Cabo-POLARIS : A Trial to Evaluate Cabozantinib Among Haemodialysied Patients

Main Inclusion Criteria:

• Documented histological diagnosis of advanced or metastatic renal cell cancer with a clear-cell or papillary component.
• Must have received at least one prior line of systemic therapy.
• Undergoing haemodialysis for more than 3 months without major complications that might confound the results of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
• Recovery to baseline or ≤ Grade 1 CTCAE v.4.0 from toxicities related to any prior treatments, unless AE(s) are considered clinically nonsignificant by the investigator and/or stable on supportive therapy.
• Age eighteen years or older on the day of consent.
• Karnofsky Performance Status (KPS) score of ≥ 70%.
• Adequate organ and marrow function.

Main exclusion Criteria:

• Prior treatment with cabozantinib.
• Kidney cancer without clear-cell or papillary component.
• Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before cabozantinib initiation.
• Receipt of any type of anticancer antibody within 2 weeks before randomization. For investigational antibody the delay is 4 weeks.

5 Major surgery within 4 weeks or major radiotherapy within 2 weeks prior to starting cabozantinib. Previous palliative radiotherapy (≤ 10 fractions) for metastatic lesions is permitted, provided that this has been completed at least 48 hours prior to starting cabozantinib. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.

• Known brain metastases or spinal compression unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 6 weeks before randomization. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of randomization. Patients with a past history of meningeal carcinomatosis are not eligible.

• The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

7a. Cardiovascular disorders

7b Active infection requiring systemic treatment.

7c. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation

7d. Clinically significant haematuria, hematemesis, or haemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary haemorrhage) within 3 months before randomization.

7e. Cavitating pulmonary lesion(s) or known endobronchial disease manifestation.

7f. Lesions invading major pulmonary blood vessels. 7g. Other clinically significant disorders.

• Corrected QT interval > 480 msec within 1 month before randomization. Three ECGs must be performed. If the average of these three consecutive results for QTcF is ≤ 480 msec, the subject meets eligibility in this regard.

• - Existence of a past history of cancer within 3 years prior to inclusion into the study (excluding cured localized cancer such as non-melanomatous skin cancers, superficial bladder cancers, or in situ for breast or uterine cervical cancer, and localized prostate cancer without biochemical PSA relapse).