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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 08/05/2020.
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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 08/05/2020.
Displaying: 19 trials in your specialties ()
View trials across your selected specialties

A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment

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

Drug: Fedratinib

Eligibility
  • Ages: 18 to 75 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
Locations

University of Miami Miller School of Medicine, Miami, Florida, United States

Brief Summary

This is a Phase 1, multicenter, nonrandomized, open-label, single oral dose study to assess the PK of fedratinib in subjects with moderate and severe hepatic impairment, and in matched 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.

An Efficacy and Safety Study of Fedratinib Compared to Best Available Therapy in Subjects With DIPSS-intermediate or High-risk Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Primary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis
View Full Trial
INTERVENTION

Drug: FEDRATINIB, Drug: Best Available Therapy (BAT)

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

Saint Vincent's Hospital, Darlinghurst, New South Wales, Australia

Brief Summary

A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.

Decitabine With Ruxolitinib or Fedratinib for the Treatment of Accelerated/Blast Phase Myeloproliferative Neoplasms

  • Status
    Recruiting
  • Phase
    Phase 2
  • Condition
    Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neop...
View Full Trial
INTERVENTION

Drug: Decitabine, Drug: Ruxolitinib, Drug: Fedratinib

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

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Brief Summary

This phase II trial studies how well decitabine with ruxolitinib or fedratinib works before hematopoietic stem cell transplant in treating patients with accelerated/blast phase myeloproliferative neoplasms (tumors). Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ruxolitinib and fedratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a donor hematopoietic stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Decitabine, with ruxolitinib or fedratinib, may work better than multi-agent chemotherapy or no pre-transplant therapy, in treating patients with accelerated/blast phase myeloproliferative neoplasms.

Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis

  • Status
    Not yet recruiting
  • Phase
    Phase 2
  • Condition
    Primary Myelofibrosis, Secondary Myelofibrosis
View Full Trial
INTERVENTION

Drug: Cyclophosphamide, Drug: JAK Inhibitor, Drug: Fludarabine, Biological: Granulocyte Colony-Stimulating Factor, Drug: Melphalan, Drug: Mycophenolate Mofetil, Procedure: Peripheral Blood Stem Cell Transplantation, Drug: Tacrolimus, Radiation: Total-Body Irradiation

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

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Brief Summary

This phase II trial studies the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical (Haplo) transplantation for the treatment of primary or secondary myelofibrosis (MF). Haplo transplant has been shown to be safe and effective in patients with leukemia and lymphoma who don't have an available sibling donor. The primary risk of using Haplo HCT in patients with MF is graft failure as the graft failure rate has been historically higher with Haplo HCT than with other donor sources and higher with MF patients due to bone marrow fibrosis than in patients with other hematologic malignancies. JAK inhibitors when used in patients with MF may decrease the size of the spleen and decrease inflammation in the bone marrow. Therefore using a JAK inhibitor prior to Haplo transplant has the potential to decrease graft failure in patients with MF. Haplo transplants for patients with MF have been done successfully at multiple institutions in patients not on a study and are currently being covered by Medicare.

Influence of Fedratinib on the Pharmacokinetics of the Transporter Probe Substrates Digoxin, Rosuvastatin, and Metformin

  • Status
    Completed
  • Phase
    Phase 1
  • Condition
    Healthy Volunteers
View Full Trial
INTERVENTION

Drug: Fedratinib, Drug: Digoxin, Drug: Rosuvastatin, Drug: Metformin

Eligibility
  • Ages: 18 to 65 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
Locations

PPD Phase 1 Clinic, Austin, Texas, United States

Brief Summary

This is a nonrandomized, fixed-sequence, open-label study to evaluate the effect of a single dose of fedratinib on the PK, safety, and tolerability of single doses of digoxin, rosuvastatin, and metformin in healthy subjects. The subjects will participate as follows: - Screening phase - Treatment phase (includes baseline) - Follow-up telephone call Subjects will be screened for eligibility during the screening phase. Subjects who meet all inclusion criteria and none of the exclusion criteria will return to the clinical site on Day -1 for protocol-specified assessments, and will be domiciled at the clinical site from Day -1 through the morning of Day 22. During the study, blood samples will be collected at prespecified times for PK and PD. Urine samples will be collected at prespecified times for urinary PK evaluation of metformin. Subject safety will be monitored throughout the study.

