TerminatedNCT01012362Updated Dec 28, 2017Results posted

Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

A Phase 1 interventional study of Pazopanib and Ixabepilone in Breast Cancer, Lung Cancer and Colon Cancer, sponsored by Masonic Cancer Center, University of Minnesota. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-28.

Sponsored by Masonic Cancer Center, University of Minnesota · Phase 1, Interventional, and Treatment

Why this study was terminated

PI left institution.

Phase: Phase 1
Study type: Interventional
Enrollment: 31
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Breast Cancer
Lung Cancer
Colon Cancer
Pancreatic Cancer
Head and Neck Cancer
Kidney Cancer
Sarcoma
Hepatocellular Cancer

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Keywords

Solid tumor malignancy
breast cancer
lung cancer
colon cancer
pancreatic cancer
head and neck cancer
kidney cancer
sarcoma
hepatocellular cancer

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 31 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.
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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 31 participants (actual)

Study arms

Experimental
Optimum Tolerated Dose Determination
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.
Drug: Pazopanib · Drug: Ixabepilone
Experimental
Optimum Tolerated Dose Confirmation
Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.
Drug: Pazopanib · Drug: Ixabepilone

Interventions

DrugPazopanib
Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.
Also known as: Pazopanib hydrochloride, GW786034B
DrugIxabepilone
Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle
Also known as: IXEMPRA(TM)

What researchers measure

Primary outcomes

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.
Time frame: 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).
Time frame: Week 3 of each dose

Secondary outcomes

Number of Participants With Treatment-Related Adverse Events
Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.
Time frame: Up to 30 days post treatment

Results

Posted Jun 26, 2017

Participant flow

Participant flow — Overall Study
Milestone	Arm 1: Dose Level 1	Arm 1: Dose Level 2	Arm 1: Dose Level 3	Arm 1: Dose Level 4	Arm 2
Started	9	6	3	4	9
Completed	9	6	3	4	9
Not completed	0	0	0	0	0

Outcome measures

PrimaryThe 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.

Time frame:: Week 3 of each dose level
Reported as:: Number · Dose Level

The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination
Dose Level	All Arm 1 Participants
The Optimal Tolerated Regimen of Pazopanib and Ixabepilone When Used in Combination	3

PrimaryNumber 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).

Time frame:: Week 3 of each dose
Reported as:: Count of participants · Participants

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Participants	Arm 1: Dose Level 1	Arm 1: Dose Level 2	Arm 1: Dose Level 3	Arm 1: Dose Level 4	Arm 2: Dose Level 3
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)	0	3	0	1	2

SecondaryNumber of Participants With Treatment-Related Adverse Events

Includes all treatment-related adverse events experienced during and subsequent to Cycle 1.

Time frame:: Up to 30 days post treatment
Reported as:: Count of participants · Participants

Number of Participants With Treatment-Related Adverse Events
Participants	Dose Level 1	Dose Level 2	Dose Level 3	Dose Level 4
Number of Participants With Treatment-Related Adverse Events	9	6	12	4

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dose Level 1	—	4/9 (44.4%)	9/9 (100%)
Dose Level 2	—	3/6 (50%)	6/6 (100%)
Dose Level 3	—	7/12 (58.3%)	12/12 (100%)
Dose Level 4	—	3/4 (75%)	4/4 (100%)

Most frequent serious events

Showing 10 of 15

Most frequent serious events
Event	Dose Level 1	Dose Level 2	Dose Level 3	Dose Level 4
InfectionInfections and infestations	0/9	1/6	3/12	0/4
FatigueGeneral disorders	0/9	0/6	0/12	1/4
Decreased PlateletsBlood and lymphatic system disorders	0/9	0/6	0/12	1/4
Atrial fibrillationCardiac disorders	0/9	0/6	0/12	1/4
Obstruction of AirwayRespiratory, thoracic and mediastinal disorders	0/9	0/6	0/12	1/4
Respiratory FailureRespiratory, thoracic and mediastinal disorders	0/9	0/6	0/12	1/4
Muscle WeaknessMusculoskeletal and connective tissue disorders	0/9	1/6	0/12	0/4
Death due to Disease ProgressionGeneral disorders	0/9	1/6	0/12	0/4
SyncopeNervous system disorders	1/9	0/6	0/12	0/4
Febrile NeutropeniaBlood and lymphatic system disorders	1/9	0/6	1/12	0/4

Most frequent other events

Showing 10 of 120

Most frequent other events
Event	Dose Level 1	Dose Level 2	Dose Level 3	Dose Level 4
NeutropeniaBlood and lymphatic system disorders	6/9	6/6	4/12	1/4
FatigueGeneral disorders	4/9	4/6	10/12	3/4
NauseaGastrointestinal disorders	5/9	3/6	9/12	2/4
Abdominal PainGastrointestinal disorders	0/9	0/6	6/12	0/4
AlopeciaSkin and subcutaneous tissue disorders	1/9	3/6	4/12	0/4
AnemiaBlood and lymphatic system disorders	2/9	3/6	2/12	1/4
AnorexiaMetabolism and nutrition disorders	3/9	3/6	5/12	2/4
ConstipationGastrointestinal disorders	2/9	2/6	1/12	2/4
DiarrheaGastrointestinal disorders	3/9	2/6	6/12	0/4
VomitingGastrointestinal disorders	3/9	2/6	6/12	2/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Arm 1: Dose Level 1	Arm 1: Dose Level 2	Arm 1: Dose Level 3	Arm 1: Dose Level 4	Arm 2	Total
<=18 years	0	0	0	0	0	0
Between 18 and 65 years	6	5	3	3	7	24
>=65 years	3	1	0	1	2	7

Sex: Female, Male
Sex: Female, Male(Participants)	Arm 1: Dose Level 1	Arm 1: Dose Level 2	Arm 1: Dose Level 3	Arm 1: Dose Level 4	Arm 2	Total
Female	6	1	1	1	2	11
Male	3	5	2	3	7	20

Study locations

1 site

Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota 55455, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01012362
Lead sponsor: Masonic Cancer Center, University of Minnesota
Collaborators: GlaxoSmithKline
Responsible party: Sponsor
First posted: Nov 13, 2009
Start date: Dec 2009
Primary completion: Feb 2013
Completion: Feb 2013
Results posted: Jun 26, 2017
Last update: Dec 28, 2017

Study contacts

Arkaduisz Z Dudek, MD

principal investigator · Masonic Cancer Center, University of Minnesota

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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