Safety Study of TAK-700 in Subjects With Prostate Cancer.

Sponsor

Millennium Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00569153

Collaborator

(none)

123

Enrollment

Locations

Arms

58.1

Duration (Months)

6.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the safety and tolerability of TAK-700 in patients with asymptomatic metastatic, androgen independent prostate cancer.

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms	Drug: TAK-700	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1/2, Open-Label, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Metastatic, Androgen-Independent Prostate Cancer Subjects

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 (TAK-700)	Drug: TAK-700 Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments: TAK-700 at 300 mg twice/day TAK-700 at 400 mg and 5 mg prednisone twice/day TAK-700 at 600 mg and 5 mg prednisone twice/day TAK-700 at 600 mg once/day in the morning
Experimental: Arm 2 (TAK-700 at 400 mg & 5 mg prednisone)	Drug: TAK-700 Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments: TAK-700 at 300 mg twice/day TAK-700 at 400 mg and 5 mg prednisone twice/day TAK-700 at 600 mg and 5 mg prednisone twice/day TAK-700 at 600 mg once/day in the morning
Experimental: Arm 3 (TAK-700 at 600 mg & 5 mg prednisone)	Drug: TAK-700 Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments: TAK-700 at 300 mg twice/day TAK-700 at 400 mg and 5 mg prednisone twice/day TAK-700 at 600 mg and 5 mg prednisone twice/day TAK-700 at 600 mg once/day in the morning
Experimental: Arm 4 (TAK-700 at 600 mg)	Drug: TAK-700 Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments: TAK-700 at 300 mg twice/day TAK-700 at 400 mg and 5 mg prednisone twice/day TAK-700 at 600 mg and 5 mg prednisone twice/day TAK-700 at 600 mg once/day in the morning

Outcome Measures

Primary Outcome Measures

Safety and tolerability of TAK-700 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests. [Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.]

Secondary Outcome Measures

Efficacy and pharmacokinetics (PSA response and/or objective disease response) [Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is male and at least 18 years of age.
Subject has histologically- or cytologically-confirmed prostate adenocarcinoma with metastatic, progressive disease while on androgen deprivation therapy.
Subject has radiograph-documented (computed tomography, magnetic resonance imaging or x-ray) metastatic disease.
Subject has undergone orchiectomy or is expected to continue receiving luteinizing hormone-releasing hormone analogue therapy, and has a testosterone level of <50 ng/dL at screening.
Subject has discontinued all antiandrogen therapy (within 30 days for flutamide and within 6 weeks for all others) prior to their first dose of study drug.
Subject has a prostate-specific antigen level ≥5 ng/mL.
Subject meets all screening laboratory values as specified in the protocol.
Subject has a screening ejection fraction that is above the lower limit of the institutional normal range.
Subject has ECOG performance status of 0 to 2.
Subject has normal or, in the opinion of the investigator, clinically insignificant, physical examination findings, ECG and chest x-ray results.
Subjects, even if surgically sterilized (ie, status postvasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.

Exclusion Criteria:

Subject has known hypersensitivity to TAK-700 or related compounds.
Subject has received prior therapy with aminoglutethimide or ketoconazole within 30 days prior to the first dose of study drug.
Subject has received prior chemotherapy for prostate cancer.
Subject has received any investigational compound within 30 days prior to first dose of study drug.
Subject has received prior herbal product known to decrease prostate-specific antigen levels (eg, Saw Palmetto, PC-SPES) within 30 days prior to the first dose of study drug.
Subject has received radiation therapy for prostate cancer within 30 days prior to first dose of study drug.
Chronic therapy with oral or other systemically administered corticosteroids, such as prednisone, within 30 days prior to Screening. Chronic therapy is defined as the use of corticosteroids for more than 7 days within a 30-day period.
Subject has current spinal cord compression, current bilateral hydronephrosis, or current bladder neck outlet obstruction.
Subject has a history of adrenal insufficiency.
Subject has a history of myocardial infarction, ischaemic symptomatic heart disease, cardiac arrhythmias or thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 12 months prior to first dose of study drug.
Subject has any symptoms which the investigator deems related to prostate cancer, i.e., bone pain, pelvic pain.
Subject has a history of congestive heart failure (New York Heart Association Class II or greater.
Subject has history of another malignancy other than basal cell carcinoma or state 1 squamous cell carcinoma of the skin, within the last 5 years.
Subject has uncontrolled hypertension.
Subject is known to have HIV infection, chronic Hepatitis B or C or any other serious medical condition or psychiatric illness that might affect life expectancy or make it difficult to successfully manage and follow the subject according to protocol.
Subject is unable to understand verbal or written English or any other language for which a certified translation of the institutional review board (IRB)-approved informed consent has been provided.
Subject is unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC Westside Prostate Cancer Center	Beverly Hills	California	United States
2	University of Southern California	Los Angeles	California	United States	90048
3	The Angeles Clinic and Research Institute	Los Angeles	California	United States
4	USC Norris Comprehensive Cancer Center	Los Angeles	California	United States
5	South Florida Medical Research	Aventura	Florida	United States
6	Florida Cancer Specialists	Fort Myers	Florida	United States
7	Northwestern University Medical Center	Chicago	Illinois	United States	60611
8	University of Chicago	Chicago	Illinois	United States	60637
9	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States
10	University of Chicago Pharmacy	Chicago	Illinois	United States
11	Evanston Hospital	Evanston	Illinois	United States
12	Kellogg Pharmacy - Evanston Hospital	Evanston	Illinois	United States
13	NorthShore University HealthSystem	Evanston	Illinois	United States
14	Kellogg Cancer Care Center	Glenview	Illinois	United States
15	Hematology/Oncology Associates of Central New York	East Syracuse	New York	United States
16	Gabrail Cancer Center	Canton	Ohio	United States
17	Cleveland Clinic	Cleveland	Ohio	United States	44195
18	Taussig Cancer Institute	Cleveland	Ohio	United States
19	Tennessee Oncology	Nashville	Tennessee	United States

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

Study Director: Medical Monitor, Millennium Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Millennium Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00569153

Other Study ID Numbers:

TAK-700_201
TAK-700-201

First Posted:

Dec 6, 2007

Last Update Posted:

Apr 4, 2016

Last Verified:

Mar 1, 2016

Keywords provided by Millennium Pharmaceuticals, Inc.

Androgen-independent prostate cancer, metastatic

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Apr 4, 2016