CLINICAL TRIALS PROFILE FOR DAUNOXOME

All Clinical Trials for DAUNOXOME

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00111345 ↗	Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents	Unknown status	Deutsche Krebshilfe e.V., Bonn (Germany)	Phase 2/Phase 3	2004-03-01	Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Against the background that about 40% of the patients still die from immediate causes of an underlying disease relapse or of nonresponse, it seems to be justifiable to intensify therapy - especially for high-risk patients - which on its parts will require an optimization of supportive measures. As the present risk stratification into standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the risk-adapted therapy strategy. The aim of the study is to improve prognosis in children with AML by intensification of cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.
NCT00005942 ↗	Liposomal Daunorubicin and SU5416 in Treating Patients With Hematologic Cancer That Has Not Responded to Initial Therapy	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2000-03-01	Phase I/II trial to study the effectiveness of liposomal daunorubicin and SU5416 in treating patients who have hematologic cancer that has not responded to initial therapy. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. SU5416 may stop the growth of hematologic cancer by stopping blood flow to the cancer
NCT00004207 ↗	Liposomal Daunorubicin in Treating Patients With Metastatic Breast Cancer	Unknown status	University of Leicester	Phase 1	1997-12-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of liposomal daunorubicin in treating patients who have metastatic breast cancer.
NCT00002985 ↗	Doxorubicin in Treating Patients With AIDS-Related Kaposi's Sarcoma	Completed	Roswell Park Cancer Institute	Phase 3	1996-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether doxorubicin is more effective than daunorubicin for AIDS-related Kaposi's sarcoma. PURPOSE: Randomized double-blinded phase III trial to determine if doxorubicin is more effective than daunorubicin in treating patients who have AIDS-related Kaposi's sarcoma.
NCT00002093 ↗	A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.	Completed	Nexstar Pharmaceuticals	Phase 3	1969-12-31	To compare the toxicity profiles (severity and time to onset from initiation of therapy) between daunorubicin (liposomal) and combination chemotherapy with doxorubicin/bleomycin/vincristine (ABV), with both regimens administered in combination with antiretroviral therapy. To compare the duration of responses, response rates, and times to response.

Clinical Trial Conditions for DAUNOXOME

Condition Name

Condition Name for DAUNOXOME
Intervention	Trials
Acute Myeloid Leukemia	3
Sarcoma	2
Previously Treated Myelodysplastic Syndromes	1
Acute Lymphocytic Leukemia	1

Condition MeSH

Condition MeSH for DAUNOXOME
Intervention	Trials
Leukemia	7
Leukemia, Myeloid, Acute	6
Leukemia, Myeloid	4
Sarcoma, Kaposi	3

Clinical Trial Locations for DAUNOXOME

Trials by Country

+

−

Trials by Country for DAUNOXOME
Location	Trials
United States	15
Germany	3
Italy	1
Denmark	1
Hong Kong	1

Trials by US State

+

−

Trials by US State for DAUNOXOME
Location	Trials
Texas	2
New York	2
Florida	2
Kansas	1
Tennessee	1

Clinical Trial Progress for DAUNOXOME

Clinical Trial Phase

Clinical Trial Phase for DAUNOXOME
Clinical Trial Phase	Trials
Phase 3	6
Phase 2/Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for DAUNOXOME
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	2
Unknown status	2

Clinical Trial Sponsors for DAUNOXOME

Sponsor Name

Sponsor Name for DAUNOXOME
Sponsor	Trials
University Hospital Muenster	2
National Cancer Institute (NCI)	2
Deutsche Krebshilfe e.V., Bonn (Germany)	2

Sponsor Type

Sponsor Type for DAUNOXOME
Sponsor	Trials
Other	16
Industry	5
NIH	2

DAUNOXOME: Clinical Trials, Market Analysis, and Projections

Introduction

DAUNOXOME, a liposomal formulation of daunorubicin, has been a significant player in the treatment of certain cancers, particularly in the context of HIV-related Kaposi's sarcoma. Here, we will delve into the current status of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Approval History

DAUNOXOME was approved by the FDA on April 8, 1996, for the first-line cytotoxic therapy of advanced HIV-related Kaposi's sarcoma[5].

