Platinum-refractory, locally advanced or metastatic non-small cell lung cancer (NSCLC) MedDRA version: 14.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Sutent
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sunitinib Malate
CAS Number: 341031-54-7
Current Sponsor code: SU011248
Concentration unit: mg milligram(s)
Concentration num
Sponsors
PFIZER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven diagnosis of NSCLC. 2. Disease that is locally advanced (Stage IIIB with malignant effusion), metastatic (Stage IV), or recurrent (after treatment for Stage IIIB with malignant effusion or Stage IV NSCLC). 3. Prior treatment with 1 or 2 chemotherapy regimens including a platinum-based regimen for advanced disease (Stage IIIB with malignant effusion or Stage IV). 4. Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST). 5. Radiographic evidence of disease progression during or following treatment in the advanced disease setting confirmed by the Principal Investigator prior to enrollment in the study. 6. Formalin-fixed, paraffin-embedded tumor tissue available from patients enrolling into the randomized component of this study. (Paired samples collected at the time of the most recent recurrence and at the initial diagnosis are optimal, though samples collected at any time are acceptable). 7. Male or female, 18 years of age or older. Note: Patients enrolled into the lead-in cohort must be /=3.0 g/dL - Absolute neutrophil count (ANC) >/=1500/uL - Platelets >/=100,000/L - Hemoglobin >/=9.0 g/dL - Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior treatment with >2 systemic chemotherapy-based regimens for advanced disease (Stage IIIB with malignant effusion or Stage IV). 2. Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitors, or other angiogenic inhibitors (including but not limited to SU011248, erlotinib, gefitinib, or thalidomide). Note: Patients previously treated with bevacizumab or an IGFR inhibitor will be considered eligible for study entry. Note: Patients previously treated with cetuximab will not be considered eligible for study entry. 3. Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment. At least 7 days should elapse since minor surgical procedure including placement of an access device or fine needle aspiration. 4. Prior high-dose chemotherapy requiring hematopoietic stem cell rescue. 5. Prior radiation therapy to >25% of the bone marrow. 6. Evidence of hemoptysis /=2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 11. Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy). 12. Current treatment with therapeutic doses of coumarin-derivative anticoagulants such as warfarin (however low dose up to 2 mg daily for deep vein thrombosis prophylaxis is allowed during the Phase 2 component of this study but not during the lead-in portion) or anti-vitamin K agents. If currently receiving prophylaxis, PT or INR must be <1.5 times the ULN. 13. Known human immunodeficiency virus (HIV) infection. 14. Current treatment on another therapeutic clinical trial. 15. Pregnancy or breastfeeding. Female patients who are pregnant or nursing, or men and women of reproductive potential who are unwilling or unable to use adequate contraception to prevent pregnancy during the program. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to study entry. 16. Patients with severe dry eye syndrome, Sjogren¿s syndrome, severe exposure keratopathy, bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis, clinically significant gastrointestinal abnormalities including uncontrolled inflammatory disease (e.g. Crohn¿s or ulcerative colitis). 17. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the progression-free survival (PFS) for SU011248 plus erlotinib versus placebo plus erlotinib in patients with platinum-refractory NSCLC.;Secondary Objective: To compare the objective response rate (ORR) for SU011248 plus erlotinib versus placebo plus erlotinib as treatment for platinum-refractory NSCLC. To evaluate measures of duration of tumor control and compare survival. To compare the safety and tolerability of SU011248 plus erlotinib versus placebo plus erlotinib. To evaluate the plasma pharmacokinetics of erlotinib and SU011248 and its active metabolite SU012662 when these drugs are co-administered. To explore the relationships of cancer biomarkers with cancer- and treatment-related outcomes. To compare patient reported outcomes (PRO) including health-related quality of life (HRQOL) and lung cancer-related symptoms in patients treated with SU011248 plus erlotinib versus placebo plus erlotinib.;Primary end point(s): Progression-Free Survival (PFS) | — |
Countries
Hungary, Italy, Spain
Outcome results
None listed