Sunitinib rechallenge in metastatic kidney cancer

PHASE II STUDY OF SUNITINIB AS RECHALLENGE THIRD-LINE THERAPY IN METASTATIC RENAL CANCER

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000473-23-IT

Enrollment

Unknown

Registered

2012-03-07

Start date

2012-05-29

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

Metastatic renal cancer thrid-line therapy already treated in fist-line therapy with Sunitinib. MedDRA version: 14.1 Level: LLT Classification code 10009251 Term: Clear cell carcinoma of the kidney System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: SUTENT*30CPS 50MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: SUNITINIB CAS Number: 557795-19-4 Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven diagnosis of Renal Cell Carcinoma with predominant clear cell component. 2. First-line treatment with Sunitinib. 3. Patients with a Disease Control Rate (Complete Response + Partial Response + Stable Disease) lasting at least 10 months from first-line Sunitinib treatment. 4. Second-line treatment with Everolimus. 5. Age higher than 18. 6. ECOG Performance Status 0-2. 7. Life expectancy of at least 8 weeks. 8. Measurable lesions according to RECIST criteria. 9. Adequate cardiac, hepatic, renal, and bone marrow function. 10. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 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 5

Exclusion criteria

Exclusion criteria: 1. First-line treatment with other compounds (excluding Sunitinib). 2. Symptomatic and/or unstable and/or not previously treated pre-existing brain metastases. 3. Uncontrolled hypertension. 4. Severe or uncontrolled cardiovascular diseases within 6 months of study. 5. Active uncontrolled infections. 6. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the antitumor activity of Sunitinib in terms of freedom from disease progression.;Secondary Objective: 1)To evaluate Sunitinib activity in terms of objective response rate 2) To evaluate the efficacy in terms of progression free survival (PFS) and overall survival (OS) 3) To evaluate the tolerability of Sunitinib.;Primary end point(s): Freedom from disease progression.;Timepoint(s) of evaluation of this end point: 6 months.	—

Measure

Time frame

Main Objective: To assess the antitumor activity of Sunitinib in terms of freedom from disease progression.;Secondary Objective: 1)To evaluate Sunitinib activity in terms of objective response rate 2) To evaluate the efficacy in terms of progression free survival (PFS) and overall survival (OS) 3) To evaluate the tolerability of Sunitinib.;Primary end point(s): Freedom from disease progression.;Timepoint(s) of evaluation of this end point: 6 months.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Objective response rate (CR + PR) 2) PFS and OS 3) Toxicity;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Italy

Contacts

Public ContactS.C. Oncologia medica

Fondazione IRCCS Policlinico San Matteo

c.porta@smatteo.pv.it0382 502581

Outcome results

None listed

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