Study of Debio 0932 in Patients With Advanced Solid Tumours or Lymphoma

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the maximum tolerated dose of Debio 0932 when administered orally, every-other-day or daily during the first 30 days, in patients with solid tumours or lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiopharm International SA

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of advanced solid tumours or lymphoma, except for primitive hepatocarcinoma for which radiological diagnosis only is permitted;

• Advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication or have refused standard therapy,

• Measurable and/or evaluable disease,

• Age ≥ 18 years,

• ECOG performance ≤ 1

• Life expectancy ≥ 3 months,

• If female, neither pregnant or lactating,

• Negative pregnancy test for females at screening, preferably done within 1 week before Day 1 of treatment (not applicable to patients with bilateral oophorectomy and/or hysterectomy),

• Agreeing to use appropriate medically approved contraception (physical barrier contraception is recommended) from study entry to 6 months after the last day of treatment for the patient,

• Absolute neutrophil count ≥ 1,500/µL; platelets ≥ 100,000/µL; calculated creatinine clearance ≥ 60mL/min (calculated according to the formula of Cockroft and Gault); total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2.5x ULN. In patients with documented liver metastases, the AST/ALT may be ≤ 3.5x ULN; prothrombin time ≤1.5x ULN, kalemia, magnesemia and phosphatemia > LLN (Lower Limit of Normal)

• Able to render informed consent and to follow protocol requirements,

• Able to swallow capsules,

• Able to comply with scheduled plans, laboratory tests, and other study procedures.

Exclusion Criteria:

• Received investigational agents or systemic anti-cancer agents within 14 days of Day 1 of treatment, or 28 days for those agents with unknown elimination half-lives, or known elimination half-lives greater than 50 hours; or 6 weeks for Mitomycine C or for nitrosourea agents,

• Unresolved toxicity from previous treatment or previous investigational agents,

• Patients with history of prior radiation that potentially included the heart in the field (e.g. mantle),

• Cardiac exclusion criteria:

• History of significant coronary artery disease or congestive heart failure that meets NYHA class III or IV, within 12 months (see Appendix D),

• Significant cardiovascular dysfunction : pulmonary hypertension, right ventricular systolic dysfunction, aortic stenosis, mitral insufficiency > grade 2 and/or Left Ventricular Ejection fraction < 45% or < 55% if prior exposure to anthracyclines, based on MUGA or echocardiography,

• Uncontrolled hypertension (Systolic > 150 or diastolic >100),

• Permanent and uncontrolled cardiac rhythm disorders and clinical relevant abnormalities in 12-lead ECG/Holter, such as WPW (Wolff-Parkinson-White) syndrome, QRS > 120 msec, PR > 220 msec, heart rate < 50 bpm, Q wave, ST deviation, left bundle branch block, atrial fibrillation, flutter, tachysystoly.

• Prolonged QTc interval > 450 msec in men and > 470 msec in women using Fridericia formula,

• Congenital long QT syndrome,

• Use of any medication associated with known QTc interval prolongation (a non-exhaustive list will be provided separately)

• Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C,

• Patients with uncontrolled brain metastases,

• Gastrointestinal diseases or disorders that could affect drug absorption such as diarrhoea, major abdominal surgery, significant bowel obstruction and/or gastrointestinal diseases that could alter the assessment of safety, including any of the following:

• Irritable bowel syndrome

• Ulcerative colitis

• Crohn disease

• Haemorrhagic coloproctitis

• Concurrent participation with any other anticancer therapy.