Advanced CancersPhase 1NCT01454804
Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors
A Phase 1 study testing Pazopanib, Lapatinib and Trastuzumab (Herceptin®) in people with Advanced Cancers, 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 combinations of pazopanib and either lapatinib or trastuzumab that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Pazopanib, Lapatinib and Trastuzumab (Herceptin®)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Mar 2015
- 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 with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months.
- Patients must have measurable or evaluable disease.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Abnormal organ function is permitted; however, patients must have : Plt >/=100,000/, absolute neutrophil count (ANC) >/=1500, total Bilirubin </=2.0 mg/dl, Creatinine </=2.0 mg/dl and Prothrombin Time/International Normalized Ratio/Partial Thromboplastin Time (PT/INR/PTT) within 1.5 X upper limit of normal (ULN).
- A woman is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation, is post-menopausal (total cessation of menses for ≥ 1 year); OR if of childbearing potential, has a negative serum pregnancy test at screening, and agrees to use adequate contraception.
- A man with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study.
- Signed informed consent approved by the Institutional Review Board prior to patient entry.
- Expanded Cohort only: Patients must have HER2 amplification, HER2 mutation, c-Met amplification, c-Met mutation, EML4-ALK translocation, or epidermal growth factor receptor (EGFR) mutation.
Who cannot join
- Poorly-controlled hypertension (systolic blood pressure [SBP] >/= 140 mmHg, or diastolic blood pressure [DBP]>/= 90 mmHg).
- Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes,congestive cardiac failure )
- History of myocardial infarction, admission for unstable angina, cardiac angioplasty or stenting within three months of Day 1 of treatment period.
- History of venous or arterial thrombosis within 3 months of Day 1 of treatment Period.
- Current use of therapeutic warfarin. NOTE: both low molecular weight heparin and prophylactic low-dose warfarin are permitted; however, PT/PTT must meet above inclusion criteria.
- Excessive risk of bleeding or thrombosis as defined by stroke or severe bleeding within the prior 6 months.
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- Patients who received investigational drugs, chemotherapy or immunotherapy patient must be >/= five half-lives or >/= 3 weeks from the last dose of treatment, whichever is shorter.
- Any major surgery or radiotherapy within 14 days of treatment.
- Patients with a documented Left Ventricular Ejection Fraction < 45%.
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 Study of Pazopanib in Combination With Lapatinib or Trastuzumab in Subjects With Solid Tumors
The goal of this clinical research study is to find the highest tolerable dose of the combinations of pazopanib and either lapatinib or trastuzumab that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells.
Read more
Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking 2 proteins on the surface of the cancer cell, which are HER 1 and HER 2 receptors.
Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell, called the Her2/neu receptor.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, your doctor will decide which study drugs you will receive based on the disease type and the drugs you have taken in the past
You will receive either a combination of pazopanib and lapatinib (Arm A) or a combination of pazopanib and trastuzumab (Arm B).
Up to 5 dose levels of each combination will be tested. Up to 6 participants will be enrolled at each dose level of each combination. The first group of participants will receive the lowest dose level of each combination. Each new group(s) will receive a higher combination than the group before it, if no intolerable side effects were seen. Participants may be enrolled on 1-3 similar dose levels at the same time. You will be assigned to a dose level based on when you joined this study. This will continue until the highest tolerable dose(s) of the study drug combination is found.
The dose of the study drug combination that you receive may be lowered if you have intolerable side effects.
Once the highest tolerable doses of the different combinations are found, this dose of each combination will be given to an expansion group of 20 extra participants.
Study Drug Administration:
If you are in Arm A, you will take lapatinib by mouth 1 time each day. You will take pazopanib by mouth 1 time every other day (Day 1, 3, 5, and so on). You should take pazopanib and lapatinib either 1 hour before or 2 hours after eating a meal.
If you are in Arm B, you will take pazopanib by mouth 1 time each day. You will receive trastuzumab by vein on Days 1, 8, 15, and 22 of each cycle. The first infusion will be over 90 minutes. If you handle the infusion well, the next infusions will be over 30 minutes. You should take pazopanib either 1 hour before or 2 hours after eating a meal.
Each study cycle is 28 days.
Study Visits:
At all study visits, you will be asked about any drugs you may be taking and side effects you may be having.
Week 3 of Cycle 1, blood (about 1 teaspoon) and urine will be collected for routine tests.
During Week 3 of Cycles 2 and beyond, blood (about 1 teaspoon) will be drawn for routine tests.
During Week 4 of Cycle 2 and then every 2-3 cycles:
- You will have a CT scan, MRI scan, PET scan, and/or x-ray to check the status of the disease.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will be taken off study early if the disease gets worse, if you continue to have intolerable side effects, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
Within 30 days after your last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests and procedures performed:
- Your medical history will be recorded.
- You will have a physical exam.
- You will be asked about any drugs you may be taking and side effects you may be having.
- Your weight, vital signs, and performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
- If the study doctor thinks it is needed, you will have a chest x-ray, CT scan, MRI scan, and/or PET scan to check the status of the disease.
