Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
Product Name: CP-751,871
Pharmaceutical Form: Solution for injection
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Trade Name: carboplatin
Produ
Sponsors
Pfizer S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically documented NSCLC. 2. NSCLC with documentation of Stage IIIB with a pleural or pericardial effusion or multiple ipsilateral lung nodules, or Stage IV, or recurrent disease 3. For Phase 2 only: Measurable disease defined by at least one lesion that can be accurately measured and whose size is 2 cm by conventional radiologic techniques or 1 cm by spiral CT scan. 4. Adequate bone marrow, hepatic, renal, and cardiac function documented within 14 days prior to enrollment/randomization (see study protocol for further details) 5. Age at least 18 years. 6. ECOG performance status of 0 or 1 (Appendix F) 7. Females must be either: not of childbearing potential (surgically sterilized or at least two years postmenopausal) or if of childbearing potential using an adequate method of contraception, 8. Written and voluntary informed consent. 9. Life expectancy at least 3 months 10. Adequate IV access 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. Any prior treatment for NSCLC including chemotherapy, biologic response modifiers or therapy with any investigational agents including previous adjuvant or neoadjuvant chemotherapy. 2. Inadequate renal, liver or bone marrow function within 14 days prior to enrollment. 3. Gastrointestinal abnormalities including active gastrointestinal bleeding, unrelated to cancer, 4. Symptomatic brain metastases. Brain metastases stable for <2 weeks before dosing or requiring concurrent steroid therapy or with clinical symptoms. 5. A serious uncontrolled medical disorder or active infection, which would impair their ability to receive study treatment. History of HIV(screening test not required). 6. Significant active cardiac disease including: uncontrolled high blood pressure, unstable angina, uncompensated congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac ventricular arrhythmias. 7. Patients who are receiving chronic steroid therapy. 8. Neuropathy greater than grade 1 or evidence of unstable neurological symptoms within the past 4 weeks. 9. Concurrent use of growth hormones or growth hormone inhibitors or aminoglycoside antibiotics. 10. Known or suspected hypersensitivity to agents that contain Cremophor® (polyoxyethylated castor oil) in their formulation or mannitol. Medical contraindications to any of the pre-medications required for paclitaxel infusion. 11. A history of an active malignancy (other than NSCLC) during the last 3 years except non-melanomatous skin cancer or in situ breast or cervical cancer. Breast cancer prevention treatment with hormonal agents will be permitted. 12. Major surgical procedure within 4 weeks of study drug administration. Local radiation within 1 week of study drug administration. 13. Dementia or significantly altered mental status 14. Women who are pregnant or breast-feeding. WOCBP or fertile males not using an adequate method of birth control. (See Inclusion 7).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1b Expansion/escalation: To define the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CP 751,871 when given in combination with paclitaxel and carboplatin. Phase 2: •To assess the efficacy of multiple doses of CP 751,871 in combination with paclitaxel and carboplatin ;Secondary Objective: •To characterize the pharmacokinetics (PK) of CP 751,871 in combination with paclitaxel and carboplatin. •To test for the occurrence of human anti-human antibody (HAHA) response to CP 751,871. •To monitor for any signs of efficacy of CP 751,871 when given in combination with paclitaxel and carboplatin. •To relate systemic exposure of CP 751,871 to safety, efficacy and biomarker endpoints •To assess the safety and tolerability of multiple doses of CP-751,871 in combination with paclitaxel and carboplatin. ;Primary end point(s): Phase 1b: Safety, tolerability, maximum tolerated dose and RP2D Phase 2 Objective Response Rate | — |
Countries
Spain
Outcome results
None listed