Advanced CancerPhase 1NCT00761644
Doxil, Bevacizumab and Temsirolimus Trial
A Phase 1 study testing Doxil, Bevacizumab and Temsirolimus in people with Advanced Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn the highest safe doses of the combination of Doxil (liposomal doxorubicin), Avastin (bevacizumab), and Torisel (Temsirolimus) that can be given to patients with advanced cancer that has spread or is unable to be surgically removed. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Doxil, Bevacizumab and Temsirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2008to 28 Mar 2019
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least three months.
- All patients must have an estimated life expectancy of at least 12 weeks.
- Patients must have measurable or evaluable disease
- Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (<24 hour) half-lives and pharmacodynamic effects. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2 (Karnofsky >/= 60%).
- Patients must have organ and marrow function defined as: absolute neutrophil count >/= 1,500/mL; platelets >/=100,000/mL; creatinine </= 3 X upper limit of normal (ULN); total bilirubin </= 2.0; ALT(SGPT) </= 5 X ULN. In patients with significant liver disease and chronically elevated liver transaminases, ALT may be elevated as high as 8 X ULN.
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- Cardiac ejection fraction >/= 50% without evidence of congestive heart failure (CHF).
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies except hormonal maintenance treatment for prostate cancer.
Who cannot join
- Patients with clinically significant unexplained bleeding within 28 days prior to entering the study
- Poorly controlled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- Patients with clinically significant cardiovascular disease: - History of cerebral vascular accident (CVA) within 6 months - Myocardial infarction or unstable angina within 6 months - Unstable angina pectoris - New York Heart Association Class CHF score ≥ II
- Prior cumulative doxorubicin dose > 300 mg/m2
- Pregnant or lactating women
- History of hypersensitivity to doxil, doxorubicin, HCL, temsirolimus or it's metabolites (including sirolimus), polysorbate 80, bevacizumab or murine products
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- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Patients < 12 years of age
- Inability to swallow tablets for everolimus arm.
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 Trial of Doxil, Bevacizumab and Temsirolimus
The goal of this clinical research study is to learn the highest safe doses of the combination of Doxil (liposomal doxorubicin), Avastin (bevacizumab), and Torisel (Temsirolimus) that can be given to patients with advanced cancer that has spread or is unable to be surgically removed. The safety and effectiveness of this combination of drugs will also be studied.
Read the detailed description
The Study Drugs:
Liposomal doxorubicin is designed to cause cancer cells to be fragile, which may cause the cancer cells to die.
Bevacizumab is designed to block or slow down the growth of cancer cells by blocking the growth of blood vessels that supply nutrients for tumor growth.
Temsirolimus is designed to block the growth of cancer cells, which may eventually cause the cancer cells to die.
Everolimus is designed to block a protein called mammilian target of rapamycin (mTOR) inside the cancer cells, which is involved in cancer cell growth.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a fixed dose level of a combination of liposomal doxorubicin, bevacizumab, and either temsirolimus or everolimus, based on when you joined this study. Up to 9 dose levels of the study drug combination will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.
Study Drug Administration:
Liposomal doxorubicin, bevacizumab, and either temsirolimus or everolimus will be given in "cycles." Cycles will be about 21 days (or longer, depending on any side effects you may experience).
Liposomal doxorubicin is given by vein on Day 1 of each cycle. On Day 1 of Cycle 1, you will receive it over 3 hours. If you tolerate it well in Cycle 1, you will receive it over 60 minutes in Cycle 2. If you tolerate it well in Cycle 2, you will receive it over 60 minutes for all further cycles.
Bevacizumab is given by vein on Day 1 of each cycle. On Day 1 of Cycle 1, you will receive it over 90 minutes. If you tolerate it well in Cycle 1, you will receive it over 60 minutes in Cycle 2. If you tolerate it well in Cycle 2, you will receive it over 30 minutes in Cycle 3. It will continue to be given over 30 minutes in Cycle 4 and further cycles, as long as you still tolerate it well.
