Optimisation of Pazopanib Exposition in Patients with Renal Cell Carcinoma by Therapeutic Drug Monitoring followed by Individual Dose Escalatio

• Conditions: Renal cell carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002962-11-DE
• Lead Sponsor: Interessenverband zur Qualitätsicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland (IQUO) e.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-05
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Clinically suspected and known metastases of the central nervous system or meningeosis carcinomatosis 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, colitis ulcerosa) 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified