Advanced CancerPhase 1NCT01015222
Dasatinib, Bevacizumab, Paclitaxel in Patients With Advanced Malignancies
A Phase 1 study testing Dasatinib, Bevacizumab and Paclitaxel 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 find the highest tolerable dose of the combination of dasatinib, bevacizumab, and paclitaxel with or without Methylnaltrexone that can be given to patients with advanced cancer. The safety of this drug combination will also be studied. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Dasatinib, Bevacizumab and Paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to 27 May 2021
- 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 Any age
- 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 who have no standard therapy available that improves survival by at least three months.
- Patients must be >/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment providing radiation is not delivered to the only site of disease being treated under this protocol. After targeted/biologic therapy a patient has to be off treatment for 5 half-lives or 3 weeks whatever is shorter.
- ECOG performance status </= 2.
- Patients must have normal organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=90,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 5 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 8 X ULN.
- 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 30 days after the last dose.
- Patients must be able to understand and be willing to sign a written informed consent document.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
- Patients with hemoptysis within 28 days prior to entering the study.
- Patients with clinically significant unexplained bleeding within 28 days prior to the first dose of study medication.
- Uncontrolled systemic vascular hypertension (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg on medication).
- Patients with clinically significant cardiovascular disease: history of CVA within 6 months; myocardial infarction or unstable angina within 6 months.
- Major surgery within 28 days prior to Day 1 of dosing Bevacizumab.
Show all 14Show fewer
- Pregnant or lactating women.
- History of hypersensitivity to dasatinib or any component of the formulation.
- History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
- History of hypersensitivity to paclitaxel or any component of the formulation.
- Patients with pleural effusion which is considered clinically significant by the attending physician.
- Patients unwilling or unable to sign informed consent document.
- Social situations that would limit compliance with study requirements.
- Patients receiving opioids within 2 weeks before signing the consent and patients, who cannot be off opioids until initiating the study medication (for methylnaltrexone arm only).
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 Dasatinib (Src Inhibitor), Bevacizumab (Anti-VEGF Monoclonal Antibody) and Metronomic Paclitaxel + or - Methylnaltrexone in Patients With Advanced Malignancies
The goal of this clinical research study is to find the highest tolerable dose of the combination of dasatinib, bevacizumab, and paclitaxel with or without Methylnaltrexone that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
Read the detailed description
The Study Drugs:
Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells. This may cause the tumor cells to die.
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells.
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
Methylnaltrexone is designed to block the constipating effect of opioid analgesics on the gastrointestinal tract. It is also capable of blocking the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells.
Study Groups:
Dose escalation:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of dasatinib, bevacizumab, and paclitaxel based on when you join this study. Up to 8 dose levels of dasatinib, bevacizumab, and paclitaxel will be tested. Three (3) to 9 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 combination of dasatinib, bevacizumab, and paclitaxel is found.
The highest tolerable dose of the combination of dasatinib, bevacizumab, and paclitaxel that was found will be given in combination with methylnaltrexone to up to 6 participants. If intolerable side effects occur, the next group of up to 6 participants will receive a lower dose of methylnaltrexone but the same dose of the combination of dasatinib, bevacizumab, and paclitaxel.
Dose expansion:
Once the highest safe dose of the combinations of dasatinib, bevacizumab, and paclitaxel with and without methylnaltrexone are found, 14 additional participants will be enrolled and receive the study drugs at each dose level combination. Participants with a tumor type (14 for each tumor type) that have responded to the study drug combination will receive the study drugs at that dose level, as well.
Study Drug Administration:
Each study "cycle" is 28 days.
Everyday, you will take dasatinib by mouth 1 time a day. You should take it at about the same time each day with food and a cup of water (about 8 ounces).
On Days 1 and 15 of each cycle, you will receive bevacizumab by vein over 90 minutes. If the first dose is well tolerated, you will receive the next dose over 60 minutes. If the second dose is well tolerated, you will receive the next doses over 30 minutes.
On Days 1, 8, and 15 of each cycle, you will receive paclitaxel by vein over 60 minutes. On Days 1 and 15, your paclitaxel dose will be given after your bevacizumab dose.
About 30 minutes before each scheduled dose of paclitaxel, you will also receive medications (such as dexamethasone) to lower the likelihood of experiencing allergic reactions.
If you receive methylnaltrexone, you will receive it by injection under the skin either to the upper arm, upper thigh, or stomach at the same time 2 times every day. The study doctor or nurse will teach you how to give the injections yourself.
Study Visits:
At every study visit, you will be asked about any current health conditions you have, drugs you may be taking, and if you have experienced any side effects.
Around Days 8 and 28 of Cycle 1:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Around Day 15 of Cycle 1, blood (about 2 teaspoons) will be drawn for routine tests.
