CLINICAL TRIALS PROFILE FOR DASATINIB

505(b)(2) Clinical Trials for DASATINIB

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT02494882 ↗	Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older	Active, not recruiting	Incyte Corporation	Phase 1	2015-06-29	The purpose of this study is to test the safety of a new combination of three oral drugs in Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been studied before in humans. This is a phase I study in which ruxolitinib dose will start low for the first patient together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect, the ruxolitinib dose will slowly be made higher as new patients take part in the study. This will help the investigators find the right dose of ruxolitinib to give together with dexamethasone and dasatinib that will be used in future studies
New Combination	NCT02494882 ↗	Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older	Active, not recruiting	Incyte Pharmaceuticals	Phase 1	2015-06-29	The purpose of this study is to test the safety of a new combination of three oral drugs in Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been studied before in humans. This is a phase I study in which ruxolitinib dose will start low for the first patient together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect, the ruxolitinib dose will slowly be made higher as new patients take part in the study. This will help the investigators find the right dose of ruxolitinib to give together with dexamethasone and dasatinib that will be used in future studies
New Combination	NCT02494882 ↗	Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older	Active, not recruiting	Novartis Pharmaceuticals	Phase 1	2015-06-29	The purpose of this study is to test the safety of a new combination of three oral drugs in Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been studied before in humans. This is a phase I study in which ruxolitinib dose will start low for the first patient together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect, the ruxolitinib dose will slowly be made higher as new patients take part in the study. This will help the investigators find the right dose of ruxolitinib to give together with dexamethasone and dasatinib that will be used in future studies
New Combination	NCT02494882 ↗	Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older	Active, not recruiting	Memorial Sloan Kettering Cancer Center	Phase 1	2015-06-29	The purpose of this study is to test the safety of a new combination of three oral drugs in Ph+ ALL. These drugs are dexamethasone, dasatinib, and ruxolitinib. All three drugs have been studied before in humans. This is a phase I study in which ruxolitinib dose will start low for the first patient together with dexamethasone plus dasatinib. If this dose does not cause a bad side effect, the ruxolitinib dose will slowly be made higher as new patients take part in the study. This will help the investigators find the right dose of ruxolitinib to give together with dexamethasone and dasatinib that will be used in future studies

All Clinical Trials for DASATINIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00064233 ↗	BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate	Completed	Bristol-Myers Squibb	Phase 1	2003-11-01	RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.
NCT00064233 ↗	BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate	Completed	National Cancer Institute (NCI)	Phase 1	2003-11-01	RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.
NCT00064233 ↗	BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate	Completed	Jonsson Comprehensive Cancer Center	Phase 1	2003-11-01	RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	National Cancer Institute (NCI)	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
NCT00036738 ↗	Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, D	Completed	Fred Hutchinson Cancer Research Center	Phase 2	2001-07-13	This phase II trial is studying how well fludarabine phosphate and total-body irradiation followed by donor peripheral blood stem cell transplant work in treating patients with acute lymphoblastic leukemia or chronic myelogenous leukemia that has responded to previous treatment with imatinib mesylate, dasatinib, or nilotinib. Giving low doses of chemotherapy, such as fludarabine phosphate, and total-body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.

Clinical Trial Conditions for DASATINIB

Condition Name

Condition Name for DASATINIB
Intervention	Trials
Chronic Myeloid Leukemia	34
Leukemia	29
Acute Lymphoblastic Leukemia	21
Chronic Myelogenous Leukemia	13

Condition MeSH

Condition MeSH for DASATINIB
Intervention	Trials
Leukemia	180
Leukemia, Myeloid	120
Leukemia, Myelogenous, Chronic, BCR-ABL Positive	117
Leukemia, Lymphoid	73

Clinical Trial Locations for DASATINIB

Trials by Country

+

−

Trials by Country for DASATINIB
Location	Trials
Canada	100
United Kingdom	93
China	71
Australia	70
France	61

Trials by US State

+

−

Trials by US State for DASATINIB
Location	Trials
Texas	97
California	78
New York	59
Illinois	57
Florida	54

Clinical Trial Progress for DASATINIB

Clinical Trial Phase

Clinical Trial Phase for DASATINIB
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	19
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for DASATINIB
Clinical Trial Phase	Trials
Completed	147
Recruiting	55
Terminated	52

Clinical Trial Sponsors for DASATINIB

Sponsor Name

Sponsor Name for DASATINIB
Sponsor	Trials
Bristol-Myers Squibb	118
National Cancer Institute (NCI)	75
M.D. Anderson Cancer Center	35

Sponsor Type

Sponsor Type for DASATINIB
Sponsor	Trials
Other	398
Industry	213
NIH	78

Dasatinib: Clinical Trials, Market Analysis, and Projections

Introduction to Dasatinib

Dasatinib, marketed as SPRYCEL, is a second-generation tyrosine kinase inhibitor (TKI) used primarily in the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Here, we will delve into the clinical trials, market analysis, and future projections for dasatinib.

Clinical Trials and Efficacy

Head-to-Head Comparison with Imatinib

Clinical trials have compared dasatinib directly with imatinib, another TKI, in newly diagnosed adult patients with Ph+ CML in the chronic phase. The main goals of these trials were to evaluate the confirmed Complete Cytogenetic Response (cCCyR) and Major Molecular Response (MMR) at one year and over a five-year period.

