Study of new oral drug in cancer patients with advance solid tumour.
- Conditions
- Health Condition 1: null- Advanced Solid TumoursHealth Condition 2: C801- Malignant (primary) neoplasm, unspecified
- Registration Number
- CTRI/2016/02/006607
- Lead Sponsor
- Cadila Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
•Male/Female Patients of 18-65 years of age with histologically/ cytologically diagnosed to have an advanced solid tumor except Gastrointestinal Cancer.
•Patients should have progressed after at least two lines of chemotherapy and standard of care is not available.
•Patients will be eligible after 4 weeks of final treatment (Chemotherapy and/or radiation and/or surgery) or 6 weeks of Nitrosoureas or Mitomycin C Treatment. Patient should have fully recovered from related toxicities
•ECOG performance status <= 2 and Life expectancy >= 24 weeks
•Patients have proper bone marrow, kidney, liver, heart and lung function without clinical significant laboratory parameters: Platelet >= 100,000/mm3; Hb>=9.0g/dL; ANC>=1,500/mm3; Creatinine <= 1.5mg/dL; AST/ALT/ALP<=3X the upper limit of normal; Total bilirubin <= 2.0mg/d
•Patients with bone marrow/hemato-malignancies, myloid malignacies, uncontrolled infectious disease, neurologic disorders, metastasis to CNS, ileus (patients requiring non-oral administration of antibiotics to treat active bacterial infection, however such patients can participate in the trial after complete eradication or control of the infection)
•Patients who have received bone marrow transplant or are planning to receive bone marrow transplant
•Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months
•Bowel obstruction or motility disorders that could influence the absorption of drugs.
•Patients who are on PGP inhibitor such as Cyclosporine or Verapamil. Such patients may qualify after Four-week wash-out period
•Chronic use of H2 receptor antagonist or Proton pump inhibitor
•Pregnant or lactating or with childbearing potential without use of adequate contraception (in case of men, appropriate contraception is required
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stage I: <br/ ><br>â?¢Determination of maximum tolerated dose (MTD) by evaluating safety and tolerability of single dose <br/ ><br>â?¢Assessment of pharmacokinetic profile of single dose. <br/ ><br>Stage II: <br/ ><br>â?¢Establishing the dose and its schedule based on safety and tolerability profile. <br/ ><br>Timepoint: 0.00, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 8.00, 12.00, 24.00, 36.00, 48.00
- Secondary Outcome Measures
Name Time Method Assessment of pharmacokinetic profile of single dose.Timepoint: 0.00, 0.50, 0.75, 1.00, 1.25, 1.50, 2.00, 3.00, 4.00, 8.00, 12.00, 24.00, 36.00, 48.00