Advanced Solid Tumors, Excluding Breast Cancer
Conditions
Keywords
cancer, tumors, phase I, crossover, bioequivalence
Brief summary
This is a multi-center, open-label, two way crossover study designed to test the bioequivalence of 2 different oral forms of TKI258, FMI capsule and FMI tablet in patients with advanced solid tumors, excluding breast cancer. The aim of this test is to demonstrate that those 2 formulations are considered to be the same for all intents and purposes by making sure they are acting on the body with the same strength and are absorbed in similar amounts by the body. During the bioequivalence phase, patients will take orally at a daily dose of 500 mg one formulation of TKI258 during the first 3 weeks of treatment on a 5 days on/2days off dosing schedule, after which time, patients will switch to the alternate formulation for one additional week. After the bioequivalence phase, all patients may continue to take orally at a daily dose of 500 mg only TKI258 FMI capsule formulation until disease progression (assessed by RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any other reason.
Interventions
DRUGTKI258
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a histopathologically or cytopathologically confirmed diagnosis of an advanced solid tumor, excluding breast cancer, who have progressed despite standard therapy, or for which no standard therapy exists 2. ECOG performance status (PS) 0, 1 or 2 3. Patients must meet protocol-specified laboratory values
Exclusion criteria
1. Patients with brain metastases 2. Patients who have concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study 3. Patients who have not recovered from previous anti-cancer therapies 4. Patients who are expected to receive any prohibited medications during the bioequivalence phase of the study 5. Female patients who are pregnant, breast feeding 6. Fertile male or women of child-bearing potential not willing to use two highly effective methods of contraception Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of Pharmacokinetics of TKI258, FMI capsule (supplied in 100 mg strength) and FMI tablet (supplied in 250 mg strength), in patients with advanced solid tumors, excluding breast cancer based on PK parameters AUClast and Cmax | 9 days |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of Adverse Events in patients treated with TKI258 on a 5 days on/2 days off dosing schedule in patients with advanced solid tumors, excluding breast cancer | up to 30 days after the last dose of study drug |
| Preliminary evidence of anti-tumor activity based on RECIST criteria of TKI258 in patients with advanced solid tumors, excluding breast cancer | Every 8 weeks until progression of disease |
Countries
United States
Outcome results
None listed