Advanced CancersPhase 1NCT02042989
MLN9708 and Vorinostat in Patients With Advanced p53 Mutant Malignancies
A Phase 1 study testing MLN9708 and Vorinostat in people with Advanced Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of MLN9708 and vorinostat that can be given to patients with advanced solid tumors. The safety of these drugs will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- MLN9708 and Vorinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2014to 22 Jan 2020
- 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.
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Female patients who: • Are postmenopausal for at least 1 year before the screening visit, OR • Are surgically sterile, OR • If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: • Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Patients must have a diagnosis with solid tumors and lymphomas, either refractory to standard therapy or for which no effective standard therapy that conveys clinical benefit.
- Patients must have a p53 mutation which is defined as cytoplasmic positivity by immunohistochemistry and/or next gene mutation sequencing.
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- Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2.
- Patients must meet the following clinical laboratory criteria:Absolute neutrophil count (ANC) >/= 1,000/mm^3 and platelet count >/= 75,000/mm^3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.Total bilirubin </= 1.5 x the upper limit of the normal range (ULN).Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= 3 x ULN.Calculated creatinine clearance >/= 30 mL/min.
- Patients may receive local palliative radiation therapy immediately before or during the treatment if the radiation therapy is not delivered to the sole target lesions.
- Measurable or evaluable disease will be included as assessed by RECIST 1.1.
Who cannot join
- Female patients who are lactating or have a positive blood pregnancy test during the screening period.
- Failure to have fully recovered (ie, </= Grade 1 toxicity) from the reversible effects of prior chemotherapy.
- Major surgery within 14 days before first dose of study drug..
- Radiotherapy within 14 days before first dose of study drug. If the involved field is small, 7 days will be considered a sufficient interval between treatment and study initiation.
- Active uncontrolled central nervous system involvement.
- Infection requiring systemic antibiotic therapy or other serious infection within 14 days before first dose of study drug.
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- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
- Systemic treatment, within 14 days before the first dose of MLN9708, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort.
- Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of MLN9708 including difficulty swallowing.
- Diagnosed or treated for another malignancy within 2 years before first dose of study drug. or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Patient has >/= Grade 2 peripheral neuropathy
- Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21days of the start of this trial and throughout the duration of this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Study of MLN9708 and Vorinostat to Target Autophagy in Patients With Advanced p53 Mutant Malignancies
The goal of this clinical research study is to find the highest tolerable dose of the combination of MLN9708 and vorinostat that can be given to patients with advanced solid tumors. The safety of these drugs will also be studied.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of MLN9708 and vorinostat based on when you join this study. Up to 4 dose levels of the MLN9708 and vorinostat combination will be tested. Up to 6 participants will be enrolled at each dose level combination. The first group of participants will receive the lowest dose level combination. Each new group will receive a higher dose of either MLN9708 or vorinostat than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose combination of MLN9708 and vorinostat is found or all 4 dose levels are filled. Up to an additional 14 participants will be enrolled in the highest dose level of the study drug combination.
The dose of the study drug combination that you receive may be lowered if you have intolerable side effects.
Study Drug Administration:
Each study cycle is 28 days.
You will take MLN9708 capsules by mouth every 7 days (on Days 1, 8, and 15 of every cycle). You should swallow MLN9708 capsules whole with 8 ounces (1 cup) of water. Each capsule should be swallowed separately with a sip of water. Do not break, chew, or open the capsules. Each dose should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal. If you miss a dose, take it as soon as you remember, as long as the next scheduled dose is at least 72 hours (3 days) away. You should not take a double dose to make up for a missed dose. If you vomit after taking a dose, wait until the next scheduled dose. Do not take an additional dose.
You will take vorinostat capsules by mouth on Days 1-21 of each cycle, followed by a break of 7 days. You should swallow vorinostat capsules whole with water. Do not break, chew, or open the capsules. Vorinostat should be taken with food. If you miss a dose, take it as soon as you remember, as long as the next scheduled dose is at least 12 hours away. You should not take a double dose to make up for a missed dose. If you vomit after taking a dose, wait until the next scheduled dose. Do not take an additional dose.
