Health Condition 1: null- Advanced Solid Tumours Health Condition 2: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: Oral Paclitaxel: Oral Paclitaxel liquid Each 1 ml liquid of contains 50mg Paclitaxel (50 mg/ml)
Control Intervention1: None: None
Sponsors
Cadila Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: • 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 = 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/dL
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage I: â?¢ Determination of maximum tolerated dose (MTD) by evaluating safety and tolerability of single dose â?¢ Assessment of pharmacokinetic profile of single dose. Stage II: â?¢ Establishing the dose and its schedule based on safety and tolerability profile. 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Akhil Sanghal
Cadila Pharmaceuticals Limited
Outcome results
None listed