NSCLC
Conditions
Interventions
Trade Name: Torisel
Product Code: Torisel
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Temsirolimus
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration numbe
Sponsors
MUW, Klinik für Innere Medizin I, Onkologie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed stage IIIB or IV NSCLC. • Measurable disease according to RECIST Criteria 1.1 11 • Relapsed or progressed after treatment with 1 or 2 (no more than 2) prior chemotherapy regimens (with or without bevacizumab), at least 1 of which must have been a platinum-based treatment. Patients may not have received investigational therapy as their only prior therapy. • Recovered from the toxic effects of prior therapy. • Eastern Cooperative Oncology Group (ECOG) performance status 0-2. • At least 18 years of age. • Adequate hematologic function as defined by: white blood cell (WBC) count = 2500 cells/µL; absolute neutrophil count (ANC) = 1500 cells/µL; platelet count = 100,000/µL; adequate hepatic, and renal function within 7 days prior to randomisation as defined by serum creatinine 12 months since last menses) or are surgically sterilized do not require this test. • Men who are not surgically sterile must be practicing a medically safe and effective contraceptive regimen from the time of study inclusion, and agree to continue practicing until at least 90 days after the last administration of study treatment. • Accessible for repeat dosing and follow-up. • Life expectancy of greater than 12 weeks. • Given written informed consent (IC). 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: • Active concurrent primary malignancy (except non-melanoma skin cancer or in situ carcinoma of the cervix). If there is a history of prior malignancy, the patient must be disease-free for at least 5 years. • Use of any investigational drugs, biologics, or devices within 4 weeks prior to inclusion. • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to inclusion. • Previous exposure to temsirolimus or erlotinib (or other TKIs). • Women who are pregnant or breastfeeding. • Not recovered from uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia. • Uncontrolled hypertension. • Known HIV-positive status. • Treatment with vitamin K antagonists • Active smokers (currently smoking more than one cigarette per day for at least one year)* • Concomitant treatment with strong CYP3A4 inhibitors or inducers • Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. • Patients with known hypersensitivity reactions to Torisel® or Tarceva® • Patients with known hypersensitivity reactions to macrolide antibiotics (such as erythromycin, clarithromycin and azithromycin) * as smoking is known to reduce exposure to erlotinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to recommend a dose for the subsequent main phase (define the MTD) and to evaluate the safety and tolerability of every-week administration of temsirolimus 25 (15) mg in combination with continuous administration of erlotinib 150 (100) mg daily) in patients with stage IIIB/IV non-small cell lung cancer (NSCLC) after failure of at least one platinum-based chemotherapy regimen.;Secondary Objective: To determine anti-tumor activity of the drug combination by assessing response;Primary end point(s): The design will be a 2 out of 6 dose escalation/reduction design. Initiation of the next dose level will be agreed by the DSMB according to the safety data available. Furthermore, the occurrence of events meeting the definition of DLT will be checked. Toxicity is graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0. The MTD is defined as the highest dose level at which no more than three patients experienced a DLT, when at least 12 patients were treated at that dose and were evaluable for toxicity. Descriptive analyses will be used. | — |
Countries
Austria
Outcome results
None listed