Breast CancerPhase 1NCT01012362
Study of Pazopanib and Ixabepilone in Patients With Solid Tumors
A Phase 1 study testing Pazopanib and Ixabepilone in people with Breast Cancer and Lung Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a Phase I study; dose escalating the combination of pazopanib when taken daily and ixabepilone when administered on day 1 of a 3 week treatment course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Colon Cancer
- What is being tested?
- Pazopanib and Ixabepilone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Feb 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of advanced non-hematologic solid tumor malignancy, including, but not limited to breast, lung, colon, pancreatic, head and neck, kidney or sarcoma that has failed or become intolerant to standard therapy and is no longer likely to respond to such therapy Effective with the August 2011 version of the protocol, enrollment is limited to squamous cell carcinoma of the head and neck (refer to section 1.4 for rationale). Note: Patients with a primary diagnosis of hepatocellular carcinoma will be eligible for enrollment into dose level 1 or 2 only, provided they met all other inclusion/exclusion criteria - the maximum tolerated dose (MTD) for pazopanib monotherapy in patients with hepatocellular cancer was found to be 600 mg daily.
- Measureable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
- Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed; however prior use of either pazopanib or ixabepilone alone or in combination is not allowed.
- At least 14 days must have elapsed since 1) previous systemic therapy (28 days for bevacizumab) before the 1st dose of study drug, 2) last dose of radiation therapy or surgery (28 days for major surgery).
- Patient must have recovered from the acute toxic effects of previous anti-cancer treatment prior to study enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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- Adequate organ function within 14 days of enrollment defined as:
- Absolute neutrophil count (ANC) >1.5 x 10^9/L
- Hemoglobin > or = 9 g/dL
- Platelets > or = 100 x 10^9/L
- Prothrombin time or international normalized ratio, and partial thromboplastin time (PTT) < or = 1.2 x upper limit of normal (ULN)
- Total bilirubin < or = ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = 2.5 x ULN
- Serum creatinine < or = 1.5 mg/dL
- Urine protein to Creatinine Ratio < 1
- Total serum calcium < 12.0 mg/dL
- Men and women with child-bearing potential must adhere to protocol criteria to prevent conception during study
Who cannot join
- Women who are pregnant or nursing.
- Prior radiation to > =or = 30% of major bone marrow containing areas (pelvis, lumbar spine)
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis
- Clinically significant gastrointestinal abnormalities that may increase the risk of GI bleeding or may affect absorption of investigational product
- History of another malignancy - must be at least 3 years disease-free
- Presence of uncontrolled infection
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- Prolongation of corrected QT interval (QTc) > 480 msecs
- History of any one or more of the following cardiovascular conditions within the past 6 months:
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Coronary artery bypass graft surgery
- Symptomatic peripheral vascular disease
- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- Poorly controlled hypertension
- History of cerebrovascular accident,pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- Prior major surgery or trauma within 28 days prior to 1st dose of study drug
- Evidence of active bleeding or bleeding diathesis
- Known endobronchial lesions or involvement of large pulmonary vessels by tumor
- Hemoptysis with 6 weeks of 1st dose of study drug
- Neuropathy Grade 1
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase I Study of Pazopanib and Ixabepilone in Patients With Solid Tumors
This is a Phase I study; dose escalating the combination of pazopanib when taken daily and ixabepilone when administered on day 1 of a 3 week treatment course.
Read the detailed description
Treatment with ixabepilone will be given at an assigned dose as a 3 hour intravenous infusion on day 1 of a 21 day cycle. Treatment with pazopanib will be given at an assigned dose by mouth once a day, beginning on day 1 and continuing daily. Disease assessment will be done every 2 cycles (6 weeks) with treatment continuing until disease progression, unacceptable toxicity or patient refusal.
