ABOUT THIS STUDY
1. Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
2. Age ≥ 18 years at time of study entry
3. Advanced or metastatic renal cell carcinoma, not amendable to surgery with curative intent, rendering the patient eligible for Tyrosin Kinase Inhibitor (TKI) treatment with sunitinib
4. Intended first-line treatment with sunitinib
5. Documented progressive disease within 6 months prior to study inclusion
6. Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as well as non-measurable disease are eligible.
7. Prior radiotherapy and surgery are allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks) prior to start of treatment and patient recovered from toxic effects.
8. Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
9. Subject is willing to receive additional concomitant coaching and able to comply with the QoL/PRO (patient-reported outcome) assessments specified in the protocol for the duration of the study including scheduled visits, examinations and follow up.
1. Any other anti-cancer treatment aside of sunitinib for mRCC (except palliative
2. Previous malignancy (other than mRCC) which either progresses or requires active
Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a
or T1b prostate carcinoma, or superficial bladder tumor [Ta, Tis and T1].
3. CNS metastases, unless local therapy has been completed for at least 3 month and
patient does not require the use of steroids.
4. Chronic liver disease with Child-Pugh B or C score
5. Female subjects who are pregnant, breast-feeding or male or female patients of
reproductive potential who are not employing an effective method of birth control
(failure rate of less than 1% per year)
6. Any condition that, in the opinion of the investigator, would interfere with
evaluation of the concomitant coaching or QoL assessments or interpretation of patient
safety or study results
7. Participation in another clinical study with an investigational product during the
last 30 days before inclusion
8. Any previous treatment with a tyrosine kinase inhibitor for metastatic disease.
Adjuvant or neoadjuvant therapy for localized disease is permitted, provided that
relapse occurred at least 6 months after last exposure
9. Previous enrollment or randomization in the present study (does not include screening
10. Involvement in the planning and/or conduct of the study (applies to both Pfizer staff
and/or staff of sponsor and study site)
11. Patient who might be affiliated or otherwise dependent on the sponsor, site or the
12. Patient who has been incarcerated or involuntarily institutionalized by court order or
by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].
13. Patients who are unable to consent because they do not understand the nature,
significance and implications of the clinical trial and therefore cannot form a
rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
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