Advanced Non-hematologic MalignanciesPhase 1NCT00948467
Study of TAK-733 in Adult Patients With Advanced Nonhematologic Malignancies
A Phase 1 study testing TAK-733 in people with Advanced Non-hematologic Malignancies and Advanced Metastatic Melanoma, run by Millennium Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and maximum tolerated dose of TAK-733 in patients with advanced, nonhematologic tumors. The expansion stage of the study will evaluate evidence of antitumor activity of TAK-733 in patients with advanced metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-hematologic Malignancies, Advanced Metastatic Melanoma
- What is being tested?
- TAK-733
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Jun 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:
- 18 years or older.
- Have one of the following diagnoses: a nonhematologic malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective; OR have stage 3 or stage 4 unresectable melanoma not priorly treated with either MEK or BRAF inhibitor therapy.
- Melanoma patients should have the V600E BRAF mutation status of their tumor documented, if available, and tumor tissue must be provided for confirmatory genotyping by a central laboratory.
- Have a radiographically or clinically evaluable tumor.
- Have suitable venous access for the conduct of blood sampling.
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- Provide voluntary written consent, which can be withdrawn by the patient at any time.
- Female patients who: are post-menopausal for at least 1 year before screening; OR are surgically sterile; OR if they are of childbearing potential agree to practice two effective methods of birth control from the time of signing the informed consent form through 30 days after the last dose of the study drug, or agree to completely abstain from heterosexual intercourse.
- Male patients, even if surgically sterilized, must agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of the study drug; OR agree to completely abstain from heterosexual intercourse.
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female patients who are lactating or have a positive serum pregnancy test during the Screening period.
- Antineoplastic therapy or radiotherapy within 21 days; or nitrosoureas of mitomycin C within 42 days
- Prior biologic or immunotherapy ≤ 4 weeks prior to enrollment.
- Grade 2 or greater unresolved toxicity (except alopecia) from previous anticancer therapy.
- Major surgery within 14 days of the first dose of the study drug.
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- An active infection requiring systemic therapy; or other severe infection.
- Symptomatic brain metastases.
- Inability to meet specific laboratory test standards during the Screening period as specified in the study protocol.
- Human Immunodeficiency (HIV) positive.
- Hepatitis B surface antigen positive or active hepatitis C infection.
- Serious medical or psychiatric illness likely to interfere with the study.
- Uncontrolled cardiovascular condition.
- Abnormalities on 12-lead ECG performed within 28 days before the start of the study drug that are considered to be clinically significant or rate corrected QT interval > 470 milliseconds.
- Melanoma patients will be excluded if they have had a diagnosis with or treatment for another malignancy within 2 years of the first dose of the study drug, or have been previously diagnosed with another malignancy with any evidence of residual disease.
- Treatment with any investigational product within 28 days before the first dose of the study drug.
- A history of an ongoing or newly diagnosed eye abnormality, such as retinal or corneal pathologies.
- Abnormal left ventricular ejection fraction (LVEF).
- Receiving therapeutic anticoagulation
- Treatment with any of the following strong CYP3A inhibitors or inducers within 14 days before the first dose of study drug: ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, rifampin, rifapentine, or rifabutin.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Wayne State University Karmanos Cancer Institute
Detriot, Michigan, 48201
About this study
Official title: A Multicenter, Open-label, Dose-escalation, Phase I Study of TAK-733, an Oral MEK Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies
The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and maximum tolerated dose of TAK-733 in patients with advanced, nonhematologic tumors. The expansion stage of the study will evaluate evidence of antitumor activity of TAK-733 in patients with advanced metastatic melanoma.
- Being tested
- TAK-733
- Keywords
- Advanced nonhematologic malignancies, Advanced metastatic melanoma, BRAF gene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-733Drug
The Initial Escalation Stage will enroll approximately 30 patients with advanced nonhematologic malignancies. TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days.
The Expansion Stage will enroll approximately 30 patients with advanced metastatic melanoma. The recommended phase 2 dose determined in the Initial Escalation Stage of TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| TAK-733 | Experimental | Not described Receives: Drug: TAK-733 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile, dose-limiting toxicities, maximum tolerated dose and recommended phase 2 dose of TAK-733
Measured: 12 months
Pharmacokinetic characterization of TAK-733
Measured: 12 months
Secondary outcomes (3)
Effect of food on the pharmacokinetics of TAK-733
Measured: 12 months
Antitumor activity of TAK-733 in patients with advanced nonhematologic malignancies
Measured: 12 months
Antitumor activity of TAK-733 in melanoma patients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-hematologic 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
- 51 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
- NCT00948467
- Sponsor's protocol ID
- C20001
- Status last verified
- Jun 2013
- First submitted
- 27 Jul 2009
- Last updated
- 2 Jul 2013
- Results posted
- 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 I Study of TAK-733, an Oral MEK Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies
- ClinicalTrials.gov ID
- NCT00948467
- Acronym / sponsor ID
- C20001
- Keywords
- Advanced nonhematologic malignancies, Advanced metastatic melanoma, BRAF gene
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jul 2009 (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 purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics and maximum tolerated dose of TAK-733 in patients with advanced, nonhematologic tumors. The expansion stage of the study will evaluate evidence of antitumor activity of TAK-733 in patients with advanced metastatic melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-733 | Experimental | Drug: TAK-733 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- 18 years or older.
- Have one of the following diagnoses: a nonhematologic malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective; OR have stage 3 or stage 4 unresectable melanoma not priorly treated with either MEK or BRAF inhibitor therapy.
- Melanoma patients should have the V600E BRAF mutation status of their tumor documented, if available, and tumor tissue must be provided for confirmatory genotyping by a central laboratory.
- Have a radiographically or clinically evaluable tumor.
Key exclusion criteria (20 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female patients who are lactating or have a positive serum pregnancy test during the Screening period.
- Antineoplastic therapy or radiotherapy within 21 days; or nitrosoureas of mitomycin C within 42 days
- Prior biologic or immunotherapy ≤ 4 weeks prior to enrollment.
- Grade 2 or greater unresolved toxicity (except alopecia) from previous anticancer therapy.
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-733The Initial Escalation Stage will enroll approximately 30 patients with advanced nonhematologic malignancies. TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days. The Expansion Stage will enroll approximately 30 patients with advanced metastatic melanoma. The recommended phase 2 dose determined in the Initial Escalation Stage of TAK-733 will be administered orally in 28-day treatment cycles consisting of intermittent dosing with 21 days of continuous treatment, followed by a rest period of 7 days. | Drug | TAK-733 |
Primary outcome
Safety profile, dose-limiting toxicities, maximum tolerated dose and recommended phase 2 dose of TAK-733
Time frame: 12 months
Pharmacokinetic characterization of TAK-733
Time frame: 12 months
3 secondary outcomes
Effect of food on the pharmacokinetics of TAK-733
Time frame: 12 months
Antitumor activity of TAK-733 in patients with advanced nonhematologic malignancies
Time frame: 12 months
Antitumor activity of TAK-733 in melanoma patients
Time frame: 12 months
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.
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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.
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-733 in people with Advanced Non-hematologic Malignancies and Advanced Metastatic Melanoma, 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 9 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: 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, dose-limiting toxicities, maximum tolerated dose and recommended phase 2 dose of TAK-733 (time frame: 12 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 2 Jul 2013.