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A Phase II Study of Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Small Cell Lung Cancer, Lung Cancer, SCLC

Thank you

Trial Information

A Phase II Study of Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)


- All participants will take pazopanib tablets once daily. Each treatment cycle lasts 28
days.

- The following tests and procedures will be performed during specific time points during
the research study: Clinical exams, vital signs, safety blood tests, research blood
tests, electrocardiograms, research urine samples, perfusion CT scans, and assessment
of the tumor(s) by x-ray, CT scans and/or MRI scans.

- Participant's may remain in the research study as long as their cancer is not
progressing and they are tolerating pazopanib.


Inclusion 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

Exclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free rate

Outcome Description:

To determine the progression-free rate in participants with relapsed or refractory small cell lung cancer who have received 1-2 prior regimens of systemic chemotherapy at 8 weeks.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Leena Gandhi, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

10-125

NCT ID:

NCT01253369

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Small Cell Lung Cancer
  • Lung Cancer
  • SCLC
  • pazopanib
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617