Mechanism of Action

DAUNOXOME is designed to maximize the selectivity of daunorubicin for solid tumors. The liposomal formulation protects daunorubicin from degradation, minimizes protein binding, and reduces uptake by normal tissues. This results in higher accumulation of daunorubicin in tumors compared to conventional daunorubicin[2].

Current Clinical Trials

While DAUNOXOME itself is not currently in new clinical trials, its mechanism and formulation have inspired other studies. For instance, the CLOUD trial, which combined clofarabine with DAUNOXOME, was terminated and is no longer recruiting participants[4].

Market Analysis

Market Position

DAUNOXOME was one of the first liposomal formulations approved for cancer treatment, marking a significant milestone in nanotechnology-based cancer therapies. It has been used successfully in clinical practice, particularly for patients with HIV-related Kaposi's sarcoma[1].

Competition

The market for cancer treatments is highly competitive, with several other nanotechnology-based drugs approved or in clinical trials. For example, Abraxane (nanoparticle-bound albumin paclitaxel) and Doxil (liposomal doxorubicin) are competitors in the same therapeutic space[1].

Patient Population

The primary patient population for DAUNOXOME is those with advanced HIV-related Kaposi's sarcoma. However, the broader market includes patients with various solid tumors who could benefit from targeted, liposomal drug delivery systems.

Market Projections

Market Trends

The use of nanotechnology in cancer treatment is on the rise, driven by the need for more targeted and less toxic therapies. As research continues to advance, we can expect more sophisticated nanocarriers and therapeutic agents to enter the market.

Future Outlook

While DAUNOXOME itself may not see significant growth due to its established position and the emergence of newer therapies, the technology behind it continues to influence the development of new cancer treatments. The market for nanotechnology-based cancer drugs is projected to grow, driven by increasing demand for personalized and targeted therapies.

Challenges and Opportunities

Regulatory Environment

The regulatory environment for nanotechnology-based drugs is evolving, with stricter guidelines and more rigorous testing requirements. This can pose challenges but also ensures that only the most effective and safe treatments reach the market.

Technological Advancements

Advancements in nanotechnology offer opportunities for improving drug delivery systems. For instance, newer materials and formulations could enhance the efficacy and reduce the side effects of treatments like DAUNOXOME.

Side Effects and Safety Profile

DAUNOXOME has a distinct safety profile compared to conventional daunorubicin. Common side effects include nausea, fatigue, fever, diarrhea, and allergic reactions. The liposomal formulation generally reduces the cardiotoxicity associated with daunorubicin, making it a safer option for patients[2].

Key Takeaways

• Clinical Approval: DAUNOXOME was approved by the FDA in 1996 for the treatment of advanced HIV-related Kaposi's sarcoma.
• Mechanism of Action: The drug uses a liposomal formulation to target solid tumors more effectively.
• Market Position: It is one of the pioneering nanotechnology-based cancer drugs, but faces competition from newer therapies.
• Future Outlook: The market for nanotechnology-based cancer treatments is expected to grow, driven by the need for targeted therapies.
• Challenges and Opportunities: The regulatory environment and technological advancements will shape the future of such treatments.

FAQs

What is DAUNOXOME used for?

DAUNOXOME is used as a first-line cytotoxic therapy for advanced HIV-related Kaposi's sarcoma.

How does DAUNOXOME differ from conventional daunorubicin?

DAUNOXOME is a liposomal formulation that protects daunorubicin from degradation, reduces protein binding, and decreases uptake by normal tissues, leading to higher accumulation in tumors.

What are the common side effects of DAUNOXOME?

Common side effects include nausea, fatigue, fever, diarrhea, and allergic reactions.

Is DAUNOXOME still in clinical trials?

DAUNOXOME itself is not currently in new clinical trials, but its technology influences ongoing research in nanotechnology-based cancer treatments.

What is the market outlook for DAUNOXOME and similar drugs?

The market for nanotechnology-based cancer drugs is projected to grow, driven by the demand for targeted and less toxic therapies.

Sources

1. Cancer Nano-Therapies in the Clinic and Clinical Trials - National Cancer Institute
2. DaunoXome: Package Insert / Prescribing Information - Drugs.com
3. Rett Research & Clinical Pipeline - International Rett Syndrome Foundation
4. CLOUD: CLOfarabine Used with DaunoXome: Phase I - Orphanet
5. Search Orphan Drug Designations and Approvals - FDA