Prior malignancy Note: Subjects who have had another malignancy and have been disease-free for 2 years, and/or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Combination of Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients With Advanced Solid Tumors Refractory to Standard Therapy
The goal of this clinical research study is to find the highest tolerable dose of the combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients with advanced cancer. The safety of these drugs will also be studied.
Pazopanib is designed to block different receptors in the cancer cells that ultimately are responsible for the growth of the tumor and its blood vessels.
Everolimus is designed to block a protein called mTOR inside the cancer cells, which is also involved in cancer growth.
Read the detailed description
Study Groups:
Dose Escalation:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of pazopanib and everolimus based on when you joined this study. Up to 8 dose levels of pazopanib and everolimus will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of pazopanib and everolimus is found.
Expansion:
Once the highest tolerable dose of pazopanib and everolimus is found, up to 14 more participants may be enrolled to further study the safety of the drugs at that dose and the efficacy of the drugs in a certain tumor group.
Study Drug Administration:
Each study cycle is 28 days.
Pazopanib and everolimus are taken by mouth on an empty stomach (1 hour before meals or 2 hours after meals).
On Days 1-5 of Cycle 1 only, you will take pazopanib and everolimus together. First take pazopanib and then take everolimus.
After those first 5 days, you will take pazopanib and everolimus every other day separately. Starting Day 6 of Cycle 1, pazopanib will be taken every even day (6, 8, 10, and so on) . Everolimus will be taken every odd day (7, 9, 11, and so on).
Beginning with Cycle 2, you will take pazopanib every even day (2, 4, 6, and on so) and everolimus every odd day (3, 5, 7, and so on).
Study Visits:
At each study visit, you will be asked what about any drugs or herbal supplements that you may be taking and if you have had any side effects.
On Day 1 of Cycle 1:
- Your medical history will be recorded if it has been more than 3 days since screening.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will have an ECG.
- Blood (about 2 teaspoons) and urine will be collected for routine tests and hepatitis screening.
On Days 8, 15, and 22 of Cycle 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
On Day 1 of Cycles 2 and beyond:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- You will have an ECG.
On Day 15 of Cycle 2:
° Blood (about 2 teaspoons) will be collected for routine tests.
Every 8 weeks:
- You will have a CT scan, x-ray, MRI scan, and/or PET scan to check the status of the disease.
- Blood (about 1 teaspoon) may be drawn for tumor marker testing.
- If you are able to become pregnant, you will have a blood (about ½ teaspoon) or urine pregnancy test.
PK testing:
At least 6 participants in the expansion part of the study will have blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing. The study staff will tell you if you will have this testing. PK testing measures the amount of study drug in the body at different time points.
- On Day 5 of Cycle 1 and Days 1 and 2 of Cycle 2, blood will be drawn before and 8 more times up to 10 hours after taking the study drugs.
- On Day 2 of Cycle 2, blood will be drawn 1 more time for PK testing after 24 hours of taking everolimus. If you could not have the 10 hour draw the day before, this will be drawn at this day.
- On Day 6 of Cycle 1 and Day 3 of Cycle 2, blood will be drawn 1 time for PK testing after 24 hours of taking pazopanib. If you could not have the 10 hour draw the day before, this will be drawn at this day.
- Blood will be drawn 1 time at the end-of-dosing visit.
Length of Study:
You may continue taking the study drugs for as long as you are benefitting. You will be taken off study early if the disease gets worse, intolerable side effects occur, you develop new health problems, or your doctor thinks that it is no longer in your best interest to receive the study drug.
End-of-Dosing Visit:
Within 4 weeks after your last dose of study drugs:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
This is an investigational study. Pazopanib is FDA approved and commercially available for the treatment of advanced renal cancer and certain types of advanced soft tissue sarcoma but has not been approved for use in other cancer types. Everolimus is FDA approved and commercially available for the prevention of kidney transplant rejection, to treat advanced renal cancer, and to treat subependymal giant cell astrocytoma associated with tuberous sclerosis.
The combination of pazopanib and everolimus to treat advanced cancer is investigational.
Up to 62 patients will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers, Solid Tumors
- Being tested
- Pazopanib, Everolimus
- Keywords
- Advanced Cancers, Solid Tumors, PI3KCA Mutation Positive/PTEN, Refractory to standard therapy, Relapsed after standard therapy, Pazopanib, GW786034, Everolimus, Afinitor, RAD001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called GW786034
Starting Dose: 200 mg by mouth on Days 1 - 5 of Cycle 1 only. On Day 6 and every cycle-day with an even number, only pazopanib administered.
EverolimusDrug
Also called Afinitor, RAD001
Starting dose: 5.0 mg by mouth on Days 1 - 5 of Cycle 1. On Day 7 and every cycle-day with an odd number, only everolimus will be administered.