Temsirolimus is given by vein on Days 1, 8, and 15 of each cycle. During Day 1 of Cycle 1, you will receive it over 60 minutes. If you tolerate it well on Day 1 of Cycle 1, it will be given over 30 minutes on Days 8 and 15 of Cycle 1 and over 30 minutes in further cycles, as long you still tolerate it well.
Everolimus works the same way and has been shown to be as effective as temsirolimus. Everolimus can also be given by mouth, so it can be substituted for temsirolimus. Everolimus will be taken every day, starting with Day 1 of Cycle 1.
Because of a nationwide shortage of liposomal doxorubicin, you may only receive temsirolimus and bevacizumab until liposomal doxorubicin becomes available.
If you experience certain side effects, your dose level may be lowered. In some cases, your dose may be stopped for 1 week, until the side effect gets better. Your doctor can explain this to you in more detail, if it happens.
Study Visits:
During Cycle 1, you will have a physical exam once and blood will be drawn weekly (about 1 tablespoon) for routine tests.
For Cycle 2 and further cycles, you will have a physical exam and blood drawn (about 1 tablespoon) for routine tests once every 3 weeks.
The status of the disease will be checked by a CT or MRI scan after every 2 cycles, for Cycles 2-6, then every 2-3 cycles.
Additional Procedures for Some Participants:
If you are in the group that receives the highest safe dose of the study drugs, you will have the following additional procedures performed:
- You will have a biopsy performed at the end of Cycle 1. The biopsy will be used for research to see how the study drug combination acts in the body and to learn how it may affect cancer cells.
- You will have a DCE-MRI scan at 24-48 hours after your first study drug infusion (Cycle 1), and at the end of Cycle 1. These DCE-MRI scans will be used for research to see how the study drug combination is affecting blood vessels that supply nutrients and oxygen to tumor cells.
Length of Study Participation:
You may continue to receive additional cycles of the study drugs, unless the cancer goes away completely, gets worse, or if intolerable side effects occur. In that case, you will be taken off study.
Long-Term Follow-Up:
After your last dose of the study drug, you will receive up to 3 phone calls from the study staff. The calls will be 1 month apart, and you will be asked how you are doing.
This is an investigational study. Liposomal doxorubicin, bevacizumab, and temsirolimus are commercially available. Liposomal doxorubicin is FDA approved for the treatment of multiple myeloma, ovarian cancer that has returned, and Kaposi's sarcoma. Bevacizumab is FDA approved for the treatment of colorectal cancer and a type of lung cancer. Temsirolimus is FDA approved for the treatment of kidney cancer that has spread.
The combination of liposomal doxorubicin, bevacizumab, and temsirolimus is not FDA approved. At this time, it is only being used in research.
Up to 206 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Doxil, Bevacizumab, Temsirolimus
- Keywords
- Metastatic cancer, Doxil, Liposomal doxorubicin, Doxorubicin hydrochloride (liposomal), Avastin, Bevacizumab, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Torisel, Temsirolimus, CCI-779, Dynamic contrast-enhanced magnetic resonance imaging, DCE-MRI scan
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxilDrug
Also called Liposomal doxorubicin, Doxorubicin hydrocholoride (liposomal)
Day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by vein over 3 hours.
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes.
TemsirolimusDrug
Also called CCI-779, Torisel
Days 1, 8 \& 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Doxil, Bevacizumab + Temsirolimus | Experimental | Doxil day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by vein over 3 hours.
Bevacizumab day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes.
Temsirolimus days 1, 8 \& 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes. Receives: Drug: Doxil; Drug: Bevacizumab; Drug: Temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated doses (MTDs) and Dose-limiting toxicities (DLTs)
MTD defined as dose level below dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) in first cycle. Dose limiting toxicity (DLT) defined as any grade 3 or 4 non-hematologic toxicity defined in the NCI CTC v3.0, even if expected and believed related to the study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.
Measured: First cycle (21 days)
Secondary outcomes (2)
Anti-Tumor Efficacy of Drug Combination
Anti-tumor efficacy assessed by RECIST criteria.
Measured: 4 months
Anti-Tumor Efficacy of Drug Combination
Anti-tumor efficacy assessed by WHO criteria.
