Advanced Nonhematologic MalignanciesPhase 1NCT01613261
Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies
A Phase 1 study testing TAK-733 and alisertib in people with Advanced Nonhematologic Malignancies, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is a Multicenter, Open-label, Phase 1b Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Nonhematologic Malignancies
- What is being tested?
- TAK-733 and alisertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2015
- 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
- Male or female patients 18 years or older
- Patients must have a diagnosis of a solid tumor malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective
- Radiographically or clinically evaluable tumor
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse
- Male patients who agree to practice effective barrier contraception through 4 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
- Voluntary written consent
- Clinical laboratory values as specified in the protocol
Who cannot join
- Female patients who are breastfeeding and lactating or pregnant
- Serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
- Treatment with any investigational products within 28 days before the first dose of study drug
- Prior treatment with Aurora A-targeted agents, including alisertib
- Prior treatment with MEK inhibitors, including TAK-733
- Prior treatment with BRAF inhibitors
Show all 18Show fewer
- Systemic anticancer therapy within 21 days before the first dose
- Prior biologic or immunotherapy within 28 days before the first dose
- Major surgery or serious infection within 14 days before the first dose
- Life-threatening illness unrelated to cancer
- Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C
- Cardiac condition as specified in study protocol or severe CNS, pulmonary, renal or hepatic disease
- Known GI conditions or GI procedure that could interfere with the oral absorption or tolerance of study drugs
- History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
- History of ongoing or a newly diagnosed eye abnormality
- Symptomatic brain metastases
- Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
- Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
About this study
Official title: A Multicenter, Open-label, Phase 1b Study of TAK-733 (an Oral MEK Inhibitor) in Combination With Alisertib (an Oral Aurora A Kinase Inhibitor) in Adult Patients With Advanced Nonhematologic Malignancies
This is a Multicenter, Open-label, Phase 1b Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies
- Conditions
- Advanced Nonhematologic Malignancies
- Being tested
- TAK-733 and alisertib
- Keywords
- TAK-733,, alisertib,, MLN8237,, Oral MEK Inhibitor,, Oral Aurora A Kinase Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-733 and alisertibDrug
TAK-733 will be administered orally once daily (QD) on Days 1 through 14 of the 21-day cycle.
Alisertib will be administered orally twice daily (BID) on Days 1 through 7 of the 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| TAK-733 and alisertib | Experimental | Not described Receives: Drug: TAK-733 and alisertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), assessments of clinical laboratory values, and vital sign measurements
To evaluate the safety profile and to determine DLTs, MTDs, and RP2D of oral TAK-733 + alisertib in patients with advanced nonhematologic malignancies
Measured: From signing of the informed consent form through 30 days after the last dose of study drug
TAK-733 and alisertib PK parameters including, but not limited to Cmax, Tmax, Area Under Curve (AUC), apparent oral clearance (CL/F), peak-to-trough ratio, and accumulation ratio
To characterize the single- and multiple-dose plasma PK of TAK-733 and alisertib in patients with advanced nonhematologic malignancies
Measured: Escalation and MTD Refinement: Cycle 1-Day 1, 2, 7, 8, 14,and 15; Tumor Expansion Cohort: Cycle 1-Day 1, 7, 8, and 15; Cycle 2-Day 1, 8,and 15; PK Expansion Cohort: Cycle 1-Day 1, 7, and 8; Cycle 2-Day 7, 14, and 15. Each cycle is a 21 days cycle
Secondary outcomes (1)
Measures of disease response, including objective response rate and duration of response based on investigator's assessment using RECIST guidelines
To evaluate evidence of antitumor activity of TAK-733 + alisertib
Measured: On screening; Cycle 2: between Day 15 and 21, and every third cycle thereafter (5,8,11 etc.) until progressive disease for approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startAug 2013
- Primary completionSep 2015 (estimated)
- Study completionNov 2015 (estimated)
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
- 0 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
- NCT01613261
- Sponsor's protocol ID
- C20002
- Other IDs
- 2012-000831-22
- Status last verified
- Oct 2013
- First submitted
- 1 Jun 2012
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 1b Study of TAK-733 (an Oral MEK Inhibitor) in Combination With Alisertib (an Oral Aurora A Kinase Inhibitor) in Adult Patients With Advanced Nonhematologic Malignancies
- ClinicalTrials.gov ID
- NCT01613261
- Acronym / sponsor ID
- C20002
- Conditions
- Advanced Nonhematologic Malignancies
- Keywords
- TAK-733,, alisertib,, MLN8237,, Oral MEK Inhibitor,, Oral Aurora A Kinase Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 7 Jun 2012 (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 a Multicenter, Open-label, Phase 1b Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies
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 and alisertib | Experimental | Drug: TAK-733 and alisertib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients 18 years or older
- Patients must have a diagnosis of a solid tumor malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective
- Radiographically or clinically evaluable tumor
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse
Key exclusion criteria (18 listed)
- Female patients who are breastfeeding and lactating or pregnant
- Serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
- Treatment with any investigational products within 28 days before the first dose of study drug
- Prior treatment with Aurora A-targeted agents, including alisertib
- Prior treatment with MEK inhibitors, including TAK-733
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-733 and alisertibTAK-733 will be administered orally once daily (QD) on Days 1 through 14 of the 21-day cycle. Alisertib will be administered orally twice daily (BID) on Days 1 through 7 of the 21-day cycle. | Drug | TAK-733 and alisertib |
Primary outcome
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), assessments of clinical laboratory values, and vital sign measurements
Time frame: From signing of the informed consent form through 30 days after the last dose of study drug
To evaluate the safety profile and to determine DLTs, MTDs, and RP2D of oral TAK-733 + alisertib in patients with advanced nonhematologic malignancies
TAK-733 and alisertib PK parameters including, but not limited to Cmax, Tmax, Area Under Curve (AUC), apparent oral clearance (CL/F), peak-to-trough ratio, and accumulation ratio
Time frame: Escalation and MTD Refinement: Cycle 1-Day 1, 2, 7, 8, 14,and 15; Tumor Expansion Cohort: Cycle 1-Day 1, 7, 8, and 15; Cycle 2-Day 1, 8,and 15; PK Expansion Cohort: Cycle 1-Day 1, 7, and 8; Cycle 2-Day 7, 14, and 15. Each cycle is a 21 days cycle
To characterize the single- and multiple-dose plasma PK of TAK-733 and alisertib in patients with advanced nonhematologic malignancies
1 secondary outcome
Measures of disease response, including objective response rate and duration of response based on investigator's assessment using RECIST guidelines
Time frame: On screening; Cycle 2: between Day 15 and 21, and every third cycle thereafter (5,8,11 etc.) until progressive disease for approximately 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 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.
1 site 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 and alisertib in people with Advanced Nonhematologic Malignancies, run by Millennium Pharmaceuticals, Inc. at 1 site 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 8 inclusion and 18 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: withdrawn, as of the sponsor's last update on 1 Nov 2013. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of Adverse Events (AEs), Serious Adverse Events (SAEs), assessments of clinical laboratory values, and vital sign measurements (time frame: From signing of the informed consent form through 30 days after the last dose of study drug). 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 1 Nov 2013.