It is important that you tell your doctor if you have any side effects while on this study. If you have side effects or abnormal test results, you may be asked to return to the clinic for more tests until the side effects or abnormal test results improve. Your dose of study drug may be changed and/or you may be given drugs to help control the side effects.
Study Visits:
One (1) time each week during Cycle 1:
° Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function.
On Day 1 of Cycles 2 and beyond:
- You will have a physical exam.
- Blood (about 6 teaspoons) will be drawn for routine tests.
- If your doctor thinks it is needed, urine will be collected for routine tests.
At the end of Cycles 2 and beyond:
- You will have a CT, PET, and/or MRI scan to check the status of the disease. If your doctor thinks it is needed, you may have measurement sooner.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers. Tumor markers can be used to check the status of the disease.
Any time the doctor thinks it is needed:
- Blood (about 6 teaspoons) will be drawn for routine tests.
- If you can become pregnant, blood (about 1 teaspoon) will be collected for a pregnancy test.
- You will have an EKG to check your heart function.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if you develop new health problems, or if you are no longer able to follow study directions.
You may choose to stop taking the study drugs at any time. You should tell the study doctor right away if you are thinking about no longer taking part in this study. The study doctor will talk to you about how to safely stop taking the study drugs.
Your participation on the study will be over after the end-of-study visit.
End of Study Visit:
Within 30 days after your last dose of the study drugs, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 7 teaspoons) will be drawn for routine tests, tests of your kidney and liver function, and tumor marker testing.
- You will have a CT, PET, and/or MRI scan to check the status of the disease. If your doctor thinks it is needed, you may have a scan performed sooner.
This is an investigational study. MLN9708 is not FDA approved or commercially available. MLN9708 is currently being used for research purposes only. Vorinostat is FDA approved and commercially available to treat advanced cutaneous T-cell lymphoma.
The study doctor can explain how the study drugs are designed to work.
Up to 56 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancers
- Being tested
- MLN9708, Vorinostat
- Keywords
- Advanced Cancers, Advanced solid tumor, Advanced p53 Mutant Malignancies, MLN9708, Vorinostat, SAHA, Suberoylanilide Hydroxamic Acid, MSK-390, Zolinza
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN9708Drug
Dose Escalation Phase - Starting Dose of MLN9708: 3 mg by mouth on day 1, 8 and 15.
Dose Expansion Phase Starting Dose of MLN9708: Maximum tolerated dose from Dose Escalation Phase.
VorinostatDrug
Also called SAHA, Suberoylanilide Hydroxamic Acid, MSK-390, Zolinza
Dose Escalation Phase - Starting Dose of Vorinostat: 100 mg by mouth twice a day, total of 200 mg/day Days 1 to 21.
Dose Expansion Phase Starting Dose of Vorinostat: Maximum tolerated dose from Dose Escalation Phase.
| Study group | Role | What they receive |
|---|---|---|
| MLN9708 and Vorinostat | Experimental | Dose Escalation Phase: Starting Dose of MLN9708 3 mg by mouth on day 1, 8 and 15. Starting Dose of Vorinostat: 100 mg by mouth twice a day, total of 200 mg/day Days 1 to 21.
Dose Expansion Phase Starting Doses of MLN9708 and Vorinostat: Maximum tolerated dose from Dose Escalation Phase. Receives: Drug: MLN9708; Drug: Vorinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Doses (MTD) of MLN9708 and Vorinostat
Maximum tolerated dose is the highest dose level in which 6 patients have been treated with at most 1 experiencing dose limiting toxicity (DLT). Dose-limiting toxicity defined if the events occur within the first cycle (28 days).
