Advanced Nonhematologic MalignanciesPhase 1NCT01204073
A Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies
A Phase 1 study testing TAK-441 in people with Advanced Nonhematologic Malignancies and Carcinoma, Basal Cell, run by Millennium Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
This is the first study in which TAK-441 is administered to humans. The patient population will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for whom standard treatment is no longer effective or does not offer curative or life-prolonging potential. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Nonhematologic Malignancies, Carcinoma, Basal Cell
- What is being tested?
- TAK-441
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Jan 2013
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- 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 or female 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential
- Meet other clinical, radiographic or laboratory inclusion criteria as specified in the protocol
- Voluntary written consent
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Life-threatening illness unrelated to cancer
- Receiving other treatment (radiotherapy, antineoplastics or investigational agents) within protocol specified windows of first dose of TAK-441
- Patients with brain metastases who do not meet criteria specified in study protocol
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
- Major surgery within 14 days before the first dose of TAK-441
- Infection requiring systemic therapy, or other serious infection within 14 days of the first dose of TAK-441
- Do not meet other clinical, laboratory or radiographic criteria as specified in the protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Premiere Oncology, A Medical Corporation
Santa Monica, California, 90404
Mayo Clinic
Scottsdale, Arizona, 85259-5499
About this study
Official title: A Multicenter, Open-Label, Dose-Escalation, Phase 1 Study of TAK-441, an Oral Hedgehog Signaling Pathway Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies
This is the first study in which TAK-441 is administered to humans. The patient population will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for whom standard treatment is no longer effective or does not offer curative or life-prolonging potential. Following completion of the dose escalation study, patients will be enrolled as part of 2 expansion cohorts.
- Being tested
- TAK-441
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-441Drug
TAK-441 will be administered as an oral tablet as follows:
Patients enrolled in the dose escalation cohorts will receive:
- A single-dose administration on Day 1, followed by a 1-week washout period during which pharmacokinetics is assessed
- Continuous daily dosing on Days 8 through 28 in Cycle 1
- In subsequent cycles, continuous daily dosing over 21 days, repeated continuously
Patients enrolled in the expansion cohorts will receive continuous daily dosing on Days 1 through 21 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| TAK-441 | Experimental | Not described Receives: Drug: TAK-441 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile, maximum tolerated dose (MTD) or maximum feasible dose (MFD) of TAK-441 administered as an oral formulation in patients wtih advanced nonhematologic malignancies
Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements
Measured: From first dose of TAK-441 through 30 days after the last dose of TAK-441
Secondary outcomes (4)
Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441
Including but not limited to maximum plasma concentration (Cmax), first time to plasma concentration (Tmax) and area under the plasma concentration versus time curve (AUC)
Measured: Sampling during Cycle 1 (Days 1-28)
Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin
Measured: Cycle 1 Day 22
Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only)
Measured: Cycle 1 Day 15
Antitumor activity of TAK-441 administered as a single-agent therapy based on investigators' assessments of tumor response in patients who have advanced basal cell carcinoma
Based on the investigator's assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Measured: Days 15-21 of cycles 2, 4 and every fourth cycle thereafter; and end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Nonhematologic MalignanciesStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT01204073
- Sponsor's protocol ID
- C24002
- Other IDs
- 2010-021311-17
- Status last verified
- Jul 2013
- First submitted
- 15 Sep 2010
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Dose-Escalation, Phase 1 Study of TAK-441, an Oral Hedgehog Signaling Pathway Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies
- ClinicalTrials.gov ID
- NCT01204073
- Acronym / sponsor ID
- C24002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 17 Sep 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.
This is the first study in which TAK-441 is administered to humans. The patient population will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for whom standard treatment is no longer effective or does not offer curative or life-prolonging potential. Following completion of the dose escalation study, patients will be enrolled as part of 2 expansion cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-441 | Experimental | Drug: TAK-441 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Male or female 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential
- Meet other clinical, radiographic or laboratory inclusion criteria as specified in the protocol
Key exclusion criteria (8 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Life-threatening illness unrelated to cancer
- Receiving other treatment (radiotherapy, antineoplastics or investigational agents) within protocol specified windows of first dose of TAK-441
- Patients with brain metastases who do not meet criteria specified in study protocol
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
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 |
|---|---|---|
| TAK-441TAK-441 will be administered as an oral tablet as follows: Patients enrolled in the dose escalation cohorts will receive: * A single-dose administration on Day 1, followed by a 1-week washout period during which pharmacokinetics is assessed * Continuous daily dosing on Days 8 through 28 in Cycle 1 * In subsequent cycles, continuous daily dosing over 21 days, repeated continuously Patients enrolled in the expansion cohorts will receive continuous daily dosing on Days 1 through 21 of each 21-day cycle | Drug | TAK-441 |
Primary outcome
Safety profile, maximum tolerated dose (MTD) or maximum feasible dose (MFD) of TAK-441 administered as an oral formulation in patients wtih advanced nonhematologic malignancies
Time frame: From first dose of TAK-441 through 30 days after the last dose of TAK-441
Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements
4 secondary outcomes
Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441
Time frame: Sampling during Cycle 1 (Days 1-28)
Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin
Time frame: Cycle 1 Day 22
Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only)
Time frame: Cycle 1 Day 15
Antitumor activity of TAK-441 administered as a single-agent therapy based on investigators' assessments of tumor response in patients who have advanced basal cell carcinoma
Time frame: Days 15-21 of cycles 2, 4 and every fourth cycle thereafter; and end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-441 in people with Advanced Nonhematologic Malignancies and Carcinoma, Basal Cell, run by Millennium Pharmaceuticals, Inc. at 2 sites in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety profile, maximum tolerated dose (MTD) or maximum feasible dose (MFD) of TAK-441 administered as an oral formulation in patients wtih advanced nonhematologic malignancies (time frame: From first dose of TAK-441 through 30 days after the last dose of TAK-441). 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 2 Jul 2013.