Dose Expansion Phase: Maximum tolerated dose (MTD) from lead in phase.
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib + Everolimus | Experimental | Pazopanib 200 mg and Everolimus 5.0 mg oral dosing every other day (except for lead in 5 days of Cycle 1 where both drugs administered daily). Receives: Drug: Pazopanib; Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Pazopanib and Everolimus
MTD defined as highest dose studied in which the incidence of Dose Limiting Toxicity (DLT) was less than 33%, with no more than 1 of 6 evaluable participants had a DLT using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: 28 days
Secondary outcomes (3)
Response.of Pazopanib and Everolimus
Response evaluated using following criteria: Stable disease for more than or equal to 4 months.
Measured: 4 months
Response.of Pazopanib and Everolimus
Response evaluated using following criteria: Decrease in measurable tumor (target lesions) by more than or equal to 20% by RECIST criteria.
Measured: 4 months
Response.of Pazopanib and Everolimus
Response evaluated using following criteria: Decrease in tumor markers by more than or equal to 25% (for example, a >/= 25% decrease in PSA for patients with prostate cancer.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study start7 Oct 2011
- Primary completion12 May 2020
- Study completion12 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- David S Hong, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430572
- Sponsor's protocol ID
- 2011-0322
- Other IDs
- NCCN-GSKP05, NCI-2011-03040
- Status last verified
- Jun 2023
- First submitted
- 6 Sep 2011
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Combination of Pazopanib and Everolimus in PI3KCA Mutation Positive/PTEN Loss Patients With Advanced Solid Tumors Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT01430572
- Acronym / sponsor ID
- 2011-0322
- Conditions
- Advanced Cancers, Solid Tumors
- Keywords
- Advanced Cancers, Solid Tumors, PI3KCA Mutation Positive/PTEN, Refractory to standard therapy, Relapsed after standard therapy, Pazopanib, GW786034, Everolimus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, National Comprehensive Cancer Network
- Study start
- 7 Oct 2011 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 8 Sep 2011 (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 the combination of Votrient (pazopanib) and Afinitor (everolimus) that can be given to patients with advanced cancer. The safety of these drugs will also be studied.
Pazopanib is designed to block different receptors in the cancer cells that ultimately are responsible for the growth of the tumor and its blood vessels.
Everolimus is designed to block a protein called mTOR inside the cancer cells, which is also involved in cancer growth.
Detailed description
Study Groups:
Dose Escalation:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of pazopanib and everolimus based on when you joined this study. Up to 8 dose levels of pazopanib and everolimus will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of pazopanib and everolimus is found.
Expansion:
Once the highest tolerable dose of pazopanib and everolimus is found, up to 14 more participants may be enrolled to further study the safety of the drugs at that dose and the efficacy of the drugs in a certain tumor group.
Study Drug Administration:
Each study cycle is 28 days.
Pazopanib and everolimus are taken by mouth on an empty stomach (1 hour before meals or 2 hours after meals).
On Days 1-5 of Cycle 1 only, you will take pazopanib and everolimus together. First take pazopanib and then take everolimus.
After those first 5 days, you will take pazopanib and everolimus every other day separately. Starting Day 6 of Cycle 1, pazopanib will be taken every even day (6, 8, 10, and so on) . Everolimus will be taken every odd day (7, 9, 11, and so on).
Beginning with Cycle 2, you will take pazopanib every even day (2, 4, 6, and on so) and everolimus every odd day (3, 5, 7, and so on).
Study Visits:
At each study visit, you will be asked what about any drugs or herbal supplements that you may be taking and if you have had any side effects.
On Day 1 of Cycle 1:
- Your medical history will be recorded if it has been more than 3 days since screening.
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- You will have an ECG.
- Blood (about 2 teaspoons) and urine will be collected for routine tests and hepatitis screening.
On Days 8, 15, and 22 of Cycle 1:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
On Day 1 of Cycles 2 and beyond:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- You will have an ECG.
On Day 15 of Cycle 2:
° Blood (about 2 teaspoons) will be collected for routine tests.
Every 8 weeks:
- You will have a CT scan, x-ray, MRI scan, and/or PET scan to check the status of the disease.
- Blood (about 1 teaspoon) may be drawn for tumor marker testing.
- If you are able to become pregnant, you will have a blood (about ½ teaspoon) or urine pregnancy test.
PK testing:
At least 6 participants in the expansion part of the study will have blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing. The study staff will tell you if you will have this testing. PK testing measures the amount of study drug in the body at different time points.
- On Day 5 of Cycle 1 and Days 1 and 2 of Cycle 2, blood will be drawn before and 8 more times up to 10 hours after taking the study drugs.
