PHASE I-II STUDY OF F17752 IN PATIENTS WITH ADVANCED SOLID TUMOURS

Phase 1

• Conditions: patients with advanced solid tumors; MedDRA version: 18.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003009-24-FR
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-16
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 122

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 5. Anticipated life expectancy > 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 8. Adequate renal function defined as serum creatinine 9. Normal QT interval on electrocardiogram performed at baseline
10.Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimized. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment,
11. Fertile men must be using an effective method of birth control throughout the study period and up to 3 months after the last dose of study drug if their partners are women of childbearing potential,
12. The patient must have access to social insurance if applicable in the local regulations,
13. Informed written consent,
14. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

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 122
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified