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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:

342,868 studies
in
216 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/04/2020.
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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 08/04/2020.
Displaying: 27 trials in your specialties ()
View trials across your selected specialties

A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.

  • Status
    Recruiting
  • Phase
    Phase 1
  • Condition
    Hepatic Impairment
View Full Trial
INTERVENTION

Drug: Enasidenib

Eligibility
  • Ages: 40 to 65 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

DaVita Clinical Research, Lakewood, Colorado, United States

Brief Summary

This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of enasidenib (CC-90007) in subjects with moderate and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

  • Status
    Recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Children, Adolescents and Young Adults With Refractory or Recurre...
View Full Trial
INTERVENTION

Drug: Ribociclib, Drug: Topotecan, Drug: Temozolomide, Drug: AZD1775, Drug: Carboplatin, Drug: Olaparib, Drug: Irinotecan, Drug: Nivolumab, Drug: Enasidenib, Drug: Lirilumab

Eligibility
  • Ages: up to 18 / (18 to 64 years)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Rigshospitalet, Copenhagen, Denmark

Brief Summary

The first molecular profiling protocols have been launched in Europe (MOSCATO-01 (Geoerger 2014), MAPPYACTS, INFORM, iTHER, SM-PAEDS, etc.) determining multiple actionable alterations in pediatric recurrent cancers. Increasingly, stratified approaches are being implemented to enrich clinical trials of molecularly targeted agents and possibly improve outcomes in specific populations i.e. a molecularly enriched/predictive biomarker-driven approach. The diversity and heterogeneity of the detected molecular alterations and the low number of pediatric patients mandate an adapted, innovative trial design for the attributed treatment options in order to satisfy the current unmet medical need. This basket trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe.

A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blas...
View Full Trial
INTERVENTION

Drug: AG-120, Drug: Placebo for AG-120, Drug: AG-221, Drug: Placebo for AG-221

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Erasmus MC, Rotterdam, Netherlands

Brief Summary

AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period.

Phase 1/2 Study of AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation

  • Status
    Active, not recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Hematologic Neoplasms
View Full Trial
INTERVENTION

Drug: AG-221

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

City of Hope, Duarte, California, United States

Brief Summary

Study AG221-C-001 is a Phase 1/2, multicenter, open-label, dose-escalation, safety, PK/PD, and clinical activity evaluation of orally administered AG-221 in subjects with advanced hematologic malignancies that harbor an IDH2 mutation. The study includes a dose escalation phase to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) and an expansion phase to further evaluate the safety, tolerability and clinical activity of AG-221 in select populations.

A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia

  • Status
    Recruiting
  • Phase
    Phase 1
  • Condition
    Acute Myeloid Leukemia
View Full Trial
INTERVENTION

Drug: CPX-351, Drug: Venetoclax, Drug: Midostaurin, Drug: Enasidenib

Eligibility
  • Ages: 18 to 75 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

City of Hope National Medical Center, Duarte, California, United States

Brief Summary

JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia (AML) who are fit to receive intensive chemotherapy (ICT). Subjects will be assigned to treatment arms based on results of AML mutation testing.

Combined Ruxolitinib and Enasidenib in Patients With Accelerated/Blast-phase Myeloproliferative Neoplasm or Chronic-phase Myelofibrosis With an IDH2 Mutation

  • Status
    Not yet recruiting
  • Phase
    Phase 2
  • Condition
    Accelerated/Blast-phase Myeloproliferative Neoplasm, Chronic-phas...
View Full Trial
INTERVENTION

Drug: Ruxolitinib, Drug: Enasidenib

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
Locations

Taussig Cancer Center Institute, Cleveland, Ohio, United States

Brief Summary

The presence of IDH mutation is associated with worse survival in patients with myelofibrosis. Moreover IDH mutations are among the most frequently encountered events in MPNs that have progressed to acute myeloid leukemia. Ruxolitinib, a JAK1/2 inhibitor, and enasidenib an IDH2 inhibitor are effective and tolerable treatments for patients with myelofibrosis (MF) and acute myeloid leukemia (AML), respectively. The study team hypothesize that the combination of these agents in patients with MPN with an IDH2 mutation will improve the overall clinical response to therapy.

