An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Docetaxel; Paclitaxel; Vadimezan

Criteria

Inclusion Criteria:

• Patients having histologically-proven solid tumors, who are either refractory to standard chemotherapy

• Patients whom chemotherapy with an investigaional agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate

• Creatinine clearance according to Cockcroft-Gault formula : Normal > 80 mL/min, Mild 50-80 mL/min, Moderate 30-<50 mL/min

• A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies

• Potassium, calcium, magnesium and phosphorus values within the normal range

• Body Mass Index (BMI) must be within the range of 18 and 30

Exclusion Criteria:

• Patients having CNS metastases, must have a CT or MRI of the brain performed to rule out CNS metastases

• Patients with leptomeningeal disease metastases

• Radiotherapy
• Major surgery
• Administration of CYP1A2 and CYP3A4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug

Other protocol-defined inclusion/exclusion criteria may apply