CompletedPhase 2NCT01253369
Official study title

Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer

Study summary

Pazopanib is a drug that inhibits proteins thought to be important for new blood vessel formation. This drug has been used in other cancer research studies and information from those studies suggests that pazopanib may help block proteins that are important for the growth, invasion, and spread of cancer cells.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPazopanib

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 23, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Dana-Farber Cancer Institute

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Dana-Farber Cancer Institute
Interventions being studied
Drug: Pazopanib
02
Explore related studies

How this study is categorized

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

03
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 small cell neuroendocrine carcinoma based on either histology or cytology with radiologically-confirmed progressive disease.
  • Participants should have received first-line chemotherapy and may have had up to two prior chemotherapy regimens. Radiation therapy may have been part of the permitted prior therapy.
  • Participants with brain metastases will be allowed if they have been treated with surgery and/or radiation therapy more than 21 days prior, are asymptomatic, and are stable for at least one week off steroids.
  • 18 years of age or older
  • ECOG Performance status of 0, 1 or 2
  • Ability to swallow and retain oral medication
  • Disease must be measurable according to RECIST 1.1
  • Adequate organ function as defined in the protocol
Reasons someone may not be able to joinExclusion criteria
  • Prior malignancy except for participants that have been disease-free for 3 years or with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
  • History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to first dose of study drug.
  • Clinically significant gastrointestinal abnormalities
  • Presence of uncontrolled infection
  • Prolongation of corrected QT interval (QTc) \> 480msecs
  • History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting; myocardial infarction; unstable angina; symptomatic peripheral vascular disease; Class III or IV congestive heart failure
  • Poorly controlled hypertension
  • History of cerebrovascular accident including transient ischemic attack, pulmonary embolism or insufficiently treated deep venous thrombosis within the past 6 months
  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer
  • Evidence of active bleeding or bleeding diathesis
  • Hemoptysis in excess of 2.5mL within 6 weeks of first dose of study drug
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
  • Use of any prohibited medication within the timeframes listed in the protocol
  • Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
  • Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors
  • Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy
  • Any ongoing toxicity from prior anti-cancer therapy that is \> Grade 1 and/or that is progressing in severity
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib

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

04
Study sites

U.S. locations

  • Massachusetts General HospitalBoston, Massachusetts
  • Beth Israel Deaconess Medical CenterBoston, Massachusetts
  • Dana-Farber Cancer InstituteBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 23, 2019. Always confirm current availability with the study team.

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