Kidney Cancer Integrated Therapy (KIT) - Personalized integrated therapy for patients with advanced kidney cancer

Phase 1

• Conditions: Personalized integrated therapy for patients with advanced kidney cancer; MedDRA version: 18.0Level: PTClassification code 10050018Term: Renal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004830-25-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-21
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

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

Inclusion Criteria

- Advanced Kidney Cancer (KC) disase at time of diagnosis
- Eligible for nephractomy
- Male and female patients > 18 years
- At least one measurable lesion (>10mm on CT-scan) according to RECIST 1.1
- No prior medically or radiation treatment for their current KC diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance status 1 or lower (See Appendix x)
- No contraindications for PET/CT or mpMRI
- Biochemistry and hematology lab values within normal reference ranges
- Be able to use recommended dose of the selected targeted therapy as described in the drug specific Summary of Product Characteristics (SPC)
- Fertile men and women must be willing to use effective contraceptives as described in section xx to prevent pregnancy
- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.

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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- Metastatic disease from more than one malignancy
- Untreated or symptomatic brain metastasis (patients must be symptom-free without the use of corticosteroids)
- Any reason why, in the opinion of the investigator, the patient should not participate
- Pregnancy and breastfeeding
- Need to use medications contraindicated according to SPC of the different study drugs

Study & Design

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