Study of Pazopanib and Ixabepilone in Patients With Solid Tumors

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPazopanib and Ixabepilone

The study team can explain what participation involves.

Who it may be forBreast Cancer · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 28, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

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What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Masonic Cancer Center, University of Minnesota

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Masonic Cancer Center, University of Minnesota
Interventions being studied: Drug: Pazopanib; Drug: Ixabepilone

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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/

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 28, 2017. Always confirm current availability with the study team.

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