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Phase 1

• Conditions: Metastatic collecting duct carcinoma; MedDRA version: 17.1 Level: LLT Classification code 10073252 Term: Carcinoma of the collecting ducts of Bellini System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2013-001179-19-FR
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-06
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 41

Inclusion Criteria

1-Patients with histologically confirmed metastatic collecting duct carcinoma,
2-Available tumor samples for centralized reading by anatomopathologist,
3-Patients with or without nephrectomy,
4-At least one measurable lesion as per RECIST criteria (RECIST v1.1),
5-No prior chemotherapy nor anti-angiogenic drugs (naive patients),
6- No irradiation within 4 weeks before inclusion,
7-Absolute neutrophil counts (ANC) = 1.5 x 10^9/L,
8- Platelets =100 x 10^9/L,
9- Hemoglobin =9 g/dL,
10- Hepatic function : AST and ALT = 1.5 x ULN (= 4 x ULN in case of liver metastases); total bilirubin = 1.5 x ULN; alkaline phosphatase < 2 x ULN (= 4 x ULN in case of bone metastases),
11- Renal function : creatinine clearance = 60 mL/min (MDRD calculation method),
12- Absence of proteinuria at baseline defined by < 0.3 g of protein on urine sample or < 0.5g/24h00 on urine collection,
13- Prothrombin time (TP) or partial thromboplastin time (PTT) less than 50% deviation from normal limits, of international normalized ratio (INR) below 2,
Note: The use of full-dose oral or parenteral anticoagulants as well as aspirin or clopidogrel is permitted as long as the INR or a PTT is within therapeutic limits (according to the medical standard of the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of study enrollment. Prophylactic use of anticoagulants is allowed.
14- ECG with normal sinus rhythm and no clinically significant changes,
15- Patients should be aged = 18 years at the inclusion,
16- ECOG Performance Status: 0 – 2,
17- Estimated life expectancy = 12 weeks,
18- Patients who have received the information sheet, dated and signed the informed consent form,
19- Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 4 months after the last study treatment intake for women and 6 months for men.
20- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory
tests and other study procedures,
21- Patients affiliated to the Social Security System,
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

1. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment,
2. Prior systemic treatment with chemotherapy or anti-angiogenic tyrosine kinase inhibitors such as axitinib, sunitinib, sorafenib, pazopanib, tivozanib, mTOR inhibitor (Temsirolimus or everolimus) and targeted VEGF drugs such as bevacizumab and VEGF trap,
3. Evidence of current central nervous system (CNS) metastases or spinal cord compression. If CNS metastases are suspected, patient should undergo an MRI or CT-Scan of the brain (with contrast, if possible) within 28 days prior to inclusion,
4. Another histological type of renal cancer
5. Other malignancy within 3 years prior to inclusion (except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, and/or pT1/a bladder cancer),
6. Uncontrolled hypertension (=160 mm Hg systolic and/or = 90 mm Hg diastolic) while receiving medication,
7. Cardio-vascular disorders: congestive heart failure = NYHA II, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina,
8. LVEF value less than 50%,
9. Current or recent (within 2 weeks of study enrolment) initiation of aspirin, clopidogrel), oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes.
10. History of clinically significant hemorrhagic of thromboembolic events in the past six months, or known inherited predisposition to bleeding or thrombosis or History of abdominal fistula, GI
perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment; History of haemoptysis = grade 2 (defined as = 2.5 mL bright red blood per episode) within 1 month of study enrolment,
11. Patients who underwent, according to the investigator, a significant surgery such as but not limited to , abdominal, thoracic or neurologic surgery within 28 days before the first treatment
administration or patient with a wound that is not already healed at the first treatment administration or patients who underwent a minor surgical procedure including placement of a vascular access device, within 2 days of the first study treatment,
12. Patients with active ulcer,
13. Patients with untreated bone fracture,
14. Peripheral neuropathy grade = 2 (Toxicity Criteria-(CTCAE) v4.0),
15. Including patients with active infection requiring intravenous antibiotics at the time of first study treatment,
16. In the opinion of the investigator, any evidence of other severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or any other acute or chronic medical condition that would make the patient inappropriate with this study,
17. Immunocompromised patients, including known seropositivity for human immunodeficiency virus (HIV),
18. Known hypersensitivity to any component of the investigational drugs or excipients,
19. Pregnant or lactating women,
20. Person deprived of their liberty or under judicial protection (including guardianship),
21. Patients with significantly altere

Study & Design

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