This is an investigational study. Pazopanib is FDA approved and commercially available for the treatment of renal cell carcinoma. Lapatinib and trastuzumab are FDA approved and commercially available for the treatment of breast cancer. The combination of pazopanib and lapatinib or pazopanib and trastuzumab is investigational.
Up to 174 participants will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- Pazopanib, Lapatinib, Trastuzumab (Herceptin®)
- Keywords
- Advanced Cancers, Solid Tumors, Pazopanib, GW786034, Lapatinib, Tykerb, GW572016, Trastuzumab, Herceptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called GW78634
Starting dose: 200 mg by mouth every other day starting on day 1 for 28 days.
LapatinibDrug
Also called Tykerb, GW572016
Starting dose 500 mg by mouth every day for 28 days.
Trastuzumab (Herceptin®)Drug
Also called Herceptin
4 mg/kg loading dose as a 90 minute infusion by vein on day 1 of cycle 1.
Maintenance dose of 2 mg/kg every week as 30 minute infusion by vein.
Dose Expansion Phase: Maximum tolerated dose (MTD) from Dose Escalation Phase
PazopanibDrug
Also called GW78634
Starting dose 200 mg by mouth every day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Pazopanib + Lapatinib | Experimental | Oral Pazopanib 200 mg every other day starting on day 1 and oral Lapatinib 500 mg daily starting day 1, both for 28 days. Receives: Drug: Pazopanib; Drug: Lapatinib |
| Arm B: Pazopanib + Trastuzumab | Experimental | Oral Pazopanib 200 mg daily for 28 day cycle and Trastuzumab (Herceptin®) 4 mg/kg loading dose as a 90 minute infusion by vein on day 1 of cycle 1, with a maintenance dose of 2 mg/kg every week as 30 minute infusion by vein. Receives: Drug: Trastuzumab (Herceptin®); Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Pazopanib in Combination with Lapatinib or Trastuzumab
MTD is defined as highest dose in which incidence of dose limiting toxicity (DLT) was less than 33% (approximately two or more participants in a dose cohort).
Measured: 28 day cycle
Tumor Response
Computed tomography (CT) scan, magnetic resonance imaging (MRI) scan, positron emission tomography (PET) scan, and/or x-ray to check the status of the disease. Tumor response calculated by Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization Working Group (WHO) criteria. A tumor response is defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by RECIST criteria, (3) decrease in tumor markers by more than or equal to 25% or (4) a partial response according to the Choi criteria.
Measured: End of second 28 day cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2015
- Study completionMar 2015
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David S. Hong, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454804
- Sponsor's protocol ID
- 2011-0650
- Other IDs
- NCI-2011-03450
- Status last verified
- Mar 2015
- First submitted
- 12 Oct 2011
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Pazopanib in Combination With Lapatinib or Trastuzumab in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01454804
- Acronym / sponsor ID
- 2011-0650
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Solid Tumors, Pazopanib, GW786034, Lapatinib, Tykerb, GW572016, Trastuzumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Oct 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 combinations of pazopanib and either lapatinib or trastuzumab that can be given to patients with advanced cancer. The safety of the drug combinations will also be studied.
Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells.
Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking 2 proteins on the surface of the cancer cell, which are HER 1 and HER 2 receptors.
Trastuzumab is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell, called the Her2/neu receptor.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, your doctor will decide which study drugs you will receive based on the disease type and the drugs you have taken in the past
You will receive either a combination of pazopanib and lapatinib (Arm A) or a combination of pazopanib and trastuzumab (Arm B).
Up to 5 dose levels of each combination will be tested. Up to 6 participants will be enrolled at each dose level of each combination. The first group of participants will receive the lowest dose level of each combination. Each new group(s) will receive a higher combination than the group before it, if no intolerable side effects were seen. Participants may be enrolled on 1-3 similar dose levels at the same time. You will be assigned to a dose level based on when you joined this study. This will continue until the highest tolerable dose(s) of the study drug combination is found.
The dose of the study drug combination that you receive may be lowered if you have intolerable side effects.
Once the highest tolerable doses of the different combinations are found, this dose of each combination will be given to an expansion group of 20 extra participants.
Study Drug Administration:
If you are in Arm A, you will take lapatinib by mouth 1 time each day. You will take pazopanib by mouth 1 time every other day (Day 1, 3, 5, and so on). You should take pazopanib and lapatinib either 1 hour before or 2 hours after eating a meal.
If you are in Arm B, you will take pazopanib by mouth 1 time each day. You will receive trastuzumab by vein on Days 1, 8, 15, and 22 of each cycle. The first infusion will be over 90 minutes. If you handle the infusion well, the next infusions will be over 30 minutes. You should take pazopanib either 1 hour before or 2 hours after eating a meal.
Each study cycle is 28 days.
Study Visits:
At all study visits, you will be asked about any drugs you may be taking and side effects you may be having.
Week 3 of Cycle 1, blood (about 1 teaspoon) and urine will be collected for routine tests.
