Use of Individual Pharmacokinetically (PK)-Guided Sunitinib Dosing: A Feasibility Study in Patients With Advanced Solid Tumors

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this prospective study is to determine the safety and feasibility of pharmacokinetically (PK) guided dosing of sunitinib in 30 patients.

At day 15 ± 1day, day 29 ± 1day and after 8 weeks ± 1day of sunitinib treatment sunitinib and SU12662 trough levels will be measured. Depending on the sunitinib and SU12662 trough levels (and toxicity) dose adjustments will be made.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborator: Pfizer
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

1. Histopathologically confirmed advanced tumors for which sunitinib is considered standard or patients with advanced or metastatic tumors for whom no standard therapy is available;

2. Age more then 18 years;

3. Able and willing to give written informed consent;

4. Able and willing to undergo blood sampling for pharmacogenetic and pharmacokinetic analysis;

5. Able and willing to undergo a tumor biopsy for DNA sequencing;

6. Able to swallow oral medications

7. Life expectancy more then 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;

8. WHO performance status of 0 or 1;

9. Evaluable disease according to RECIST 1.1 criteria;

10. Minimal acceptable safety laboratory values

• ANC of => 1.5 x 109 /L

• Platelet count of => 100 x 109 /L

• Hepatic function as defined by serum bilirubin => 1.5 x ULN, ASAT and ALAT

• 2.5 x ULN

• Renal function as defined by serum creatinine => 1.5 x ULN or creatinine clearance => 50 mL/min (by Cockcroft-Gault formula);

11. No radio- or chemotherapy or other investigational drug treatment within the last 4 weeks prior to study entry, with the exception of palliative radiotherapy (8 Gy or on the extremities).

Exclusion Criteria:

1. Current treatment in another therapeutic clinical trial

2. Congestive heart failure, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina or any unstable arrhythmia requiring medication

3. Patients with known alcoholism, drug addiction and/or psychotic disorders in the history that are not suitable for adequate follow up

4. Women who are pregnant or breast feeding.

5. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (definition of adequate contraceptive methods will be based on the judgment of the principal investigator or a designated associate).

6. Legal incapacity

7. Known allergy/intolerance to sunitinib or any of the excipients