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Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

Information source: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: TAK-700 (Drug); Docetaxel (Drug); Prednisone (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Millennium Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Millennium Pharmaceuticals, Inc.

Summary

This is an open-label, multicenter, Phase 1/2 study of TAK-700 in combination with docetaxel and prednisone that will evaluate the safety and pharmacokinetics (PK) of the combination and will allow estimation of prostate-specific antigen (PSA) response in men with metastatic castration-resistant prostate cancer (mCRPC).

Clinical Details

Official title: An Open-label Phase 1/2 Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

To confirm the maximum dose of TAK-700 that can be safely administered in combination with docetaxel and prednisone

To characterize the pharmacokinetics (PK) of docetaxel and TAK-700 alone and in combination

To obtain an estimate of prostate-specific antigen (PSA) response rates

Secondary outcome:

To assess time to prostate-specific antigen (PSA) progression and time to radiographic disease progression

To assess measurable disease response

To assess changes in circulating tumor cell (CTC) counts

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria: Each patient must meet all of the following inclusion criteria:

- Voluntary written consent

- Male patients 18 years or older

- Estimated life expectancy of 6 months or more

- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma

- Radiograph-documented metastatic disease

- Progressive disease

- Prior surgical castration or concurrent use of an agent for medical castration

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Physical examination findings that are consistent with other study entry or exclusion

criteria and identified but not excluded chronic conditions

- Even if surgically sterilized, patients must Practice effective barrier contraception

during the entire study treatment period through 6 months after the last dose of study drug, OR Abstain from heterosexual intercourse

- Any use of opiates must be stable for at least 2 weeks prior to study entry

- Meet screening laboratory values as specified in protocol

- Suitable venous access

Exclusion Criteria: Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

- Known hypersensitivity to TAK-700, docetaxel, prednisone or related compounds

- Received any of the following within 30 days prior to the first dose of TAK-700:

prior therapy with any investigational compound; prior herbal product known to decrease PSA; OR radiation therapy for prostate cancer

- Received prior therapy with TAK-700, aminoglutethimide, ketoconazole or abiraterone

(for Phase 1 only, patients previously treated with ketoconazole or abiraterone will be eligible if treatment with ketoconazole or abiraterone was discontinued at least 30 days prior to enrollment)

- Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others

prior to first dose of study drug

- Received prior chemotherapy for prostate cancer

- Current spinal cord compression, bilateral hydronephrosis or neck outlet obstruction

- Symptoms that investigator deems related to prostate cancer

- Diagnosis or treatment of another malignancy within 2 years preceding first dose of

study drug except nonmelanoma skin cancer or in situ malignancy completely resected

- Uncontrolled cardiovascular condition

- New York Heart Association Class (NYHA) Class III or IV

- Uncontrolled hypertension despite medical therapy

- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or

hepatitis C

- Unwilling or unable to comply with protocol

- Major surgery or serious infection within 14 days of first dose of TAK-700

- Life-threatening illness unrelated to cancer

- Uncontrolled nausea, vomiting or diarrhea

- Known gastrointestinal disease or procedure that could interfere with oral absorption

or tolerance of TAK-700

Locations and Contacts

Alaska Clinical Research Center, LLC, Anchorage, Alaska 99508, United States
Additional Information

Starting date: July 2010
Last updated: July 1, 2013

Page last updated: August 23, 2015

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