Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

NCT ID: NCT01012362

Last Updated: 2017-12-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2013-02-28

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.

Conditions

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

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Pazopanib

Intervention Type: DRUG

Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.

Ixabepilone

Intervention Type: DRUG

Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle

Optimum Tolerated Dose Confirmation

Dose Level 3 = 600 milligrams (mg) of pazopanib and ixabepilone 32 mg/m2.

Group Type: EXPERIMENTAL

Pazopanib

Intervention Type: DRUG

Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.

Ixabepilone

Intervention Type: DRUG

Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle

Interventions

Pazopanib

Escalating doses 400-800 mg by mouth once daily beginning day 1 and continuing.

Intervention Type: DRUG

Ixabepilone

Escalating doses 25-32 mg/m2 by intravenous infusion on day 1 of each 21 day cycle

Intervention Type: DRUG

Other Intervention Names

Pazopanib hydrochloride; GW786034B; IXEMPRA(TM)

Eligibility Criteria

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arkaduisz Z Dudek, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0906M68402

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2009-01444

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009LS001

Identifier Type: -

Identifier Source: org_study_id