A Phase 1, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Hormone Therapy-Resistant Prostate Cancer Subjects

Phase 1

• Conditions: Prostate cancer

• Registration Number: JPRN-jRCT2080220970
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria include the following:
1. Japanese patients histologically or cytologically diagnosed with prostate cancer
2. Undergone orchiectomy or receiving hormone therapy with an LH-RH agonist, with serum testosterone < 0.5 ng/mL at screening
3. PSA => 2 ng/mL at screening
4. Increase from nadir PSA in two or more successive measurements before screening* (The measurements must be made at least one week apart at the same laboratory.)
*Even if the patient's PSA level at the second measurement is not higher than the increased PSA level at the first measurement, he is regarded to meet this criterion if his PSA level at the third measurement is higher than the first increased PSA level.
5. No use of any antiandrogens during a period specified below:
1) Bicalutamide: => 6 weeks (42 days) prior to the first dose of the investigational product
2) Other antiandrogens: => 4 weeks (28 days) prior to the first dose of the investigational product
6. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2 at screening
7. Judged to have no clinical problems based on physical examination, echocardiography, ECG, and chest X-ray at screening.
8. Left ventricular ejection fraction (LVEF) at screening at or above the lower limit of the institutional normal range.
9. Cardiac enzymes (creatinine kinase-MB [CK-MB] and cardiac troponin T) at screening within the institutional normal range.
And the others.

Exclusion Criteria

Exclusion criteria include the following:
1. Prior chemotherapy
2. Prior Estramustine therapy
3. Prior 125I seed implants brachytherapy
4. Use of any of the following therapies for prostate cancer within 16 weeks (112 days) prior to the first dose of the investigational product: high intensity focused ultrasound, prostatectomy, radiation therapy (except 125I seed implants brachytherapy)
5. Use of any of the following within 4 weeks (28 days) prior to the first dose of the investigational product: androgen preparations, estrogen preparations (except estramustine), 5 alpha-reductase inhibitors (i.e., finasteride, dutasteride), zoledronate, Chinese herbal medicines including Saw Palmetto, and supplements
6. Use of any of the following within 4 weeks (28 days) prior to the first dose of the investigational product: spironolactone and corticosteroids (with the exception of inhaled and topical steroids)
7. Use of any prior therapy for prostate cancer (e.g., ketoconazole [with the exception of topical formulations]) within 4 weeks (28 days) prior to the first dose of the investigational product
8. Active multiple primary cancers (synchronous multiple primary cancers, or metachronous multiple primary cancers with a disease-free period of 5 years or less).
9. Past or concomitant adrenal insufficiency
10. History of any condition that may interfere with absorption of the investigational product and thus affect the pharmacokinetic evaluation (e.g., gastrectomy, extensive resection of the small intestine)
11. History of any of the following within 12 months (364 days) prior to enrollment in the study: myocardial infarction, symptomatic ischaemic heart disease, cardiac arrhythmias, thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or other cardiac conditions (e.g., pericardial effusion and restrictive cardiomyopathy)
12. Past or concomitant congestive heart failure of New York Heart Association (NYHA) Class II or greater
13. Concurrent presence of poorly controlled or refractory hypertension, as defined by the Guidelines for the Management of Hypertension, 2009.
And the others

Study & Design

• Study Type: Interventional
• Study Design: Not specified