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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR BELEODAQ


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All Clinical Trials for Beleodaq

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00301756 ↗ Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors Completed National Cancer Institute (NCI) Phase 2 2006-09-01 This phase II trial studies how well belinostat works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that have spread to other places in the body or ovarian low malignant potential tumors. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT00334789 ↗ Belinostat and Isotretinoin in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery Completed National Cancer Institute (NCI) Phase 1 2006-06-12 This phase I trial is studying the side effects and best dose of belinostat when given together with isotretinoin in treating patients with metastatic or unresectable solid tumors. Belinostat may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Isotretinoin may cause solid tumor cells to look more like normal cells, and to grow and spread more slowly. Giving belinostat together with isotretinoin may be an effective treatment for metastatic or unresectable solid tumors.
NCT00351975 ↗ Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases Completed National Cancer Institute (NCI) Phase 1 2006-06-01 This phase I trial is studying the side effects and best dose of belinostat when given together with azacitidine in treating patients with advanced hematologic cancers or other diseases. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving belinostat together with azacitidine may kill more cancer cells.
NCT01273155 ↗ Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction Completed National Cancer Institute (NCI) Phase 1 2011-01-10 Background: - Belinostat is an experimental cancer treatment drug that works by helping to turn on genes that limit cell growth and survival of cancer cells. These genes are often switched off in tumors. Belinostat has been given to patients with different types of cancer to measure its safety and effectiveness, but it has not been given in a formal trial to cancer patients who have abnormal liver function. Because belinostat is processed by the liver, its safety and effectiveness needs to be established in individuals who have abnormal liver function. Researchers are interested in comparing the effects of belinostat as a cancer treatment drug in individuals with normal and abnormal liver function. Objectives: - To test the safety and effectiveness of belinostat in individuals who have solid tumors and lymphomas and who also have abnormal liver function. - To compare the results of belinostat treatment in individuals with normal and abnormal liver function. Eligibility: - Individuals at least 18 years of age who have been diagnosed with solid tumors or lymphomas that have not responded to standard treatment. - Individuals with normal liver function and varying degrees of abnormal liver function (mild, moderate, severe) are eligible. Design: - Participants will be screened with a full medical history and physical examination, as well as blood and urine tests, and tumor imaging studies. Participants will then be divided into study groups based on their liver function. - Participants will receive belinostat in cycles of treatment. Except for cycle 1, all cycles will last 21 days. Cycle 1 will last 28 days. For cycle 1 only, participants will receive a single dose of belinostat 1 week before the regular 21-day treatment cycle starts. - In each cycle, participants will receive belinostat once a day for 5 days, and will be asked to keep a medication diary to record any side effects. - Participants will have regular clinic visits with blood and urine sample collection and imaging studies to evaluate the cancer's response to treatment. - Participants may continue to take belinostat for as long as the cancer responds to the treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Beleodaq

Condition Name

Condition Name for Beleodaq
Intervention Trials
Previously Treated Myelodysplastic Syndrome 2
Secondary Acute Myeloid Leukemia 2
Recurrent Adult Acute Myeloid Leukemia 2
Hematological Malignancies 2
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Condition MeSH

Condition MeSH for Beleodaq
Intervention Trials
Neoplasms 5
Lymphoma 5
Lymphoma, Non-Hodgkin 3
Syndrome 3
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Clinical Trial Locations for Beleodaq

Trials by Country

Trials by Country for Beleodaq
Location Trials
United States 45
Canada 2
New Zealand 1
Spain 1
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Trials by US State

Trials by US State for Beleodaq
Location Trials
California 6
Florida 4
Texas 3
Ohio 3
Virginia 3
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Clinical Trial Progress for Beleodaq

Clinical Trial Phase

Clinical Trial Phase for Beleodaq
Clinical Trial Phase Trials
Phase 3 1
Phase 2 3
Phase 1 13
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Clinical Trial Status

Clinical Trial Status for Beleodaq
Clinical Trial Phase Trials
Completed 7
Recruiting 5
Not yet recruiting 2
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Clinical Trial Sponsors for Beleodaq

Sponsor Name

Sponsor Name for Beleodaq
Sponsor Trials
National Cancer Institute (NCI) 11
Acrotech Biopharma LLC 4
Spectrum Pharmaceuticals, Inc 4
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Sponsor Type

Sponsor Type for Beleodaq
Sponsor Trials
NIH 12
Industry 12
Other 6
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Beleodaq (Belinostat): Clinical Trials, Market Analysis, and Projections

Introduction to Beleodaq (Belinostat)

Beleodaq, also known as belinostat, is a histone deacetylase (HDAC) inhibitor developed by Acrotech Biopharma. It is specifically designed to treat adults with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and aggressive form of non-Hodgkin lymphoma (NHL)[1][3].

Clinical Trials and Efficacy

FDA Approval and Initial Trials

Belinostat was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in July 2014 for the treatment of PTCL. This approval was based on a clinical study involving 129 patients, where 25.8% of the subjects achieved a complete or partial response to the treatment. The most common side effects observed were anemia, fatigue, fever, nausea, and vomiting[1].

