patients with advanced solid tumors MedDRA version: 18.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: F17752
Product Code: F17752
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: F17752
Current Sponsor code: F17752
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase I Histologically or cytologically confirmed advanced solid tumour. Patients with solid tumours known to present with Alk, ROS or Trk rearrangement will be preferentially recruited Refractory to available therapies or for whom no standard of care therapy is available Phase II Cohort 1: NSCLC patients whose tumours exhibit Alk or ROS rearrangement and who are resistant to at least one prior Alk inhibitor, or other actionable targets pertinent to F17752 activity, Cohort 2: patients with colon cancer whose tumours exhibit Trk rearrangement, or other actionable targets pertinent to F17752 activity. Criteria common to phase I and phase II parts 1. Tumour tissue available for analysis. If sufficient tissue is not available, patients must undergo a biopsy to obtain adequate samples. In cohort 1 for which failure to prior Alk inhibitor is required, tumour tissue must be obtained following failure to prior therapy, 2. Measurable disease according to RECIST (version 1.1), 3. Female or male, 18 years of age or older, 4. WHO performance status or=12 weeks, 6. Adequate haematological function defined as ANC > or= 1.5 x 109/L, platelet count > or= 100 x 109/L and haemoglobin > or= 9 g/dL, 7. Adequate liver function tests defined as total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 122
Exclusion criteria
Exclusion criteria: for Phase I and Phase II 1. Major surgery, radiotherapy or systemic anti-cancer therapy within 3 weeks of starting study treatment ; only for systemic anticancer therapy, within 2 weeks in cohort 1, 2. Patients central nervous system metastases unless the patient has completed local therapy, is stable for at least 4 weeks on CT-scan without evidence of cerebral oedema and has no requirement for corticosteroids or anticonvulsivants, 3. Current active infection; any concurrent, uncontrolled medical disorder, making implementation of the protocol difficult, 4. Known HIV infection, 5. History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix, and surgically-treated-only or lobular carcinoma in situ of the breast diagnosed more than 5 years ago, 6. Active heart disease including myocardial infarction within the previous 6 months, symptomatic coronary artery disease, arrhythmia not controlled by medication or uncontrolled congestive heart failure, 7. Known malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of F17752, 8. Concurrent treatment with any other anti-cancer therapy, 9. Participation in another trial of an investigational agent within 30 days before study entry and during the study, 10. Known hypersensitivity to drugs with similar chemical structures, 11. Congenital lactose intolerance, 12. Pregnant or lactating women, women with positive pregnancy test at inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: to determine the maximal tolerated dose (MTD) of F17752 administered orally once a day for 2 weeks followed by one week rest every 3 weeks in patients with advanced solid tumors Phase II: to evaluate the efficacy of the F17752 in 2 histologically and molecularly defined cohorts of patients in terms of response rate (NSCLC and colon cancer);Secondary Objective: Phase I: to determine the recommended dose (RD) of F17752 to be used in the Phase II to assess the safety of F17752 to assess the antitumor activity of F17752 to assess the pharmacokinetics of F17752 including preliminary investigation of the food effect Phase II to extand the evaluation of safety at the RD to assess the progression free survival and the overall survival to asses the the pharmacokinetics of F17752 at the RD;Primary end point(s): Phase I: to determine the maximal tolerated dose (MTD) of F17752 administered orally once a day for 2 weeks followed by one week rest every 3 weeks in patients with advanced solid tumors Phase II: to evaluate the efficacy of the F17752 in 2 histologically and molecularly defined cohorts of patients in terms of response rate (NSCLC and colon cancer);Timepoint(s) of evaluation of this end point: Phase I dose escalation will be stopped once the MTD is reached. the recommended dose will be the dose immediately below the MTD or and intermediate dose level (20% increment below the MTD) Phase II end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase I: to determine the recommended dose (RD) of F17752 to be used in the Phase II to assess the safety of F17752 to assess the antitumor activity of F17752 to assess the pharmacokinetics of F17752 including preliminary investigation of the food effect Phase II to extand the evaluation of safety at the RD to assess the progression free survival and the overall survival to asses the the pharmacokinetics of F17752 at the RD;Timepoint(s) of evaluation of this end point: Phase I end of the Phase I study, last patient last visit, 30 days after the last study drug administration Phase II end of the study, date of the last progression of the treated patients | — |
Countries
France, Italy, Poland, Spain
Contacts
Public ContactCLINICAL STUDY MANAGER
PIERRE FABRE MEDICAMENT
Outcome results
None listed