- Conditions
- Breast Cancer, Lung Cancer, Colon Cancer, Pancreatic Cancer, Head and Neck Cancer, Kidney Cancer
- Being tested
- Pazopanib, Ixabepilone
- Keywords
- Solid tumor malignancy, breast cancer, lung cancer, colon cancer, pancreatic cancer, head and neck cancer, kidney cancer, sarcoma, hepatocellular cancer
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Head and Neck Neoplasms, Kidney Neoplasms, Sarcoma, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Also called Pazopanib hydrochloride, GW786034B
Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.
IxabepiloneDrug
Also called IXEMPRA(TM)
Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Optimum Tolerated Dose Determination | Experimental | Patient receives assigned dose level:
Dose Level 1 = 400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 2 = 400 milligrams (mg) of pazopanib and ixabepilone 40 mg/m2. Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 4 = 800 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Receives: Drug: Pazopanib; Drug: Ixabepilone |
| Optimum Tolerated Dose Confirmation | Experimental | Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Receives: Drug: Pazopanib; Drug: Ixabepilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination
The optimal tolerated regimen is the regimen where ≤ 1 out of 6 patients experiences a dose limiting toxicity (DLT). DLT is defined as one of the following events occurring during cycle 1: grade 4 or greater treatment related hematologic toxicity for > 7 days during the first cycle (21 days) of therapy; grade 3 or greater treatment related clinical non-hematological toxicity (excluding ≥ grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis) during the first cycle (21 days) of therapy; or a delay of cycle 2 treatment start by more than 2 weeks due to incomplete hematologic recovery (ANC > 1.5 x 109/L or platelets 100 x 109/L) or unresolved treatment related grade 3 or greater non-hematologic toxicity.
Measured: Week 3 of each dose level
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
A DLT was defined as one of the following events occurring during cycle 1: (1) grade 4 or greater treatment-related hematologic toxicity for >7 days; (2) grade 3 or greater treatment-related clinical non-hematologic toxicity (excluding >/= grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis); or (3) delay of starting cycle 2 treatment by >2 weeks due to incomplete hematologic recovery (absolute neutrophil count > 1.5 X 10^9/L or platelets >100 X 10^9/L) or unresolved treatment-related grade 3 or greater non-hematologic toxicity. Adverse events were classified according to Common Terminology Criteria for Adverse Events V 3.0 (CTCAE).
Measured: Week 3 of each dose
Secondary outcomes (1)
Number of Participants With Treatment-Related Adverse Events
Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.
Measured: Up to 30 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: PI left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Arkaduisz Z Dudek, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012362
- Sponsor's protocol ID
- 2009LS001
- Other IDs
- 0906M68402, NCI-2009-01444
- Status last verified
- Dec 2017
- First submitted
- 12 Nov 2009
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Pazopanib and Ixabepilone in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT01012362
- Acronym / sponsor ID
- 2009LS001
- Conditions
- Breast Cancer, Lung Cancer, Colon Cancer, Pancreatic Cancer, Head and Neck Cancer, Kidney Cancer
- Keywords
- Solid tumor malignancy, breast cancer, lung cancer, colon cancer, pancreatic cancer, head and neck cancer, kidney cancer, sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I study; dose escalating the combination of pazopanib when taken daily and ixabepilone when administered on day 1 of a 3 week treatment course.
