Prostate CancerPhase 1/2NCT01132404
Study in Men With Prostate Cancer to Assess the Safety, Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448
A Phase 1/2 study testing Leuprorelin and TAK-448 in people with Prostate Cancer and Prostatic Neoplasms, run by Millennium Pharmaceuticals, Inc. at 1 site in France.
Trial summary
The phase 1 portion of this study is an open-label, multicenter, dose-escalation study of 1-month depot TAK-448 in adult males with prostate cancer who are either on gonadotropin releasing hormone (GnRH) therapy or who might be eligible for GnRH therapy in the future. Read more about this study
- Who is it for?
- Ages 40 to 72 years, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasms
- What is being tested?
- Leuprorelin and TAK-448
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 72 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Edouard Herriot, 5, Place d'Arsonval, Pavillon V - Urologie et chirurgie de la transplantation
Lyon, 69437
About this study
Official title: 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
The phase 1 portion of this study is an open-label, multicenter, dose-escalation study of 1-month depot TAK-448 in adult males with prostate cancer who are either on gonadotropin releasing hormone (GnRH) therapy or who might be eligible for GnRH therapy in the future. The phase 2 portion of this study is an open-label, multicenter, randomized study in men with prostate cancer that will confirm the testosterone- and prostate specific antigen (PSA)- lowering potential of up to 2 dose levels of 1-month depot TAK-448.
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Being tested
- Leuprorelin, TAK-448
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprorelinDrug
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
TAK-448Drug
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
| Study group | Role | What they receive |
|---|---|---|
| TAK-448 Dose 1 | Experimental | Not described Receives: Drug: TAK-448 |
| TAK-448 Dose 2 | Experimental | Not described Receives: Drug: TAK-448 |
| Leuprorelin | Active comparator | Not described Receives: Drug: Leuprorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: 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
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
Measured: 8 months
Secondary outcomes (2)
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
Serum testosterone and LH concentrations; proportions of patients with serum testosterone concentrations below castrate-level
Measured: 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
Serum PSA concentration
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionDec 2011
Why it stopped: Developing new formulation of study drug. New study to open next year under a new protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132404
- Sponsor's protocol ID
- C18002
- Other IDs
- 2009-017668-18, 2009
- Status last verified
- Jan 2012
- First submitted
- 26 May 2010
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01132404
- Acronym / sponsor ID
- C18002
- Conditions
- Prostate Cancer, Prostatic Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Developing new formulation of study drug. New study to open next year under a new protocol.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The phase 1 portion of this study is an open-label, multicenter, dose-escalation study of 1-month depot TAK-448 in adult males with prostate cancer who are either on gonadotropin releasing hormone (GnRH) therapy or who might be eligible for GnRH therapy in the future. The phase 2 portion of this study is an open-label, multicenter, randomized study in men with prostate cancer that will confirm the testosterone- and prostate specific antigen (PSA)- lowering potential of up to 2 dose levels of 1-month depot TAK-448.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAK-448 Dose 1 | Experimental | Drug: TAK-448 |
| TAK-448 Dose 2 | Experimental | Drug: TAK-448 |
| Leuprorelin | Active comparator | Drug: Leuprorelin |
Who may qualify
- Ages
- 40 to 72 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeuprorelinPhase 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 | Drug | Leuprorelin |
| TAK-448Phase 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 | Drug | TAK-448 Dose 1, TAK-448 Dose 2 |
Primary outcome
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
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
2 secondary outcomes
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
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
Results and safety
The study was stopped early (reason given: Developing new formulation of study drug. New study to open next year under a new protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Millennium Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Leuprorelin and TAK-448 in people with Prostate Cancer and Prostatic Neoplasms, run by Millennium Pharmaceuticals, Inc. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Developing new formulation of study drug. New study to open next year under a new protocol.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2012.