Advanced Solid TumorsPhase 1NCT01714947
Mass Balance, Pharmacokinetics and Metabolism Study of Alisertib
A Phase 1 study testing [^14C]-alisertib and alisertib in people with Advanced Solid Tumors and Lymphoma, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity [TRA] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Lymphoma
- What is being tested?
- [^14C]-alisertib and alisertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2013to 14 Jun 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 participants must meet all of the following inclusion criteria to be enrolled in the study:
- 18 years or older.
- Histologically or cytologically confirmed metastatic and/or advanced solid tumors or lymphomas for which standard curative or life-prolonging treatment does not exist, or is no longer effective or tolerable.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Expected survival longer than 3 months from enrollment in the study.
- Radiographically or clinically evaluable tumor.
Show all 10Show fewer
- Suitable venous access for the conduct of blood sampling.
- Recovered from the reversible effects of prior antineoplastic treatment (with the exception of alopecia and Grade 1 neuropathy).
- Female participants who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time.
- Male participants who agree to practice effective barrier contraception during the entire study and through 4 months after the last dose of study drug OR agree to abstain from heterosexual intercourse.
Who cannot join
- Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female participants who are lactating or have a positive serum pregnancy test.
- Treatment with any investigational products or systemic antineoplastic treatment within 21 days before the first dose of alisertib.
- Medical conditions requiring daily, chronic, or regular use of proton pump inhibitors(PPIs) within 7 days preceding the first dose of alisertib, or H2-receptor antagonists within 24 hours preceding the first dose of alisertib.
- Participants requiring systemic anticoagulation (excluding low-dose aspirin, or low-dose anticoagulation to maintain patency of venous access devices). Low molecular weight heparin, administered as preventive treatment, is allowed if the participant has tolerated treatment with a stable dose and schedule without bleeding complications for more than 1 month.
- Major surgery within the 14 days preceding the first dose of alisertib.
Show all 19Show fewer
- Infection requiring systemic intravenous (IV) antibiotic therapy within 14 days preceding the first dose of study drug, or other severe infection.
- Life-threatening or uncontrolled medical illness unrelated to cancer.
- Ongoing nausea or vomiting that is Grade 2 or worse in intensity.
- Diarrhea that is Grade 2 or worse in intensity or use of an antimotility agent to control diarrhea to an intensity of Grade 1 or lower level.
- Known GI disease or GI procedures that could interfere with the oral absorption, excretion, or tolerance of alisertib.
- History of urinary and/or fecal incontinence.
- History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease.
- Inability to swallow tablets, or inability or unwillingness to avoid taking anything by mouth except for water and prescribed medications for 2 hours before and 1 hour after the first dose of alisertib.
- Inadequate bone marrow or other organ function as specified in study protocol.
- Any cardiovascular condition specified in the study protocol.
- Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
- Inability to comply with study visits and procedures including required inpatient confinement (approximately 11-17 days).
- Please note that there are additional exclusion criteria. The study center will determine if you meet all of the criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Clinical Development
Tacoma, Washington, 98418
About this study
Official title: Mass Balance, Pharmacokinetics, and Metabolism of [^14C]-Alisertib in Patients With Advanced Solid Tumors or Lymphomas
The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity [TRA] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood.
Read the detailed description
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat participants who have advanced solid tumors or lymphomas. This study looked at mass balance, pharmacokinetics (PK), metabolism, elimination and safety of alisertib.
The study enrolled 3 patients. The study consisted of 2 parts: Part A and Part B. Participants received:
- [^14C]-alisertib 35 mg in Part A
- alisertib 50 mg in Part B
Participants were asked to take a single dose of [^14C]-alisertib oral solution containing 80-100 μCi of total radioactivity (1.19-1.48 mCi/mmol) in Part A and alisertib 50 mg, orally, twice daily for 7 days in 21-day cycles until disease progression or unacceptable toxicity in Part B.
This single center trial was conducted in United States. The overall time to participate in this study was up to 117 days. Participants remained confined to clinic in Part A and made multiple visits to the clinic in Part B. Participants were contacted 30 days after last dose of alisertib in Part A (if not continuing in Part B), or were contacted by telephone or a final visit 30 days after receiving their last dose of alisertib in Part B for a follow-up assessment.
- Conditions
- Advanced Solid Tumors, Lymphoma
- Being tested
- [^14C]-alisertib, alisertib
- Keywords
- Drug Therapy
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[^14C]-alisertibDrug
Also called MLN8237
[^14C]-alisertib oral solution
alisertibDrug
Also called MLN8237
Alisertib enteric coated tablets
| Study group | Role | What they receive |
|---|---|---|
| Alisertib | Experimental | Part A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1.
Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles). Receives: Drug: [^14C]-alisertib; Drug: alisertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Ae: Amount of [^14C]-Alisertib Excreted in Urine
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Ae: Amount of [^14C]-Alisertib Excreted in Feces
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Percent of Total Radioactivity (TRA) in Urine and Feces
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Fe: Fraction of Administered Dose of Alisertib Excreted in Urine
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Ae: Amount of Alisertib Excretion in Urine
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Renal Clearance (CLR) of Alisertib
Measured: Predose and multiple timepoints post-dose (up to 240 hours)
Secondary outcomes (6)
Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
Total radioactive peak distributions of metabolites in 0 to 192 hours pooled plasma samples from participants.
Measured: Predose and multiple timepoints post-dose (0 to 192 hours)
Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution
Total radioactive peak distributions of metabolites in 0 to 192 hours pooled urine samples from participants.