Measured: After 2, 28 day cycles
Secondary outcomes (1)
Tumor Response
Tumor response defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by RECIST criteria, (3) decrease in tumor markers by more than or equal to 25% (for example, a ≥ 25% decrease in CA125 for patients with ovarian cancer), or (4) a partial response according to the Choi criteria96-98, i.e. decrease in size by 10% or more, or a decrease in tumor density, as measured by Hounsfield units (HU), by more than or equal to 15%.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start27 Jun 2014
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancersStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Siqing Fu, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042989
- Sponsor's protocol ID
- 2013-0511
- Other IDs
- NCI-2014-01091
- Status last verified
- Jul 2022
- First submitted
- 21 Jan 2014
- Last updated
- 11 Jul 2022
- Results posted
- No
- 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 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of MLN9708 and Vorinostat to Target Autophagy in Patients With Advanced p53 Mutant Malignancies
- ClinicalTrials.gov ID
- NCT02042989
- Acronym / sponsor ID
- 2013-0511
- Conditions
- Advanced Cancers
- Keywords
- Advanced Cancers, Advanced solid tumor, Advanced p53 Mutant Malignancies, MLN9708, Vorinostat, SAHA, Suberoylanilide Hydroxamic Acid, MSK-390
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- 27 Jun 2014 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 23 Jan 2014 (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 goal of this clinical research study is to find the highest tolerable dose of the combination of MLN9708 and vorinostat that can be given to patients with advanced solid tumors. The safety of these drugs will also be studied.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of MLN9708 and vorinostat based on when you join this study. Up to 4 dose levels of the MLN9708 and vorinostat combination will be tested. Up to 6 participants will be enrolled at each dose level combination. The first group of participants will receive the lowest dose level combination. Each new group will receive a higher dose of either MLN9708 or vorinostat than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose combination of MLN9708 and vorinostat is found or all 4 dose levels are filled. Up to an additional 14 participants will be enrolled in the highest dose level of the study drug combination.
The dose of the study drug combination that you receive may be lowered if you have intolerable side effects.
Study Drug Administration:
Each study cycle is 28 days.
You will take MLN9708 capsules by mouth every 7 days (on Days 1, 8, and 15 of every cycle). You should swallow MLN9708 capsules whole with 8 ounces (1 cup) of water. Each capsule should be swallowed separately with a sip of water. Do not break, chew, or open the capsules. Each dose should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal. If you miss a dose, take it as soon as you remember, as long as the next scheduled dose is at least 72 hours (3 days) away. You should not take a double dose to make up for a missed dose. If you vomit after taking a dose, wait until the next scheduled dose. Do not take an additional dose.
You will take vorinostat capsules by mouth on Days 1-21 of each cycle, followed by a break of 7 days. You should swallow vorinostat capsules whole with water. Do not break, chew, or open the capsules. Vorinostat should be taken with food. If you miss a dose, take it as soon as you remember, as long as the next scheduled dose is at least 12 hours away. You should not take a double dose to make up for a missed dose. If you vomit after taking a dose, wait until the next scheduled dose. Do not take an additional dose.
It is important that you tell your doctor if you have any side effects while on this study. If you have side effects or abnormal test results, you may be asked to return to the clinic for more tests until the side effects or abnormal test results improve. Your dose of study drug may be changed and/or you may be given drugs to help control the side effects.
Study Visits:
One (1) time each week during Cycle 1:
° Blood (about 6 teaspoons) will be drawn for routine tests and to check your liver and kidney function.
On Day 1 of Cycles 2 and beyond:
- You will have a physical exam.
- Blood (about 6 teaspoons) will be drawn for routine tests.
- If your doctor thinks it is needed, urine will be collected for routine tests.
At the end of Cycles 2 and beyond:
- You will have a CT, PET, and/or MRI scan to check the status of the disease. If your doctor thinks it is needed, you may have measurement sooner.
- If the study doctor thinks it is needed, blood (about 1 teaspoon) will be drawn to measure tumor markers. Tumor markers can be used to check the status of the disease.
