Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT01012362

First received: November 12, 2009

Last updated: June 11, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 12, 2009

Last Updated Date

June 11, 2013

Start Date ^ICMJE

December 2009

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the optimal tolerated regimen (OTR) of pazopanib and ixabepilone when used in combination by evaluation of toxicity and tolerability [ Time Frame: At first cycle (Week 3) ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01012362 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To obtain preliminary toxicity and tolerability of this drug regimen. [ Time Frame: Up to 30 days post treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

Official Title ^ICMJE

Phase I Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

Brief 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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: Pazopanib
Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.
Other Names:
- Pazopanib hydrochloride
- GW786034B
Drug: Ixabepilone
Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle

Other Name: IXEMPRA(TM)

Study Arm (s)

Experimental: Pazopanib and Ixabepilone

Patient receives assigned dose level:

Dose Level 1 = 400 milligrams (mg) of pazopanib and ixabepilone 25 mg/m2. Dose Level 2 = 400 milligrams (mg) of pazopanib and ixabepilone 32 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.

Interventions:

Drug: Pazopanib
Drug: Ixabepilone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2013

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01012362

Other Study ID Numbers ^ICMJE

2009LS001, 0906M68402, NCI-2009-01444

Has Data Monitoring Committee

Yes

Responsible Party

Masonic Cancer Center, University of Minnesota

Study Sponsor ^ICMJE

Masonic Cancer Center, University of Minnesota

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Arkaduisz Z Dudek, MD

Masonic Cancer Center, University of Minnesota

Information Provided By

Masonic Cancer Center, University of Minnesota

Verification Date

June 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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