Optimizing Pazopanib Exposure in RCC Patients

• Status: Terminated
• Trial end date: 2016-03-22
• Target enrollment: 0
• Participant gender: All

Summary

Optimization of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic Drug Monitoring followed by Individual Dose Escalation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Interessenverband zur Qualitätssicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland e.
• Collaborator: OnkoDataMed GmbH

Criteria

Inclusion Criteria:

• signature of informed consent

• age ≥ 18 years

• histologically confirmed renal cell carcinoma with clear cell component and either locally progressed or metastasized

• ECOG ≤ 2

• No previous systemic therapy for locally progressed or metastasized renal cell carcinoma (previous adjuvant or neo-adjuvant therapy is permitted)

• Adequate organ function

• Female patients with child-bearing potential with negative serum pregnancy test within 2 weeks prior to first dose of study medication and adequate contraception

• Lactating females

Exclusion Criteria:

• Clinically suspected and known metastases of the central nervous system or carcinomatous meningitis except in asymptomatic patients with previously treated CNS-metastases and no necessity of steroids or anti-epileptic medication ≥ 6 months prior to start of the study medication

• Clinically significant gastrointestinal conditions with risk of increase of gastrointestinal bleeding due to (but not limited to)

• active peptic ulceration

• known intraluminal metastases with risk of bleeding

• chronic-inflammatory intestinal disease (like Morbus Crohn, ulcerative colitis) or another gastrointestinal disease with increased risk of perforation

• abdominal fistulas in anamnesis

• Clinically significant gastrointestinal conditions which can influence absorption of the IMP, among others (but not limited to)

• malabsorption syndrome

• resection of stomach or small bowel

• Current uncontrolled infection

• QTc corrected for heart frequency according to the Bazett formula

• One or more of the following cardiovascular diseases within the last 6 months in the anamnesis:

• cardiac angioplasty or coronary stent implantation

• myocardial infarction

• instable angina pectoris

• coronary-arterial bypass surgery

• symptomatic peripheral arterial occlusive disease

• Heart failure NYHA III or IV

• Poorly controlled high blood pressure

• Cerebrovascular disease, including transitory ischemic attacks, pulmonary artery embolism or untreated deep vein thrombosis within 6 months of study inclusion

• Previous major surgery or traumas within 28 days prior to start if study treatment or non-healing wound, fracture or ulcer

• Clinical signs of active bleeding or bleeding diathesis

• Known endobronchial lesions or lesions infiltrating the large lung arteries

• Haemoptyses of > 2.5 mL within 8 weeks prior to first intake of study medication

• Any other severe and/or instable medical or psychiatric pre-existing or other condition influencing patient safety, consent capacity or compliance within the study

• Incapacity or rejection to stop not allowed medication prior to first intake of study drug and pause for the duration of the trial

• Treatment with one of the following anti-tumour therapies:

• Radiation or tumour embolism within 14 days before first intake of study drug

• Chemotherapy, Immunotherapy, biological therapy, study medication or hormonal therapy within 14 days or 5 half-lives of the respective substance (whichever is longer) before first intake of the study drug. Neo-adjuvant or adjuvant therapy must have been completed for at least 6 months.

• Any present toxicity > CTC 1° from prior anti-tumour therapy and/or toxicities worsening in severity except alopecia