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About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

370533 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.
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Clinical Trials of Interest

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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 04/16/2021.
Displaying: 8 trials in your specialties ()
View trials across your selected specialties

Randomised Study of Oral Azacitidine vs Placebo Maintenance in AML or MDS Patients After Allo-SCT

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Acute Myeloid Leukemia, Myelodysplasia
View Full Trial
INTERVENTION

Drug: Oral azacitidine, Drug: Matched placebo

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Heartlands Hospital, Birmingham, United Kingdom

Brief Summary

This study will evaluate a new maintenance therapy with the aim of improving the outcome of patients with acute myeloid leukaemia (AML) and myelodysplasia (MDS) after stem cell transplantation.

Evaluating in Vivo AZA Incorporation in Mononuclear Cells Following Vidaza or CC486

  • Status
    Active, not recruiting
  • Phase
    Phase 2
  • Condition
    Myelodysplastic Syndromes, Acute Myeloid Leukemia, Chronic Myelom...
View Full Trial
INTERVENTION

Drug: Azacitidine, Drug: CC-486

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Nepean Hospital, Penrith, New South Wales, Australia

Brief Summary

Myelodysplastic Syndrome (MDS) is a group of blood disorders where the bone marrow does not produce enough mature red blood cells, white blood cells and platelets. In a healthy person, the bone marrow makes blood stem cells (immature cells, also called 'blasts') that become mature blood cells over time. In people with MDS, this process is affected and immature blood cells in the bone marrow do not mature fully to become healthy blood cells. This causes a lack of healthy blood cells that can function properly. With fewer healthy blood cells, infection, anaemia, or easy bleeding may occur. MDS can progress to acute myeloid leukaemia in 25-30% of patients, and if untreated it can be rapidly fatal. The purpose of this study is to evaluate the standard treatment, azacitidine (Vidaza) given as an injection under the skin compared to the same medication (called CC-486) taken as a tablet by mouth. Vidaza is approved by the Australian Therapeutics Goods Administration (TGA) as standard treatment for MDS. CC-486 is an experimental treatment. This means it is not an approved treatment for MDS in Australia. CC-486 is being developed to increase convenience and make it easier for patients to continue their treatment. So far it has been given to over 870 patients in studies across the world. The treatment in the injection and the tablet is the same. Studies like this one are being done to ensure the tablet works in the same way as the standard injected treatment. Vidaza is given by subcutaneous injection (ie under the skin) over an hour for 7 days every 4 weeks for as long as it continues to work. All study participants will receive active treatment (there is no placebo), and all participants will receive the standard injection for six treatment cycles followed by the new tablet medication taken once daily for 21 days every 4 weeks. This allows the researchers to compare the two ways of giving the medicine.

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes

  • Status
    Active, not recruiting
  • Phase
    Phase 2
  • Condition
    Myelodysplastic Syndromes
View Full Trial
INTERVENTION

Drug: Oral Azacitidine, Drug: Durvalumab

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Yale University, New Haven, Connecticut, United States

Brief Summary

Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason for removing the combination arm: Due to difficulties with dose-finding, the durvalumab plus CC-486 combination arm was closed to enrollment. Extension: An Extension Phase (EP) has been added to allow subjects who are currently receiving oral azacitidine BID and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine until the subject meets the criteria for study discontinuation.

The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS)

  • Status
    Active, not recruiting
  • Phase
    Phase 3
  • Condition
    Myelodysplastic Syndrome
View Full Trial
INTERVENTION

Drug: Placebo, Other: Best Supportiv Care (BSC), Drug: Oral Azacitidine

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Alta Bates Comprehensive Cancer Center, Berkeley, California, United States

Brief Summary

Evaluation of the Efficacy and Safety of Oral Azacitidine plus Best Supportive care versus Placebo and Best Supportive care in subjects with red blood cell (RBC) transfusion-dependent anemia and thrombocytopenia due to International Prognostic Scoring System (IPSS) lower risk myelodysplastic syndromes (MDS).

Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies

  • Status
    Completed
  • Phase
    Phase 1
  • Condition
    Leukemia, Metastatic Breast Cancer, Hematological Neoplasms, Non-...
View Full Trial
INTERVENTION

Drug: CC-486, Drug: Vidaza

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Scottsdale Healthcare Research Institute, Scottsdale, Arizona, United States

Brief Summary

This is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate in this study.

Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myelogenous Leukemia

  • Status
    Completed
  • Phase
    Phase 1
  • Condition
    Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia ...
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INTERVENTION

Drug: Subcutaneous (SC) Azacitidine, Drug: Oral Azacitidine, Drug: Oral Azacitidine

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

University of Florida, Gainesville, Florida, United States

Brief Summary

The purpose of this study is to determine whether a tablet form of azacitidine that taken by mouth is safe. This Phase I study will also look at different doses and different treatment schedules in order to better understand the effects (positive and negative) of oral azacitidine on the body and on the disease MDS, AML and CMML.

Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS).

  • Status
    Completed
  • Phase
    Phase 1 Phase 2
  • Condition
    Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
View Full Trial
INTERVENTION

Drug: CC-486

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

Memorial Sloan-Kettering Cancer Center., New York, New York, United States

Brief Summary

The purpose of the study is to determine the maximal tolerated dose and schedule of CC-486, known as oral azacitidine, in patients with AML or MDS after allogeneic hematopoetic stem cell transplant (HSCT). HSCT is more frequently used in AML or MDS as a potential curative therapy. However, disease recurrence/relapse and graft-versus-host disease (GVHD) remain the principal causes of fatal complications after transplantation. Oral azacitidine has significant activity in MDS and AML. Oral azacitidine has also demonstrated immunomodulatory activity in AML patients after allogeneic HSCT. An oral formulation of oral azacitidine provides a convenient route of administration and an opportunity to deliver the drug over a prolonged schedule.

Phase 1 Study of CC-486 in Japanese Subjects With Hematological Neoplasms

  • Status
    Other
  • Phase
    Phase 1
  • Condition
    Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia, Multiple...
View Full Trial
INTERVENTION

Drug: Oral azacitidine

Eligibility
  • Ages:
  • Sexes: All
  • Accepts Healthy Volunteers:
Locations

National Cancer Center Hospital East, Kashiwa, Chiba, Japan

Brief Summary

To identify the maximum tolerated dose (MTD) of oral azacitidine on different treatment schedules in Japanese subjects with hematological neoplasms