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 posted29 Sep 2008 (estimated)
- Study start21 Aug 2008
- Primary completion28 Mar 2019
- Study completion28 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Karp, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761644
- Sponsor's protocol ID
- 2008-0384
- Other IDs
- NCI-2012-01665
- Status last verified
- Apr 2019
- First submitted
- 25 Sep 2008
- Last updated
- 11 Apr 2019
- 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 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Doxil, Bevacizumab and Temsirolimus
- ClinicalTrials.gov ID
- NCT00761644
- Acronym / sponsor ID
- 2008-0384
- Conditions
- Advanced Cancer
- Keywords
- Metastatic cancer, Doxil, Liposomal doxorubicin, Doxorubicin hydrochloride (liposomal), Avastin, Bevacizumab, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Aug 2008 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Mar 2019 (actual)
- First posted
- 29 Sep 2008 (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 learn the highest safe doses of the combination of Doxil (liposomal doxorubicin), Avastin (bevacizumab), and Torisel (Temsirolimus) that can be given to patients with advanced cancer that has spread or is unable to be surgically removed. The safety and effectiveness of this combination of drugs will also be studied.
Detailed description
The Study Drugs:
Liposomal doxorubicin is designed to cause cancer cells to be fragile, which may cause the cancer cells to die.
Bevacizumab is designed to block or slow down the growth of cancer cells by blocking the growth of blood vessels that supply nutrients for tumor growth.
Temsirolimus is designed to block the growth of cancer cells, which may eventually cause the cancer cells to die.
Everolimus is designed to block a protein called mammilian target of rapamycin (mTOR) inside the cancer cells, which is involved in cancer cell growth.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a fixed dose level of a combination of liposomal doxorubicin, bevacizumab, and either temsirolimus or everolimus, based on when you joined this study. Up to 9 dose levels of the study drug combination will be tested. Three (3) participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.
Study Drug Administration:
Liposomal doxorubicin, bevacizumab, and either temsirolimus or everolimus will be given in "cycles." Cycles will be about 21 days (or longer, depending on any side effects you may experience).
Liposomal doxorubicin is given by vein on Day 1 of each cycle. On Day 1 of Cycle 1, you will receive it over 3 hours. If you tolerate it well in Cycle 1, you will receive it over 60 minutes in Cycle 2. If you tolerate it well in Cycle 2, you will receive it over 60 minutes for all further cycles.
Bevacizumab is given by vein on Day 1 of each cycle. On Day 1 of Cycle 1, you will receive it over 90 minutes. If you tolerate it well in Cycle 1, you will receive it over 60 minutes in Cycle 2. If you tolerate it well in Cycle 2, you will receive it over 30 minutes in Cycle 3. It will continue to be given over 30 minutes in Cycle 4 and further cycles, as long as you still tolerate it well.
Temsirolimus is given by vein on Days 1, 8, and 15 of each cycle. During Day 1 of Cycle 1, you will receive it over 60 minutes. If you tolerate it well on Day 1 of Cycle 1, it will be given over 30 minutes on Days 8 and 15 of Cycle 1 and over 30 minutes in further cycles, as long you still tolerate it well.
Everolimus works the same way and has been shown to be as effective as temsirolimus. Everolimus can also be given by mouth, so it can be substituted for temsirolimus. Everolimus will be taken every day, starting with Day 1 of Cycle 1.
Because of a nationwide shortage of liposomal doxorubicin, you may only receive temsirolimus and bevacizumab until liposomal doxorubicin becomes available.
If you experience certain side effects, your dose level may be lowered. In some cases, your dose may be stopped for 1 week, until the side effect gets better. Your doctor can explain this to you in more detail, if it happens.
Study Visits:
During Cycle 1, you will have a physical exam once and blood will be drawn weekly (about 1 tablespoon) for routine tests.
For Cycle 2 and further cycles, you will have a physical exam and blood drawn (about 1 tablespoon) for routine tests once every 3 weeks.
The status of the disease will be checked by a CT or MRI scan after every 2 cycles, for Cycles 2-6, then every 2-3 cycles.