During Week 3 of Cycles 2 and beyond, blood (about 1 teaspoon) will be drawn for routine tests.
During Week 4 of Cycle 2 and then every 2-3 cycles:
- You will have a CT scan, MRI scan, PET scan, and/or x-ray to check the status of the disease.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will be taken off study early if the disease gets worse, if you continue to have intolerable side effects, or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-study visit.
End-of-Study Visit:
Within 30 days after your last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests and procedures performed:
- Your medical history will be recorded.
- You will have a physical exam.
- You will be asked about any drugs you may be taking and side effects you may be having.
- Your weight, vital signs, and performance status will be recorded.
- Blood (about 2 teaspoons) and urine will be collected for routine tests.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers.
- If the study doctor thinks it is needed, you will have a chest x-ray, CT scan, MRI scan, and/or PET scan to check the status of the disease.
This is an investigational study. Pazopanib is FDA approved and commercially available for the treatment of renal cell carcinoma. Lapatinib and trastuzumab are FDA approved and commercially available for the treatment of breast cancer. The combination of pazopanib and lapatinib or pazopanib and trastuzumab is investigational.
Up to 174 participants will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Pazopanib + Lapatinib | Experimental | Drug: Pazopanib, Drug: LapatinibOral Pazopanib 200 mg every other day starting on day 1 and oral Lapatinib 500 mg daily starting day 1, both for 28 days. |
| Arm B: Pazopanib + Trastuzumab | Experimental | Drug: Trastuzumab (Herceptin®), Drug: PazopanibOral Pazopanib 200 mg daily for 28 day cycle and Trastuzumab (Herceptin®) 4 mg/kg loading dose as a 90 minute infusion by vein on day 1 of cycle 1, with a maintenance dose of 2 mg/kg every week as 30 minute infusion by vein. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months.
- Patients must have measurable or evaluable disease.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
- Abnormal organ function is permitted; however, patients must have : Plt >/=100,000/, absolute neutrophil count (ANC) >/=1500, total Bilirubin </=2.0 mg/dl, Creatinine </=2.0 mg/dl and Prothrombin Time/International Normalized Ratio/Partial Thromboplastin Time (PT/INR/PTT) within 1.5 X upper limit of normal (ULN).
- A woman is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation, is post-menopausal (total cessation of menses for ≥ 1 year); OR if of childbearing potential, has a negative serum pregnancy test at screening, and agrees to use adequate contraception.
Key exclusion criteria (9 listed)
- Poorly-controlled hypertension (systolic blood pressure [SBP] >/= 140 mmHg, or diastolic blood pressure [DBP]>/= 90 mmHg).
- Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes,congestive cardiac failure )
- History of myocardial infarction, admission for unstable angina, cardiac angioplasty or stenting within three months of Day 1 of treatment period.
- History of venous or arterial thrombosis within 3 months of Day 1 of treatment Period.
- Current use of therapeutic warfarin. NOTE: both low molecular weight heparin and prophylactic low-dose warfarin are permitted; however, PT/PTT must meet above inclusion criteria.
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: GW78634Starting dose: 200 mg by mouth every other day starting on day 1 for 28 days. | Drug | Arm A: Pazopanib + Lapatinib |
| LapatinibAlso: Tykerb, GW572016Starting dose 500 mg by mouth every day for 28 days. | Drug | Arm A: Pazopanib + Lapatinib |
| Trastuzumab (Herceptin®)Also: Herceptin4 mg/kg loading dose as a 90 minute infusion by vein on day 1 of cycle 1. Maintenance dose of 2 mg/kg every week as 30 minute infusion by vein. Dose Expansion Phase: Maximum tolerated dose (MTD) from Dose Escalation Phase | Drug | Arm B: Pazopanib + Trastuzumab |
| PazopanibAlso: GW78634Starting dose 200 mg by mouth every day for 28 days. | Drug | Arm B: Pazopanib + Trastuzumab |
Primary outcome
Maximum Tolerated Dose (MTD) of Pazopanib in Combination with Lapatinib or Trastuzumab
Time frame: 28 day cycle
MTD is defined as highest dose in which incidence of dose limiting toxicity (DLT) was less than 33% (approximately two or more participants in a dose cohort).
Tumor Response
Time frame: End of second 28 day cycle
Computed tomography (CT) scan, magnetic resonance imaging (MRI) scan, positron emission tomography (PET) scan, and/or x-ray to check the status of the disease. Tumor response calculated by Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization Working Group (WHO) criteria. A tumor response is defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by RECIST criteria, (3) decrease in tumor markers by more than or equal to 25% or (4) a partial response according to the Choi criteria.
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 13 Apr 2016.
- University of Texas 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.
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, Lapatinib and Trastuzumab (Herceptin®) in people with Advanced Cancers, 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 8 inclusion and 9 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 13 Apr 2016. 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 in Combination with Lapatinib or Trastuzumab (time frame: 28 day cycle). The study lists 2 primary outcomes in all. 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 13 Apr 2016.