Around Day 28 of Cycles 2 and beyond:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Every 4 weeks, you will have a blood (about 1 teaspoon) drawn or urine collected for pregnancy test if you are able to become pregnant.
Every 8 weeks, you will have an x-ray, CT scan, MRI scan, and/or PET/CT scan to check the status of the disease. If the study doctor thinks it is needed, they will be performed more often.
Length of Study:
You may stay on study for as long as the disease does not get worse, you have not experienced intolerable side effects, and if the study doctor thinks it is in your best interest.
End-of-Study Visit:
About 28 days after the last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests or procedures may be performed:
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have an x-ray, CT scan, MRI scan, and/or PET/CT scan to check the status of the disease.
This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of chronic myeloid leukemia. Bevacizumab is FDA approved and commercially available for the treatment of colorectal, breast, lung, and brain cancer. Paclitaxel is FDA approved and commercially available for the treatment of breast, lung, and ovarian cancer and Kaposi's sarcoma. Methylnaltrexone is FDA approved and commercially available for the treatment of constipation in patients with advanced illness who are receiving palliative care. The combination of these drugs when given to patients with advanced cancer is investigational.
Up to 218 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Advanced Cancer
- Being tested
- Dasatinib, Bevacizumab, Paclitaxel
- Keywords
- Advanced Malignancies, Metastatic cancer, Bevacizumab, Avastin, Dasatinib, Sprycel, Paclitaxel, Taxol
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called BMS-354825, Sprycel
Starting dose of 50 mg daily PO for 28 day cycle
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Starting dose 5 mg/kg IV Day 1 and 15
PaclitaxelDrug
Also called Taxol
Starting dose 40 mg/m2 IV Day 1, 8 and 15
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib, Bevacizumab + Paclitaxel | Experimental | Dose Escalation Starting Dose Levels: 50 mg Dasatinib daily by mouth (PO), 5 mg/kg Bevacizumab IV on Day 1 and 15; Paclitaxel 40 mg/m2 IV on Day 1, 8 and 15
Dose Expansion Starting Dose Levels: Maximum tolerated dose from Dose Escalation. Receives: Drug: Dasatinib; Drug: Bevacizumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment
MTD defined as the highest dose below any dose that has one third or more patients with dose limiting toxicities (DLT).
Measured: Continuous assessment during each dose level/28-day cycle
Secondary outcomes (1)
Antitumor Efficacy of the Combination of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment
Participants with lymphoma measured per the WHO criteria, and all others evaluated using RECIST criteria version 1.1.
Measured: 28 days after the last dose of study drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completion27 May 2021
- Study completion27 May 2021
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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip Janku, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015222
- Sponsor's protocol ID
- 2009-0521
- Other IDs
- NCI-2012-01274
- Status last verified
- Nov 2022
- First submitted
- 17 Nov 2009
- Last updated
- 23 Nov 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 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Dasatinib (Src Inhibitor), Bevacizumab (Anti-VEGF Monoclonal Antibody) and Metronomic Paclitaxel + or - Methylnaltrexone in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT01015222
- Acronym / sponsor ID
- 2009-0521
- Conditions
- Advanced Cancer
- Keywords
- Advanced Malignancies, Metastatic cancer, Bevacizumab, Avastin, Dasatinib, Sprycel, Paclitaxel, Taxol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 18 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find the highest tolerable dose of the combination of dasatinib, bevacizumab, and paclitaxel with or without Methylnaltrexone that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
Detailed description
The Study Drugs:
Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells. This may cause the tumor cells to die.
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells.
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
Methylnaltrexone is designed to block the constipating effect of opioid analgesics on the gastrointestinal tract. It is also capable of blocking the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells.
Study Groups:
Dose escalation:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of dasatinib, bevacizumab, and paclitaxel based on when you join this study. Up to 8 dose levels of dasatinib, bevacizumab, and paclitaxel will be tested. Three (3) to 9 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 combination of dasatinib, bevacizumab, and paclitaxel is found.
The highest tolerable dose of the combination of dasatinib, bevacizumab, and paclitaxel that was found will be given in combination with methylnaltrexone to up to 6 participants. If intolerable side effects occur, the next group of up to 6 participants will receive a lower dose of methylnaltrexone but the same dose of the combination of dasatinib, bevacizumab, and paclitaxel.
Dose expansion:
Once the highest safe dose of the combinations of dasatinib, bevacizumab, and paclitaxel with and without methylnaltrexone are found, 14 additional participants will be enrolled and receive the study drugs at each dose level combination. Participants with a tumor type (14 for each tumor type) that have responded to the study drug combination will receive the study drugs at that dose level, as well.
Study Drug Administration:
Each study "cycle" is 28 days.
Everyday, you will take dasatinib by mouth 1 time a day. You should take it at about the same time each day with food and a cup of water (about 8 ounces).