Detailed description
Treatment with ixabepilone will be given at an assigned dose as a 3 hour intravenous infusion on day 1 of a 21 day cycle. Treatment with pazopanib will be given at an assigned dose by mouth once a day, beginning on day 1 and continuing daily. Disease assessment will be done every 2 cycles (6 weeks) with treatment continuing until disease progression, unacceptable toxicity or patient refusal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimum Tolerated Dose Determination | Experimental | Drug: Pazopanib, Drug: IxabepilonePatient receives assigned dose level: Dose Level 1 = 400 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 2 = 400 milligrams (mg) of pazopanib and ixabepilone 40 mg/m2. Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. Dose Level 4 = 800 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. |
| Optimum Tolerated Dose Confirmation | Experimental | Drug: Pazopanib, Drug: IxabepiloneDose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosis of advanced non-hematologic solid tumor malignancy, including, but not limited to breast, lung, colon, pancreatic, head and neck, kidney or sarcoma that has failed or become intolerant to standard therapy and is no longer likely to respond to such therapy Effective with the August 2011 version of the protocol, enrollment is limited to squamous cell carcinoma of the head and neck (refer to section 1.4 for rationale). Note: Patients with a primary diagnosis of hepatocellular carcinoma will be eligible for enrollment into dose level 1 or 2 only, provided they met all other inclusion/exclusion criteria - the maximum tolerated dose (MTD) for pazopanib monotherapy in patients with hepatocellular cancer was found to be 600 mg daily.
- Measureable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
- Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed; however prior use of either pazopanib or ixabepilone alone or in combination is not allowed.
- At least 14 days must have elapsed since 1) previous systemic therapy (28 days for bevacizumab) before the 1st dose of study drug, 2) last dose of radiation therapy or surgery (28 days for major surgery).
- Patient must have recovered from the acute toxic effects of previous anti-cancer treatment prior to study enrollment.
Key exclusion criteria (21 listed)
- Women who are pregnant or nursing.
- Prior radiation to > =or = 30% of major bone marrow containing areas (pelvis, lumbar spine)
- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis
- Clinically significant gastrointestinal abnormalities that may increase the risk of GI bleeding or may affect absorption of investigational product
- History of another malignancy - must be at least 3 years disease-free
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: Pazopanib hydrochloride, GW786034BEscalating doses 400-800 mg by mouth once daily beginning day 1 and continuing. | Drug | Optimum Tolerated Dose Confirmation, Optimum Tolerated Dose Determination |
| IxabepiloneAlso: IXEMPRA(TM)Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle | Drug | Optimum Tolerated Dose Confirmation, Optimum Tolerated Dose Determination |
Primary outcome
The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination
Time frame: Week 3 of each dose level
The optimal tolerated regimen is the regimen where ≤ 1 out of 6 patients experiences a dose limiting toxicity (DLT). DLT is defined as one of the following events occurring during cycle 1: grade 4 or greater treatment related hematologic toxicity for > 7 days during the first cycle (21 days) of therapy; grade 3 or greater treatment related clinical non-hematological toxicity (excluding ≥ grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis) during the first cycle (21 days) of therapy; or a delay of cycle 2 treatment start by more than 2 weeks due to incomplete hematologic recovery (ANC > 1.5 x 109/L or platelets 100 x 109/L) or unresolved treatment related grade 3 or greater non-hematologic toxicity.
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Time frame: Week 3 of each dose
A DLT was defined as one of the following events occurring during cycle 1: (1) grade 4 or greater treatment-related hematologic toxicity for >7 days; (2) grade 3 or greater treatment-related clinical non-hematologic toxicity (excluding >/= grade 3 nausea, vomiting, or diarrhea without maximal medical intervention and/or prophylaxis); or (3) delay of starting cycle 2 treatment by >2 weeks due to incomplete hematologic recovery (absolute neutrophil count > 1.5 X 10^9/L or platelets >100 X 10^9/L) or unresolved treatment-related grade 3 or greater non-hematologic toxicity. Adverse events were classified according to Common Terminology Criteria for Adverse Events V 3.0 (CTCAE).
1 secondary outcome
Number of Participants With Treatment-Related Adverse Events
Time frame: Up to 30 days post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Arkaduisz Z Dudek, MD principal investigator
Masonic Cancer Center, University of Minnesota
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 Ixabepilone in people with Breast Cancer and Lung Cancer, run by Masonic Cancer Center, University of Minnesota 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 17 inclusion and 21 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: stopped early, as of the sponsor's last update on 28 Dec 2017. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination (time frame: Week 3 of each dose level). 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 28 Dec 2017.