Status:
COMPLETED
Study of Debio 0932 in Patients With Advanced Solid Tumours or Lymphoma
Lead Sponsor:
Debiopharm International SA
Conditions:
Cancer
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 lympho...
Detailed Description
This is an open-label, non-randomised, dose-escalation phase I, pharmacokinetic and pharmacodynamic study in patients with advanced and/or refractory malignancies (solid tumours or lymphoma), to deter...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01168752
Start Date
April 1 2010
End Date
April 1 2013
Last Update
February 3 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Georges-François Leclerc
Dijon, France, 21079
2
Institut Claudius Regaud
Toulouse, France, 31052
3
Institut Gustave Roussy
Villejuif, France, 94805