Any time the doctor thinks it is needed:
- Blood (about 6 teaspoons) will be drawn for routine tests.
- If you can become pregnant, blood (about 1 teaspoon) will be collected for a pregnancy test.
- You will have an EKG to check your heart function.
Length of Study:
You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if you develop new health problems, or if you are no longer able to follow study directions.
You may choose to stop taking the study drugs at any time. You should tell the study doctor right away if you are thinking about no longer taking part in this study. The study doctor will talk to you about how to safely stop taking the study drugs.
Your participation on the study will be over after the end-of-study visit.
End of Study Visit:
Within 30 days after your last dose of the study drugs, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 7 teaspoons) will be drawn for routine tests, tests of your kidney and liver function, and tumor marker testing.
- You will have a CT, PET, and/or MRI scan to check the status of the disease. If your doctor thinks it is needed, you may have a scan performed sooner.
This is an investigational study. MLN9708 is not FDA approved or commercially available. MLN9708 is currently being used for research purposes only. Vorinostat is FDA approved and commercially available to treat advanced cutaneous T-cell lymphoma.
The study doctor can explain how the study drugs are designed to work.
Up to 56 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MLN9708 and Vorinostat | Experimental | Drug: MLN9708, Drug: VorinostatDose Escalation Phase: Starting Dose of MLN9708 3 mg by mouth on day 1, 8 and 15. Starting Dose of Vorinostat: 100 mg by mouth twice a day, total of 200 mg/day Days 1 to 21. Dose Expansion Phase Starting Doses of MLN9708 and Vorinostat: Maximum tolerated dose from Dose Escalation Phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients 18 years or older.
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Female patients who: • Are postmenopausal for at least 1 year before the screening visit, OR • Are surgically sterile, OR • If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree to one of the following: • Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Patients must have a diagnosis with solid tumors and lymphomas, either refractory to standard therapy or for which no effective standard therapy that conveys clinical benefit.
Key exclusion criteria (15 listed)
- Female patients who are lactating or have a positive blood pregnancy test during the screening period.
- Failure to have fully recovered (ie, </= Grade 1 toxicity) from the reversible effects of prior chemotherapy.
- Major surgery within 14 days before first dose of study drug..
- Radiotherapy within 14 days before first dose of study drug. If the involved field is small, 7 days will be considered a sufficient interval between treatment and study initiation.
- Active uncontrolled central nervous system involvement.
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 |
|---|---|---|
| MLN9708Dose Escalation Phase - Starting Dose of MLN9708: 3 mg by mouth on day 1, 8 and 15. Dose Expansion Phase Starting Dose of MLN9708: Maximum tolerated dose from Dose Escalation Phase. | Drug | MLN9708 and Vorinostat |
| VorinostatAlso: SAHA, Suberoylanilide Hydroxamic Acid, MSK-390, ZolinzaDose Escalation Phase - Starting Dose of Vorinostat: 100 mg by mouth twice a day, total of 200 mg/day Days 1 to 21. Dose Expansion Phase Starting Dose of Vorinostat: Maximum tolerated dose from Dose Escalation Phase. | Drug | MLN9708 and Vorinostat |
Primary outcome
Maximum Tolerated Doses (MTD) of MLN9708 and Vorinostat
Time frame: After 2, 28 day cycles
Maximum tolerated dose is the highest dose level in which 6 patients have been treated with at most 1 experiencing dose limiting toxicity (DLT). Dose-limiting toxicity defined if the events occur within the first cycle (28 days).
1 secondary outcome
Tumor Response
Time frame: 4 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 11 Jul 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Siqing Fu, MD,PHD principal investigator
M.D. Anderson Cancer Center
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 MLN9708 and Vorinostat in people with Advanced Cancers, run by M.D. Anderson Cancer Center 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 15 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 11 Jul 2022. 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 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?
Maximum Tolerated Doses (MTD) of MLN9708 and Vorinostat (time frame: After 2, 28 day cycles). 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 11 Jul 2022.