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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004830-25-NO

Enrollment

Unknown

Registered

2015-05-21

Start date

2015-09-01

Completion date

Unknown

Last updated

2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Personalized integrated therapy for patients with advanced kidney cancer MedDRA version: 18.0 Level: PT Classification code 10050018 Term: Renal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Cometriq (Kabozantinib) Product Name: Cometriq Pharmaceutical Form: Capsule Trade Name: Afinitor (Everolimus) Product Name: Afinitor Pharmaceutical Form: Tablet Trade Name: Torisel (Tems

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The proposed interdisciplinary translational project will assist in the decision-making process for individualizing patient treatment. With our integrated approach we want to assess the feasibility of using molecular profiling, MP (gene expression in normal and tumor DNA) of a patients’ tumor to find actionable driver mutations for their resistant renal cell cancer, and optimize the therapeutic decision process by identifying the dominating metastatic structure, and using this method in 2nd line treatment to find the right personalized treatment for patients with resistant renal cell cancer.;Secondary Objective: • To explore and compare the original genotype findings and the potential mechanism of treatment resistance • Assessment of tumor glucose metabolism • To evaluate health-related quality of life changes from baseline ;Primary end point(s): To determine this objective we will compare treatment response for personalized therapy based on a patient’s tumor (Treatment Period 2, TP2) with the treatment response for the most recent therapy on which the patient experienced progression (Treatment Period 1, TP1) (N-of-1 design). We hypothesize that patients will have an increased PFS at the end of second line treatment compared to the first line treatment. If the PFS of TP2 / PFS of TP1 ratio is = 1.3, the therapy selected based on the molecular profiling is defined as having benefit for the patient ;Timepoint(s) of evaluation of this end point: Screening, week 12 and thereafter every 6th months.	—

Measure

Time frame

Main Objective: The proposed interdisciplinary translational project will assist in the decision-making process for individualizing patient treatment. With our integrated approach we want to assess the feasibility of using molecular profiling, MP (gene expression in normal and tumor DNA) of a patients’ tumor to find actionable driver mutations for their resistant renal cell cancer, and optimize the therapeutic decision process by identifying the dominating metastatic structure, and using this method in 2nd line treatment to find the right personalized treatment for patients with resistant renal cell cancer.;Secondary Objective: • To explore and compare the original genotype findings and the potential mechanism of treatment resistance • Assessment of tumor glucose metabolism • To evaluate health-related quality of life changes from baseline ;Primary end point(s): To determine this objective we will compare treatment response for personalized therapy based on a patient’s tumor (Treatment Period 2, TP2) with the treatment response for the most recent therapy on which the patient experienced progression (Treatment Period 1, TP1) (N-of-1 design). We hypothesize that patients will have an increased PFS at the end of second line treatment compared to the first line treatment. If the PFS of TP2 / PFS of TP1 ratio is = 1.3, the therapy selected based on the molecular profiling is defined as having benefit for the patient ;Timepoint(s) of evaluation of this end point: Screening, week 12 and thereafter every 6th months.

—

Secondary

Measure	Time frame
Secondary end point(s): - Gene alteration/expression status in tumor tissue and ctDNA - SUVs (standardized uptake value) acquired from FDG-PET/CT ;Timepoint(s) of evaluation of this end point: Screening, week 12 and thereafter every 6th months.	—

Countries

Norway

Contacts

Public ContactWolfgang Lilleby

Oslo University Hospital

WLL@ous-hf.no4722934000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026