Additional Procedures for Some Participants:
If you are in the group that receives the highest safe dose of the study drugs, you will have the following additional procedures performed:
- You will have a biopsy performed at the end of Cycle 1. The biopsy will be used for research to see how the study drug combination acts in the body and to learn how it may affect cancer cells.
- You will have a DCE-MRI scan at 24-48 hours after your first study drug infusion (Cycle 1), and at the end of Cycle 1. These DCE-MRI scans will be used for research to see how the study drug combination is affecting blood vessels that supply nutrients and oxygen to tumor cells.
Length of Study Participation:
You may continue to receive additional cycles of the study drugs, unless the cancer goes away completely, gets worse, or if intolerable side effects occur. In that case, you will be taken off study.
Long-Term Follow-Up:
After your last dose of the study drug, you will receive up to 3 phone calls from the study staff. The calls will be 1 month apart, and you will be asked how you are doing.
This is an investigational study. Liposomal doxorubicin, bevacizumab, and temsirolimus are commercially available. Liposomal doxorubicin is FDA approved for the treatment of multiple myeloma, ovarian cancer that has returned, and Kaposi's sarcoma. Bevacizumab is FDA approved for the treatment of colorectal cancer and a type of lung cancer. Temsirolimus is FDA approved for the treatment of kidney cancer that has spread.
The combination of liposomal doxorubicin, bevacizumab, and temsirolimus is not FDA approved. At this time, it is only being used in research.
Up to 206 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 |
|---|---|---|
| Doxil, Bevacizumab + Temsirolimus | Experimental | Drug: Doxil, Drug: Bevacizumab, Drug: TemsirolimusDoxil day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by vein over 3 hours. Bevacizumab day 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes. Temsirolimus days 1, 8 \& 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least three months.
- All patients must have an estimated life expectancy of at least 12 weeks.
- Patients must have measurable or evaluable disease
- Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (<24 hour) half-lives and pharmacodynamic effects. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
- Eastern Cooperative Oncology Group (ECOG) performance status </= 2 (Karnofsky >/= 60%).
Key exclusion criteria (9 listed)
- Patients with clinically significant unexplained bleeding within 28 days prior to entering the study
- Poorly controlled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg)
- Patients with clinically significant cardiovascular disease: - History of cerebral vascular accident (CVA) within 6 months - Myocardial infarction or unstable angina within 6 months - Unstable angina pectoris - New York Heart Association Class CHF score ≥ II
- Prior cumulative doxorubicin dose > 300 mg/m2
- Pregnant or lactating women
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 |
|---|---|---|
| DoxilAlso: Liposomal doxorubicin, Doxorubicin hydrocholoride (liposomal)Day 1 of each 21 day cycle, beginning dose level 10 mg/m^2 by vein over 3 hours. | Drug | Doxil, Bevacizumab + Temsirolimus |
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGFDay 1 of each 21 day cycle, beginning dose level 5 mg/kg by vein over 90 minutes. | Drug | Doxil, Bevacizumab + Temsirolimus |
| TemsirolimusAlso: CCI-779, ToriselDays 1, 8 \& 15 of 21 Day Cycle, beginning dose level 12.5 mg by vein over 30 to 60 minutes. | Drug | Doxil, Bevacizumab + Temsirolimus |
Primary outcome
Maximum tolerated doses (MTDs) and Dose-limiting toxicities (DLTs)
Time frame: First cycle (21 days)
MTD defined as dose level below dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) in first cycle. Dose limiting toxicity (DLT) defined as any grade 3 or 4 non-hematologic toxicity defined in the NCI CTC v3.0, even if expected and believed related to the study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.
2 secondary outcomes
Anti-Tumor Efficacy of Drug Combination
Time frame: 4 months
Anti-Tumor Efficacy of Drug Combination
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 Apr 2019.
- 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.
Daniel Karp, MD 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 Doxil, Bevacizumab and Temsirolimus in people with Advanced Cancer, 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 9 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 Apr 2019. 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 (MTDs) and Dose-limiting toxicities (DLTs) (time frame: First cycle (21 days)). 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 Apr 2019; AzTrials last refreshed its copy on 3 Nov 2026.