- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01132404
Study in Men With Prostate Cancer to Assess the Safety, Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448
A Phase 1/2, Open Label Study in Men With Prostate Cancer to Assess the Safety. Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448, Administered as a 1-Month Depot, Including a Randomized Portion With a Group Administered Leuprorelin
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69437
- Hôpital Edouard Herriot, 5, Place d'Arsonval, Pavillon V - Urologie et chirurgie de la transplantation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Male 40 to 72 years of age
- Histologically-confirmed adenocarcinoma of the prostate having completed primary local treatment at least 6 months prior to screening
- Meet all laboratory evaluation values at screening as specified in protocol
- For phase 1 of the study only: Concurrent gonadotropin releasing hormone (GnRH) therapy with generally indolent or stable disease OR a potential candidate of GnRH at some time in the future. Patients with metastatic disease must be asymptomatic with only bone scan positive evidence of metastases. Patients with recurrent local disease will be asymptomatic without bladder, bowel or obstructive symptoms
- For phase 2 portion of the study only: evidence of progressive prostate cancer, which in the opinion of the referring physician and/or study investigator warrants the initiation of GnRH analog therapy. Such patients may have either elevated or rising PSA at least 6 months following primary local therapy (ies) or have evidence of metastatic disease not previously treated with GnRH analog therapy.
- Provision of informed consent and for the phase 1 portion of the study only, willing to participate with no expectation of therapeutic benefit
- Generally fit medical condition, with no acute or chronic medical conditions other than prostate cancer, affecting 2-year life expectancy
- Ability to understand and comply with protocol requirements
- Agreement to, even if surgically sterilized but not surgically castrated, practice effective barrier contraception OR abstain from heterosexual intercourse
- Suitable venous access for blood sampling
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in either the phase 1 or phase 2 portion of the study:
- Advanced or symptomatic metastatic prostate cancer requiring immediate GnRH or additional hormone therapy or requiring chemotherapy
- History of surgical castration
- History of nonskin cancer, other than prostate cancer, requiring active treatment within 2 years of screening
- History of cardiac surgery, within the previous 6 months or any planned elective surgeries, other than skin surgery, during the ensuing 6 months
- Compromise of bone marrow function that would reduce tolerance to repeated blood draws
- History of osteoporosis, unless actively controlled with treatment, or history of vertebral or femoral fracture within the past year
- History of seizures or currently on anticonvulsant medications
- History of major psychiatric illness (diagnosed psychosis or psychiatric illness requiring hospitalization)
- History of drug or significant alcohol abuse
- Participation in clinical trials or receipt of experimental therapy within 2 months of screening
- Serious infection within 14 days before first dose of study drug
- Known history of human immunodeficiency (HIV) infection, hepatitis B, or hepatitis C infection
- History of significant cardiovascular condition
In addition, for the phase 2 portion of the study, patients must not have any of the following exclusion criteria:
- Participation in the phase 1 portion of the study
- Prior or current use of a GnRH analog or androgen receptor antagonist as first-line hormone therapy (other than as neoadjuvant/adjuvant use)
- History of use of GnRH analog or antagonist (as adjuvant or neoadjuvant therapy) within the 6 months prior to screening
- History of known or documented primary failure of GnRH analog therapy
- History of rising PSA or disease progression while on a GnRH analog or combined androgen blockade (CAB) therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAK-448 Dose 1
|
Phase 1 portion of study: Patients will be administered a single dose of depot formulation TAK-448 via subcutaneous abdominal injection and a single dose of placebo at a contralateral injection site Phase 2 portion of the study: Patients randomized to this arm will be administered depot formulation TAK-448 (up to 2 dose levels) via subcutaneous injection in the abdomen once per month for up to 6 months |
