Relapsed or Refractory Small Cell Lung Cancer MedDRA version: 9.1 Level: LLT Classification code 10041067 Term: Small cell lung cancer
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. 2)Diagnosis of SCLC based on either histology or cytology (by FNA) with radiologically-confirmed progressive disease after first-line chemotherapy. 3) Only one prior chemotherapy regimen. Please refer to protocol for further information. 4) Presence of brain metastases is permitted if subject has completed treatment with surgery and/or radiation more than four weeks prior to date of first dose of study drug and is stable off steroids for at least one week prior to date of first dose of study drug. Subjects who have developed brain metastases following prophylactic cranial irradiation will not be eligible for participation. 5) Age = 18 years 6) Eastern Cooperative Oncology Group (ECOG) performance status of = 2. 7)Ability to swallow and retain oral medication. 8) Disease must be measurable according to RECIST [Therasse, 2000]. 9) Adequate organ system function as defined in the protocol 10) A female is eligible to enter and participate in this study if meets the criteria defined in the protocol. A male with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Prior malignancy 2) History or clinical evidence of central nervous system (CNS) 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. Screening with CNS imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI]) is required . 3) Clinically significant gastrointestinal abnormalities as outlined in the protocol. 4)Presence of uncontrolled infection. 5)Prolongation of corrected QT interval (QTc) >480msecs. 6) 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, as defined by the New York Heart Association (NYHA) (See Appendix 4 for description). 7) Poorly controlled hypertension (defined as systolic blood pressure [SBP] of =140mmHg or diastolic blood pressure [DBP] of = 90mmHg). 8) History of cerebrovascular accident including transient ischaemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 6 months. 9) 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. 10) Evidence of active bleeding or bleeding diathesis. 11) Hemoptysis in excess of 2.5mL within 8 weeks of first dose of study drug. 12) 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. 13) Use of any prohibited medication within the timeframes listed in Section 5.7.2. 14) 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. 15) Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors. 16) Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy). 17) Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity. 18) Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activity of monotherapy pazopanib in terms of the progression-free rate in subjects with relapsed or refractory SCLC, all of whom have received one prior regimen of systemic chemotherapy. Subjects who have relapsed >60 days following completion of initial chemotherapy will be grouped into Cohort A. Subjects who did not respond or who relapsed =60 days following completion of initial chemotherapy will be grouped into Cohort B. Activity will be assessed separately for the two cohorts.;Secondary Objective: To estimate best overall response rate, median overall and progression-free survival, and the modified progression-free rate of subjects in each of the two cohorts ;To characterize the toxicity profile of pazopanib in each of the two cohorts; To identify and measure urinary matrix metalloproteinase (MMP) levels and to assess the usefulness of these enzymes as surrogate markers of angiogenesis inhibition. Urinary MMP’s will also be assessed as potential early markers for progression.;Primary end point(s): Progression-free rate as determined by radiological assessment using standard Response Evaluation Criteria in Solid Tumors (RECIST) at Week 12 for subjects in Cohort A and at Week 8 for subjects in Cohort B. | — |
Countries
Denmark
Outcome results
None listed