On Days 1 and 15 of each cycle, you will receive bevacizumab by vein over 90 minutes. If the first dose is well tolerated, you will receive the next dose over 60 minutes. If the second dose is well tolerated, you will receive the next doses over 30 minutes.
On Days 1, 8, and 15 of each cycle, you will receive paclitaxel by vein over 60 minutes. On Days 1 and 15, your paclitaxel dose will be given after your bevacizumab dose.
About 30 minutes before each scheduled dose of paclitaxel, you will also receive medications (such as dexamethasone) to lower the likelihood of experiencing allergic reactions.
If you receive methylnaltrexone, you will receive it by injection under the skin either to the upper arm, upper thigh, or stomach at the same time 2 times every day. The study doctor or nurse will teach you how to give the injections yourself.
Study Visits:
At every study visit, you will be asked about any current health conditions you have, drugs you may be taking, and if you have experienced any side effects.
Around Days 8 and 28 of Cycle 1:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Around Day 15 of Cycle 1, blood (about 2 teaspoons) will be drawn for routine tests.
Around Day 28 of Cycles 2 and beyond:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Every 4 weeks, you will have a blood (about 1 teaspoon) drawn or urine collected for pregnancy test if you are able to become pregnant.
Every 8 weeks, you will have an x-ray, CT scan, MRI scan, and/or PET/CT scan to check the status of the disease. If the study doctor thinks it is needed, they will be performed more often.
Length of Study:
You may stay on study for as long as the disease does not get worse, you have not experienced intolerable side effects, and if the study doctor thinks it is in your best interest.
End-of-Study Visit:
About 28 days after the last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests or procedures may be performed:
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have an x-ray, CT scan, MRI scan, and/or PET/CT scan to check the status of the disease.
This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of chronic myeloid leukemia. Bevacizumab is FDA approved and commercially available for the treatment of colorectal, breast, lung, and brain cancer. Paclitaxel is FDA approved and commercially available for the treatment of breast, lung, and ovarian cancer and Kaposi's sarcoma. Methylnaltrexone is FDA approved and commercially available for the treatment of constipation in patients with advanced illness who are receiving palliative care. The combination of these drugs when given to patients with advanced cancer is investigational.
Up to 218 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 |
|---|---|---|
| Dasatinib, Bevacizumab + Paclitaxel | Experimental | Drug: Dasatinib, Drug: Bevacizumab, Drug: PaclitaxelDose Escalation Starting Dose Levels: 50 mg Dasatinib daily by mouth (PO), 5 mg/kg Bevacizumab IV on Day 1 and 15; Paclitaxel 40 mg/m2 IV on Day 1, 8 and 15 Dose Expansion Starting Dose Levels: Maximum tolerated dose from Dose Escalation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
- Patients must be >/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment providing radiation is not delivered to the only site of disease being treated under this protocol. After targeted/biologic therapy a patient has to be off treatment for 5 half-lives or 3 weeks whatever is shorter.
- ECOG performance status </= 2.
- Patients must have normal organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=90,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 5 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 8 X ULN.
- 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 30 days after the last dose.
Key exclusion criteria (14 listed)
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
- Patients with hemoptysis within 28 days prior to entering the study.
- Patients with clinically significant unexplained bleeding within 28 days prior to the first dose of study medication.
- Uncontrolled systemic vascular hypertension (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg on medication).
- Patients with clinically significant cardiovascular disease: history of CVA within 6 months; myocardial infarction or unstable angina within 6 months.
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 |
|---|---|---|
| DasatinibAlso: BMS-354825, SprycelStarting dose of 50 mg daily PO for 28 day cycle | Drug | Dasatinib, Bevacizumab + Paclitaxel |
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGFStarting dose 5 mg/kg IV Day 1 and 15 | Drug | Dasatinib, Bevacizumab + Paclitaxel |
| PaclitaxelAlso: TaxolStarting dose 40 mg/m2 IV Day 1, 8 and 15 | Drug | Dasatinib, Bevacizumab + Paclitaxel |
Primary outcome
Maximum Tolerated Dose (MTD) of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment
Time frame: Continuous assessment during each dose level/28-day cycle
MTD defined as the highest dose below any dose that has one third or more patients with dose limiting toxicities (DLT).
1 secondary outcome
Antitumor Efficacy of the Combination of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment
Time frame: 28 days after the last dose of study drugs
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 23 Nov 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
Filip Janku, 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 Dasatinib, Bevacizumab and Paclitaxel 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 6 inclusion and 14 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 23 Nov 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 Dose (MTD) of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone in Advanced or Metastatic Cancer That is Refractory to Standard Treatment (time frame: Continuous assessment during each dose level/28-day cycle). 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 23 Nov 2022.