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

  • Status
    Recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Previously Untreated Acute Myeloid Leukemia
View Full Trial
INTERVENTION

Biological: Samalizumab (BAML-16-001-S1), Biological: BI 836858 (BAML-16-001-S2), Other: Laboratory Biomarker Analysis, Drug: Daunorubicin (BAML-16-001-S1), Drug: Cytarabine (BAML-16-001-S1), Drug: Azacitidine (BAML-16-001-S2), Drug: AG-221 (BAML-16-001-S3), Drug: Azacitidine (BAML-16-001-S3), Drug: Entospletinib (BAML-16-001-S4), Drug: Azacitidine (BAML-16-001-S4), Drug: Entospletinib (BAML-16-001-S5), Drug: Decitabine (BAML-16-001-S5), Drug: Entospletinib (BAML-16-001-S6), Drug: Daunorubicin (BAML-16-001-S6), Drug: Cytarabine (BAML-16-001-S6), Drug: Pevonedistat (BAML-16-001-S9), Drug: Azacitidine (BAML-16-001-S9), Drug: AG-120 (BAML-16-001-S16), Drug: Azacitidine (BAML-16-001-S16), Drug: Gilteritinib (BAML-16-001-S8), Drug: Decitabine (BAML-16-001-S8)

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Mayo Clinic Arizona, Phoenix, Arizona, United States

Brief Summary

This screening and multi-sub-study Phase 1b/2 trial will establish a method for genomic screening followed by assigning and accruing simultaneously to a multi-study "Master Protocol (BAML-16-001-M1)." The specific subtype of acute myeloid leukemia will determine which sub-study, within this protocol, a participant will be assigned to evaluate investigational therapies or combinations with the ultimate goal of advancing new targeted therapies for approval. The study also includes a marker negative sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
View Full Trial
INTERVENTION

Drug: Enasidenib, Drug: Enasidenib Mesylate

Eligibility
  • Ages: 24 to 18 Months (Child)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Arkansas Children's Hospital, Little Rock, Arkansas, United States

Brief Summary

This trial studies the side effects of enasidenib and to see how well it works in treating patients with acute myeloid leukemia that has come back after treatment (relapsed) or has been difficult to treat with chemotherapy (refractory). Patients must also have a specific genetic change, also called a mutation, in a protein called IDH2. Enasidenib may stop the growth of cancer cells by blocking the mutated IDH2 protein, which is needed for cell growth.

Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers

  • Status
    Not yet recruiting
  • Phase
    Phase 1 Phase 2
  • Condition
    Refractory Cancer, IDH2 Gene Mutation, Acute Myeloid Leukemia, Re...
View Full Trial
INTERVENTION

Drug: Enasidenib, Drug: Venetoclax

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Brief Summary

The purpose of this research study is to see how safe and tolerable, and to find the highest or best dose, of an investigational combination of drugs called enasidenib and venetoclax, in patients with relapsed (the cancer has come back) or refractory (the cancer does not respond or have stopped responding to treatment) acute myeloid leukemia (AML, a type of blood cancer). This study will also see how useful the combination of enasidenib and venetoclax is in the treatment of patients with relapsed or refractory AML.

CPX-351 and Enasidenib in Treating Patients With Relapsed Acute Myeloid Leukemia Characterized by IDH2 Mutation

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Blasts 5 Percent or More of Bone Marrow Nucleated Cells, IDH2 Gen...
View Full Trial
INTERVENTION

Drug: Enasidenib Mesylate, Drug: Liposome-encapsulated Daunorubicin-Cytarabine

Eligibility
  • Ages: 18 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

Brief Summary

This phase II trial studies how well CPX-351 and enasidenib work in treating patients with acute myeloid leukemia characterized by IHD2 mutation that has come back. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CPX-351 and enasidenib may work better in treating patients with acute myeloid leukemia.