Experimental: TAK-448 Dose 2
|
Phase 1 portion of study: Patients will be administered a single dose of depot formulation TAK-448 via subcutaneous abdominal injection and a single dose of placebo at a contralateral injection site Phase 2 portion of the study: Patients randomized to this arm will be administered depot formulation TAK-448 (up to 2 dose levels) via subcutaneous injection in the abdomen once per month for up to 6 months |
Active Comparator: Leuprorelin
|
Phase 2 portion of study: patients randomized to this arm will receive a subcutaneous injection of depot Leuprorelin in the abdomen once per month for up to 6 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
For Phase 1 portion of study: to assess the safety and pharmacokinetics (PK) of TAK-448 in patients receiving a single dose of 1-month depot TAK-448
Time Frame: 3 months
|
Vital signs; 12-lead ECG; Clinical laboratory test results; Injection site-related skin reactions; Adverse Events (AEs)and Serious Adverse Events (SAEs); Maximum observed plasma concentration; Area under the plasma TAK-448 disposition curve; The time of last quantifiable concentration
|
3 months
|
For Phase 2 portion of study: to assess the safety and PK of TAK-448 and effect of TAK-448 on serum testosterone concentrations in patients receiving repeated doses of 1-month depot TAK-448
Time Frame: 8 months
|
Vital signs; 12-lead ECG; Clinical laboratory test results; Injection site-related skin reactions; Adverse Events (AEs)and Serious Adverse Events (SAEs; Area under the plasma TAK-448 disposition curve; trough plasma concentration; Serum testosterone concentration; proportion of patients with serum concentration below castrate level
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
For Phase 1 portion of study: to assess the effect of 1-month depot TAK-448 on serum testosterone and luteinizing hormone (LH) concentrations in patients not receiving concomitant gonadotropin releasing hormone (GnRH) analog therapy
Time Frame: 3 months
|
Serum testosterone and LH concentrations; proportions of patients with serum testosterone concentrations below castrate-level
|
3 months
|
For Phase 2 portion of study: to assess the effect of 1-month depot TAK-448 on serum prostate specific antigen (PSA) concentration
Time Frame: 8 months
|
Serum PSA concentration
|
8 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C18002
- 2009-017668-18 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostatic Neoplasms
-
Australian and New Zealand Urogenital and Prostate...Peter MacCallum Cancer Centre, AustraliaRecruitingCastration Resistant Prostatic CancerAustralia
-
Technische Universität DresdenRecruitingOligometastatic Disease | Prostatic Cancer, Castration-ResistantGermany
-
British Columbia Cancer AgencySanofi; Ozmosis Research Inc.UnknownMetastatic Castration-Resistant Prostatic CancerCanada, Australia
-
Janssen Research & Development, LLCCompletedCastration-Resistant Prostatic NeoplasmsCanada, Belgium, United States, Spain, Netherlands, Italy, Russian Federation
-
Yinghao SunNot yet recruitingCastration-Resistant Prostatic Cancer
-
Institut Claudius RegaudWithdrawnProstatic Cancer, Castration-ResistantFrance
-
Universität des SaarlandesRecruitingProstate Cancer Metastatic | Advanced Prostate Carcinoma | Castration Resistant Prostatic CancerGermany
-
University Hospital, GrenobleTerminatedCastration-resistant Prostate CancerFrance
-
Michael Graham PhD, MDUniversity of Iowa; Holden Comprehensive Cancer CenterActive, not recruitingProstate Cancer | Prostatic Neoplasms, Castration-Resistant | Prostatic Neoplasm | Prostatic Cancer Recurrent | Prostatic Cancer MetastaticUnited States
-
Rio de Janeiro State UniversityCompletedProstatic Cancer | Prostatic NeoplasmBrazil
Clinical Trials on TAK-448
-
TakedaTerminatedLow TestosteroneUnited States
-
TakedaTerminatedHypogonadotropic HypogonadismUnited Kingdom
-
University of MalagaCompletedUltrasonography | ShoulderSpain
-
ValbiotisUniversity Hospital, Clermont-Ferrand; Clinic'n'CellRecruitingNAFLD | MASLD | Mild Inflammatory ContextFrance
-
iTeos Belgium SACompleted
-
Universidad de GranadaNot yet recruiting
-
University of Castilla-La ManchaCastilla-La Mancha Health Service; Hospital General Nuestra Señora del Prado; Indiba S.A...CompletedSubacromial Impingement Syndrome | Shoulder Impingement SyndromeSpain
-
Fundacio Espai SalutHospital Clinic of Barcelona; Corporación Fisiogestión S.A.; Agència d'Avaluació...Unknown
-
University of MalagaUnknown