Ongoing and Planned Trials

Several clinical trials are ongoing or planned to further evaluate the efficacy and safety of belinostat in various settings:

  • Combination Therapies: A notable clinical trial is investigating the combination of belinostat with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or COP (without doxorubicin) in newly diagnosed PTCL patients. This study aims to determine the best dose of belinostat and pralatrexate when combined with these regimens and to compare the progression-free survival of patients treated with these combinations versus CHOP alone[4].

  • Phase II Studies: Previous phase II studies have shown promising results with belinostat in the relapsed/refractory PTCL setting, with minimal toxicities and an overall response rate of at least 25%[1].

  • Other Indications: Although primarily approved for PTCL, belinostat has been tested in phase I and II clinical trials for other hematologic malignancies and solid tumors, showing stability of disease with low rates of adverse events[1].

Market Analysis

Current Market Landscape

The HDAC inhibitor market, which includes belinostat, is anticipated to experience significant growth. Key drivers include the increasing incidence of cancer, heightened awareness, and an expanding pipeline of new HDAC inhibitors[3].

  • Market Size and Growth: The global HDAC inhibitor market is projected to grow at a substantial CAGR by 2034, driven by the development of novel HDAC inhibitors and their potential in treating various cancers and other conditions[3].

  • Competitive Landscape: Leading companies such as Xynomic Pharma, Medivir, Regency Pharmaceuticals, and Tenaya Therapeutics are developing new HDAC inhibitors. Belinostat, as one of the approved HDAC inhibitors, holds a significant position in this market[3].

Market Dynamics and Regulatory Factors

The approval process for HDAC inhibitors, including belinostat, is complex and closely scrutinized by regulatory bodies. Regulatory agencies are continually updating their guidelines and requirements, which can impact development timelines and market entry strategies[3].

  • Regulatory Approvals: The FDA's accelerated approval of belinostat for PTCL is contingent upon verification and description of clinical benefit in confirmatory trials. Similar regulatory scrutiny applies to other HDAC inhibitors in the pipeline[1][3].

Market Projections

Growth Potential

The HDAC inhibitor market, including belinostat, is expected to see substantial growth due to several factors:

  • Increasing Incidence of Cancer: The rising incidence of cancers, particularly blood-related cancers, is driving the demand for effective treatments like HDAC inhibitors[3].

  • Expanding Pipeline: The pipeline of new HDAC inhibitors, such as Abexinostat, Remetinostat, and Ricolinostat, is robust and expected to contribute to market growth[3].

  • Diverse Indications: HDAC inhibitors are being investigated for their potential in managing mental health conditions, fibrosis, inflammation, and diabetes, further expanding their market potential[3].

Challenges and Opportunities

While the market for HDAC inhibitors like belinostat is promising, there are challenges to be addressed:

  • Side Effects and Toxicity: The safety profile of HDAC inhibitors, including belinostat, must be carefully managed. Common side effects and the potential for toxicity can impact patient compliance and market growth[1].

  • Regulatory Hurdles: The complex and stringent regulatory approval process can delay market entry and impact the commercial success of these drugs[3].

  • Competition: The market is becoming increasingly competitive with multiple HDAC inhibitors in various stages of development. Differentiating belinostat and other approved HDAC inhibitors will be crucial for market success[3].

Key Takeaways

  • Clinical Efficacy: Belinostat has shown promising results in clinical trials for relapsed or refractory PTCL, with a significant overall response rate and manageable side effects.
  • Market Growth: The HDAC inhibitor market is projected to grow significantly, driven by the increasing incidence of cancer and the expanding pipeline of new HDAC inhibitors.
  • Regulatory Considerations: Regulatory approvals and ongoing clinical trials are critical for the continued success and expansion of belinostat and other HDAC inhibitors in the market.
  • Competitive Landscape: The market is competitive, with multiple companies developing new HDAC inhibitors, necessitating strong differentiation strategies for belinostat.

FAQs

What is Beleodaq (belinostat) used for?

Beleodaq (belinostat) is used to treat adults with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and aggressive form of non-Hodgkin lymphoma (NHL)[1].

How is Beleodaq administered?

Belinostat is administered intravenously at a dose of 1,000 mg/m² daily on days 1 to 5 of a 21-day cycle until disease progression or unacceptable toxicity[1].

What are the common side effects of Beleodaq?

Common side effects of belinostat include anemia, fatigue, fever, nausea, and vomiting[1].

Is Beleodaq approved for other indications?

Currently, belinostat is approved only for the treatment of relapsed or refractory PTCL. However, it is being investigated in clinical trials for other hematologic malignancies and solid tumors[1].

What is the market outlook for HDAC inhibitors like Beleodaq?

The HDAC inhibitor market is expected to grow significantly by 2034, driven by the increasing incidence of cancer and the development of new HDAC inhibitors[3].

Sources

  1. Aetna: Belinostat (Beleodaq) - Medical Clinical Policy Bulletins.
  2. Grand View Research: Global BELVIQ Market Size, Share, Growth | Industry Report 2025.
  3. GlobeNewswire: HDAC Inhibitor Market to Observe Stunning Growth During the Study Period 2020-2034.
  4. UCSF Clinical Trials: Belinostat or Pralatrexate in Combination Against CHOP Alone in Newly Diagnosed PTCL Patients.
  5. iHealthcareAnalyst: Epigenetics Drugs Market and Forecast 2024-2031.

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