Measured: Predose and multiple timepoints post-dose (0 to 192 hours)
Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution
Total radioactive peak distributions of metabolites in 0 to 192 hours pooled fecal samples from participants.
Measured: Predose and multiple timepoints post-dose (0 to 192 hours)
Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) was defined as any AE at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity or resulted in congenital anomaly/birth defect. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days)
Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs
An abnormal laboratory was assessed to be an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from Baseline.
Measured: Part A: Day 1 and End of Study (EOS) Day 31 if not continuing to Part B, Part B: Days 8 and 15 of each cycle and EOS (Up to 117 days)
Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements
Vital signs included body temperature, heart rate, and sitting blood pressure. The investigator determined if the changes were clinically significant.
Measured: Part A: Day 1 and EOS (Day 31 if not continuing to Part B), Part B: Day 1 of each cycle and EOS (Up to 117 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study start24 Jan 2013
- Primary completion4 Apr 2013
- Study completion14 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorsStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714947
- Sponsor's protocol ID
- C14014
- Other IDs
- U1111-1187-6760
- Status last verified
- Feb 2018
- First submitted
- 17 Oct 2012
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mass Balance, Pharmacokinetics, and Metabolism of [^14C]-Alisertib in Patients With Advanced Solid Tumors or Lymphomas
- ClinicalTrials.gov ID
- NCT01714947
- Acronym / sponsor ID
- C14014
- Conditions
- Advanced Solid Tumors, Lymphoma
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Jan 2013 (actual)
- Primary completion
- 4 Apr 2013 (actual)
- Study completion
- 14 Jun 2013 (actual)
- First posted
- 26 Oct 2012 (estimated)
- Results
- Posted 31 Oct 2018
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 assess the mass balance (i.e. cumulative excretion of total radioactivity [TRA] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood.
Detailed description
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat participants who have advanced solid tumors or lymphomas. This study looked at mass balance, pharmacokinetics (PK), metabolism, elimination and safety of alisertib.
The study enrolled 3 patients. The study consisted of 2 parts: Part A and Part B. Participants received:
- [^14C]-alisertib 35 mg in Part A
- alisertib 50 mg in Part B
Participants were asked to take a single dose of [^14C]-alisertib oral solution containing 80-100 μCi of total radioactivity (1.19-1.48 mCi/mmol) in Part A and alisertib 50 mg, orally, twice daily for 7 days in 21-day cycles until disease progression or unacceptable toxicity in Part B.
This single center trial was conducted in United States. The overall time to participate in this study was up to 117 days. Participants remained confined to clinic in Part A and made multiple visits to the clinic in Part B. Participants were contacted 30 days after last dose of alisertib in Part A (if not continuing in Part B), or were contacted by telephone or a final visit 30 days after receiving their last dose of alisertib in Part B for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alisertib | Experimental | Drug: [^14C]-alisertib, Drug: alisertibPart A: [^14C]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1. Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Each participants must meet all of the following inclusion criteria to be enrolled in the study:
- 18 years or older.
- Histologically or cytologically confirmed metastatic and/or advanced solid tumors or lymphomas for which standard curative or life-prolonging treatment does not exist, or is no longer effective or tolerable.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Expected survival longer than 3 months from enrollment in the study.
Key exclusion criteria (19 listed)
- Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
- Female participants who are lactating or have a positive serum pregnancy test.
- Treatment with any investigational products or systemic antineoplastic treatment within 21 days before the first dose of alisertib.
- Medical conditions requiring daily, chronic, or regular use of proton pump inhibitors(PPIs) within 7 days preceding the first dose of alisertib, or H2-receptor antagonists within 24 hours preceding the first dose of alisertib.
- Participants requiring systemic anticoagulation (excluding low-dose aspirin, or low-dose anticoagulation to maintain patency of venous access devices). Low molecular weight heparin, administered as preventive treatment, is allowed if the participant has tolerated treatment with a stable dose and schedule without bleeding complications for more than 1 month.
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 |
|---|---|---|
| [^14C]-alisertibAlso: MLN8237[^14C]-alisertib oral solution | Drug | Alisertib |
| alisertibAlso: MLN8237Alisertib enteric coated tablets | Drug | Alisertib |
Primary outcome
Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Ae: Amount of [^14C]-Alisertib Excreted in Urine
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Ae: Amount of [^14C]-Alisertib Excreted in Feces
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Percent of Total Radioactivity (TRA) in Urine and Feces
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Fe: Fraction of Administered Dose of Alisertib Excreted in Urine
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Ae: Amount of Alisertib Excretion in Urine
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
Renal Clearance (CLR) of Alisertib
Time frame: Predose and multiple timepoints post-dose (up to 240 hours)
6 secondary outcomes
Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame: Predose and multiple timepoints post-dose (0 to 192 hours)
Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame: Predose and multiple timepoints post-dose (0 to 192 hours)
Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution
Time frame: Predose and multiple timepoints post-dose (0 to 192 hours)
Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days)
Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs
Time frame: Part A: Day 1 and End of Study (EOS) Day 31 if not continuing to Part B, Part B: Days 8 and 15 of each cycle and EOS (Up to 117 days)
Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements
Time frame: Part A: Day 1 and EOS (Day 31 if not continuing to Part B), Part B: Day 1 of each cycle and EOS (Up to 117 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Director Clinical Science study director
Takeda
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 [^14C]-alisertib and alisertib in people with Advanced Solid Tumors and Lymphoma, 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 10 inclusion and 19 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 31 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 31 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution (time frame: Predose and multiple timepoints post-dose (up to 240 hours)). The study lists 20 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 Oct 2018.