Pharmacokinetic analysis of docetaxel and dexamethasone in combination with aprepitant in Japanese patients with solid tumors.

Not Applicable

Recruiting

• Conditions: cancer

• Registration Number: JPRN-UMIN000007629
• Lead Sponsor: Saitama Medical University, International Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients with contraindication to docetaxel, involved with bone marrow suppression, active infection, severe hypersensitivity to ingredients contained by docetaxel. 2. Patients with contraindication to aprepitant. 3. Patient with pleural effusion or ascites which should be drainaged. 4. Patients have received chemotherapy including any drug except docetaxel, or radiation therapy within 3 weeks prior to registration. 5. Patients have hormonal therapy within 7 days prior to registration. 6. Women of childbearing potential and men of impregnating potential who don't agree to use adequate contraception, pregnant women, and lactating women. 7. History of severe hypersensitivity to a medicine. 8. Patients with the habit of smoking within one month prior to registration. 9. Patients with any conditions that are unstable or jeopardize the safety of the patient and his/her compliance in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare intra-patient phamacokinetics of docetaxel and dexamethasone under the three different conditions, which are as follows. A : without aprepitant. B1: In combination with aprepitant 3 hours prior to the administration of docetaxel, adjusting timing with Tmax of aprepitant. B2: In combination with aprepitant 1 hour prior to the administration of docetaxel according to the package insert.