- On Day 2 of Cycle 2, blood will be drawn 1 more time for PK testing after 24 hours of taking everolimus. If you could not have the 10 hour draw the day before, this will be drawn at this day.
- On Day 6 of Cycle 1 and Day 3 of Cycle 2, blood will be drawn 1 time for PK testing after 24 hours of taking pazopanib. If you could not have the 10 hour draw the day before, this will be drawn at this day.
- Blood will be drawn 1 time at the end-of-dosing visit.
Length of Study:
You may continue taking the study drugs for as long as you are benefitting. You will be taken off study early if the disease gets worse, intolerable side effects occur, you develop new health problems, or your doctor thinks that it is no longer in your best interest to receive the study drug.
End-of-Dosing Visit:
Within 4 weeks after your last dose of study drugs:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.
This is an investigational study. Pazopanib is FDA approved and commercially available for the treatment of advanced renal cancer and certain types of advanced soft tissue sarcoma but has not been approved for use in other cancer types. Everolimus is FDA approved and commercially available for the prevention of kidney transplant rejection, to treat advanced renal cancer, and to treat subependymal giant cell astrocytoma associated with tuberous sclerosis.
The combination of pazopanib and everolimus to treat advanced cancer is investigational.
Up to 62 patients will be enrolled 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 |
|---|---|---|
| Pazopanib + Everolimus | Experimental | Drug: Pazopanib, Drug: EverolimusPazopanib 200 mg and Everolimus 5.0 mg oral dosing every other day (except for lead in 5 days of Cycle 1 where both drugs administered daily). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
- Patients with advanced or metastatic solid tumors that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
- Patients must have been off previous chemotherapy or radiotherapy for two weeks prior to start of treatment. For biologic/targeted therapies, patients must be >/= five half-lives or >/= 2 weeks from the last treatment dose, whichever comes first. Patients may have received palliative localized radiation immediately before (or during) treatment provided radiation is not delivered to the single target lesion available.
- ECOG performance status </= 2.
- Abnormal organ function is permitted. However, patients must meet the following criteria: neutrophil count >/= 1.5 x 10*9/L; platelets >/= 100 x 10*9/L; creatinine </= 1.5 X upper limit of normal (ULN); T. bilirubin </= 1.5 X ULN; AST(SGOT) and/or ALT(SGPT) </= 2.5 X ULN, UPC < 1.
Key exclusion criteria (14 listed)
- Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anti-convulsants in prior 2 weeks.
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:Active peptic ulcer disease; Known intraluminal metastatic lesion/s with risk of bleeding; Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn's disease),or other gastrointestinal conditions with increased risk of perforation; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior beginning study treatment.
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to; Malabsorption syndrome; Major resection of the stomach or small bowel
- Corrected QT (QTc) > 480 msecs.
- History of any one or more of the following cardiovascular conditions within the past 6 months:Cerebrovascular accident, Myocardial infarction, Unstable angina , Cardiac angioplasty or stenting, Coronary artery bypass graft surgery, Class III or IV heart failure, as defined by the New York Heart Association (NYHA), Untreated pulmonary embolism (PE) or deep venous thrombosis (DVT). Note: subjects with recent PE or DVT who have been therapeutically coagulated for at least 6 weeks are eligible.
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 |
|---|---|---|
| PazopanibAlso: GW786034Starting Dose: 200 mg by mouth on Days 1 - 5 of Cycle 1 only. On Day 6 and every cycle-day with an even number, only pazopanib administered. | Drug | Pazopanib + Everolimus |
| EverolimusAlso: Afinitor, RAD001Starting dose: 5.0 mg by mouth on Days 1 - 5 of Cycle 1. On Day 7 and every cycle-day with an odd number, only everolimus will be administered. Dose Expansion Phase: Maximum tolerated dose (MTD) from lead in phase. | Drug | Pazopanib + Everolimus |
Primary outcome
Maximum Tolerated Dose (MTD) of Pazopanib and Everolimus
Time frame: 28 days
MTD defined as highest dose studied in which the incidence of Dose Limiting Toxicity (DLT) was less than 33%, with no more than 1 of 6 evaluable participants had a DLT using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
3 secondary outcomes
Response.of Pazopanib and Everolimus
Time frame: 4 months
Response.of Pazopanib and Everolimus
Time frame: 4 months
Response.of Pazopanib and Everolimus
Time frame: 4 months
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 6 Jun 2023.
- The University of Texas (UT) MD Anderson Cancer Center Official 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.
David S Hong, 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 Pazopanib and Everolimus in people with Advanced Cancers 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 14 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 6 Jun 2023. 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) of Pazopanib and Everolimus (time frame: 28 days). 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 6 Jun 2023.