Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT00566618
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2007-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase I/II Study of Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of dasatinib and Zometa (zoledronic acid) that can be given in combination for the treatment of breast cancer that has spread to the bone. The safety and effectiveness of this combination will also be studied.
Detailed Description:
The Study Drugs:
Zoledronic acid is designed to strengthen the bone and prevent fractures or breaks in the bone. Dasatinib is designed to block (stop) cells responsible for the breakdown of bone.
Study Groups:
If you are found to be eligible to take part in this study, you will be enrolled in a group of at least 3 participants to begin receiving zoledronic acid and dasatinib. The dose of dasatinib you receive will depend on when you enrolled in this study. All participants will receive the same amount of zoledronic acid. The first group of participants will be treated with the lowest dose of dasatinib given in combination with zoledronic acid.
Once the highest tolerable dose level is found, up to 25 additional participants will be enrolled at that dose level. This is called the Phase II portion of the study.
Drug Administration:
You will receive zoledronic acid through a needle in your vein on Day 1 over 15 minutes. You will take dasatinib by mouth daily for 28 days. Dasatinib should be taken on an empty stomach or after a light meal. Every 28 days is called a study "cycle."
Study Visits for Participants in the Phase I Portion:
On Day 1 of Cycle 1, you will have the following tests and procedures performed.
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have an ECG.
On Day 8 of Cycle 1, you will have the following tests and procedures performed.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have an ECG.
On Day 15 of Cycle 1, you will have the following tests and procedures performed.
* You will have a physical exam.
* You will have a performance status evaluation.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have an ECG.
On Day 21 of Cycle 1, you will have the following tests and procedures performed.
* Your vital signs will be measured.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have an ECG.
On Day 1 of Cycle 2, you will have an ECG.
On Day 1 of all other cycles, you will have the following tests and procedures performed.
* You will have a physical exam.
* You will have a performance status evaluation.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have MRIs, CT scans, and/or x-rays to check the status of the disease.
On Days 1 and 28 of Cycle 1 and then every 3rd month, urine will be collected over 24 hours to check for markers of bone loss.
After Cycles 3, 6, 9 and so on, you will have CT scans, MRIs, and/or x-rays to check the status of the disease
At all study visits, you will be asked about any drugs you may be taking and any side effects you may be experiencing.
Study Visits for Participants in the Phase II Portion:
On Day 1 of all cycles, you will have the following tests and procedures performed.
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
On Days 1 and 28 of Cycle 1 and then every 3rd month, urine will be collected to check for markers of bone loss.
After Cycles 2, 4, 6 and so on, you will have CT scans, MRIs, and/or x-rays to check the status of the disease.
At all study visits, you will be asked about any drugs you may be taking and any side effects you may be experiencing.
Length of Study:
You may remain on study for as long as you are benefitting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
Once you go off-study, you will have an end-of-study visit.
* Your vital signs will be measured.
* Blood (about 1-2 teaspoons) and urine will be collected for routine tests.
* You will have MRIs, CT scans, and/or x-rays to check the status of the disease.
This is an investigational study. Zoledronic acid is FDA approved and commercially available for the treatment of breast cancer. Dasatinib is not FDA approved or commercially available for the treatment of breast cancer. It has been authorized for use in research only. Up to 28 patients will take part in this multicenter study. Up to 12 will be enrolled at MD Anderson.
Zoledronic acid is designed to strengthen the bone and prevent fractures or breaks in the bone. Dasatinib is designed to block (stop) cells responsible for the breakdown of bone.
Study Groups:
If you are found to be eligible to take part in this study, you will be enrolled in a group of at least 3 participants to begin receiving zoledronic acid and dasatinib. The dose of dasatinib you receive will depend on when you enrolled in this study. All participants will receive the same amount of zoledronic acid. The first group of participants will be treated with the lowest dose of dasatinib given in combination with zoledronic acid.
Once the highest tolerable dose level is found, up to 25 additional participants will be enrolled at that dose level. This is called the Phase II portion of the study.
Drug Administration:
You will receive zoledronic acid through a needle in your vein on Day 1 over 15 minutes. You will take dasatinib by mouth daily for 28 days. Dasatinib should be taken on an empty stomach or after a light meal. Every 28 days is called a study "cycle."
Study Visits for Participants in the Phase I Portion:
On Day 1 of Cycle 1, you will have the following tests and procedures performed.
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have an ECG.
On Day 8 of Cycle 1, you will have the following tests and procedures performed.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have an ECG.
On Day 15 of Cycle 1, you will have the following tests and procedures performed.
* You will have a physical exam.
* You will have a performance status evaluation.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have an ECG.
On Day 21 of Cycle 1, you will have the following tests and procedures performed.
* Your vital signs will be measured.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have an ECG.
On Day 1 of Cycle 2, you will have an ECG.
On Day 1 of all other cycles, you will have the following tests and procedures performed.
* You will have a physical exam.
* You will have a performance status evaluation.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
* You will have MRIs, CT scans, and/or x-rays to check the status of the disease.
On Days 1 and 28 of Cycle 1 and then every 3rd month, urine will be collected over 24 hours to check for markers of bone loss.
After Cycles 3, 6, 9 and so on, you will have CT scans, MRIs, and/or x-rays to check the status of the disease
At all study visits, you will be asked about any drugs you may be taking and any side effects you may be experiencing.
Study Visits for Participants in the Phase II Portion:
On Day 1 of all cycles, you will have the following tests and procedures performed.
* You will have a physical exam, including measurement of your vital signs.
* You will have a performance status evaluation.
* Blood (about 1-2 teaspoons) will be drawn for routine tests.
On Days 1 and 28 of Cycle 1 and then every 3rd month, urine will be collected to check for markers of bone loss.
After Cycles 2, 4, 6 and so on, you will have CT scans, MRIs, and/or x-rays to check the status of the disease.
At all study visits, you will be asked about any drugs you may be taking and any side effects you may be experiencing.
Length of Study:
You may remain on study for as long as you are benefitting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
Once you go off-study, you will have an end-of-study visit.
* Your vital signs will be measured.
* Blood (about 1-2 teaspoons) and urine will be collected for routine tests.
* You will have MRIs, CT scans, and/or x-rays to check the status of the disease.
This is an investigational study. Zoledronic acid is FDA approved and commercially available for the treatment of breast cancer. Dasatinib is not FDA approved or commercially available for the treatment of breast cancer. It has been authorized for use in research only. Up to 28 patients will take part in this multicenter study. Up to 12 will be enrolled at MD Anderson.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-01920 | REGISTRY | NCI CTRP | View |