• Confirmed Complete Cytogenetic Response (cCCyR): This response indicates no signs of abnormal cells in two bone marrow tests. Patients treated with dasatinib achieved a higher rate of cCCyR compared to those treated with imatinib, both at one year and at the end of the five-year study[1].
• Major Molecular Response (MMR): This is a sensitive test that detects low levels of BCR-ABL protein. More patients on dasatinib achieved MMR than those on imatinib at both one year and five years[1].

Time to Response

The median time to achieve cCCyR was significantly shorter for patients on dasatinib (3.1 months) compared to those on imatinib (5.8 months)[1].

Side Effects

While dasatinib has shown superior efficacy, it is not without side effects. Common side effects include diarrhea, cramping, and fatigue. It is crucial for patients to report any side effects to their doctors promptly to manage them effectively[1].

Market Analysis

Current Market Size and Growth

The dasatinib drugs market has experienced robust growth in recent years. As of 2023, the market size was valued at $1.36 billion and is expected to grow to $1.45 billion in 2024, with a compound annual growth rate (CAGR) of 6.6%[2][5].

Regional Breakdown

The market is segmented across various regions, with North America being the largest market in 2023. However, the Asia-Pacific region is expected to be the fastest-growing region in the forecast period[2][3].

Key Drivers

Several factors are driving the growth of the dasatinib market:

• Rising Incidence of CML: An increase in the number of patients diagnosed with CML has boosted demand for dasatinib[2][5].
• Advancements in Targeted Cancer Therapies: Continued research and advancements in TKIs have enhanced the efficacy and safety of dasatinib[2][5].
• Increased Investment in Oncology Research: Heightened investment in oncology has led to more clinical trials and better drug development[2][5].
• Growing Availability of Generic Dasatinib: The availability of generic versions of dasatinib is expected to increase accessibility and drive market growth[2][5].

Future Projections

Market Growth Forecast

The dasatinib drugs market is projected to continue its strong growth trajectory. By 2028, the market is expected to reach $1.87 billion, growing at a CAGR of 6.7%[2][5].

Key Trends

Several trends are expected to shape the future of the dasatinib market:

• Personalized Medicine: The adoption of personalized medicine approaches is likely to enhance treatment outcomes and drive market growth[2][5].
• Companion Diagnostics: The use of companion diagnostics will help in identifying the most suitable patients for dasatinib treatment, improving efficacy and reducing side effects[2][5].
• New Formulations and Combination Therapies: Developments in new formulations and combination therapies will further expand the treatment options available to patients[2][5].
• Biosimilars: The creation of biosimilars will provide more affordable alternatives, increasing market accessibility[2][5].

Regional Growth

The Asia-Pacific region is anticipated to be the fastest-growing market due to increasing healthcare investments, growing awareness of leukemia, and improved diagnostic capabilities[2][3].

Conclusion

Dasatinib has proven to be a highly effective treatment for Ph+ CML and Ph+ ALL, with superior clinical trial outcomes compared to imatinib. The market for dasatinib is expected to grow significantly, driven by increasing incidence of leukemia, advancements in targeted therapies, and heightened investment in oncology research. As the market evolves, trends such as personalized medicine, companion diagnostics, and the development of biosimilars will play crucial roles in shaping its future.

Key Takeaways

• Clinical Efficacy: Dasatinib has shown superior efficacy in achieving cCCyR and MMR compared to imatinib.
• Market Growth: The dasatinib market is projected to grow from $1.36 billion in 2023 to $1.87 billion by 2028.
• Regional Trends: The Asia-Pacific region is expected to be the fastest-growing market.
• Key Drivers: Rising incidence of CML, advancements in targeted therapies, and increased investment in oncology research are key drivers.
• Future Trends: Personalized medicine, companion diagnostics, new formulations, combination therapies, and biosimilars will shape the market's future.

FAQs

What is dasatinib used for?

Dasatinib is used to treat chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults and children[3].

How does dasatinib compare to imatinib in clinical trials?

Dasatinib has shown higher rates of confirmed Complete Cytogenetic Response (cCCyR) and Major Molecular Response (MMR) compared to imatinib in clinical trials[1].

What are the common side effects of dasatinib?

Common side effects include diarrhea, cramping, and fatigue. Patients should report any side effects to their doctors promptly[1].

What is the projected market size of dasatinib by 2028?

The dasatinib market is expected to reach $1.87 billion by 2028, growing at a CAGR of 6.7%[2][5].

Which region is expected to be the fastest-growing market for dasatinib?

The Asia-Pacific region is anticipated to be the fastest-growing market for dasatinib[2][3].

Sources

1. SPRYCEL® Ph+ CML Clinical Trial Results for Adults. SPRYCEL.
2. Dasatinib Drugs Market Report 2024. Research and Markets.
3. Dasatinib Drugs Market Size, Trends and Forecast to 2023. Coherent Market Insights.
4. Clinical Trials Using Dasatinib. National Cancer Institute.
5. Global Dasatinib Drugs Market Set For 6.7% Growth, Reaching $1.87 Billion By 2028. EIN Presswire.