An Efficacy and Safety Trial of Fedratinib in Subjects With DIPSS, Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis and Previously Treated With Ruxolitinib

  • Status
    Recruiting
  • Phase
    Phase 3
  • Condition
    Primary Myelofibrosis, Post-Polycythemia Vera, Myelofibrosis
View Full Trial
INTERVENTION

Drug: FEDRATINIB

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

University of Colorado Cancer Center, Aurora, Colorado, United States

Brief Summary

This is Single-Arm, Open-Label Efficacy and Safety Trial of Fedratinib in Subjects with DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High- Risk Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (post-PV MF), or Post-Essential Thrombocythemia Myelofibrosis (post-ET MF) and Previously Treated with Ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least a 35% reduction of spleen volume and one of the secondary objectives is to evaluate the safety of fedratinib

Effect of Rifampin and Efavirenz on the Pharmacokinetics of Fedratinib in Healthy Adult Subjects

  • Status
    Recruiting
  • Phase
    Phase 1
  • Condition
    Healthy Volunteers
View Full Trial
INTERVENTION

Drug: Fedratinib, Drug: Rifampin, Drug: Efavirenz

Eligibility
  • Ages: 18 to 65 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: Yes
Locations

Covance Clinical Research Unit Inc - Dallas, Dallas, Texas, United States

Brief Summary

This is a 2-part study to evaluate the effect of multiple doses of rifampin or efavirenz on the PK, safety, and tolerability of single doses of fedratinib in healthy subjects. Each study part will consist of a nonrandomized, fixed-sequence, open-label design. The study parts can be run in any order or in parallel. Subjects may participate in one part only. For each part, subjects will participate as follows: - Screening - Treatment period (includes baseline) - Follow-up telephone call (4 days [± 2 days] after discharge) During the study, blood samples will be collected at prespecified times for PK. Subject safety will be monitored throughout the study.

Open Label Pharmacokinetic Study of SAR302503 in Subjects With Renal Impairment

  • Status
    Completed
  • Phase
    Phase 1
  • Condition
    Renal Impairment
View Full Trial
INTERVENTION

Drug: SAR302503

Eligibility
  • Ages: 18 to 79 Years (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Investigational Site Number 840002, Orlando, Florida, United States

Brief Summary

Primary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.

Phase 2 Study in Japanese Patients With Intermediate-2 or High Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly

  • Status
    Completed
  • Phase
    Phase 2
  • Condition
    Myelofibrosis
View Full Trial
INTERVENTION

Drug: SAR302503

Eligibility
  • Ages: 20 Years and older (Adult, Older Adult)
  • Sexes: All
  • Accepts Healthy Volunteers: No
Locations

Investigational Site Number 392010, Akita-Shi, Japan

Brief Summary

Primary Objective: - To evaluate the efficacy of daily oral doses of 300 mg, 400 mg, and 500 mg SAR302503 and combined for the response rate defined with the ≥35% reduction of spleen volume as determined by magnetic resonance imaging (MRI or computed tomography scan [CT] in patients with contraindications for MRI). Secondary Objectives: - To evaluate the safety of SAR302503 for both pooled (300, 400, and 500mg) and individual doses population. - To evaluate the pharmacokinetics (PK) of SAR302503 after single and repeat-dose. - To evaluate the effect on Myelofibrosis (MF)-associated symptoms (Key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF). - To evaluate the durability of splenic response. - To evaluate the effect of SAR302503 on bone marrow with regard to changes on reticulin fibrosis.

Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia

  • Status
    Completed
  • Phase
    Phase 2
  • Condition
    Hematopoietic Neoplasm
View Full Trial
INTERVENTION

Drug: SAR302503

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

Investigational Site Number 840008, Scottsdale, Arizona, United States

Brief Summary

Primary Objective: - Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for : - Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months in patients with polycythemia vera, and - Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients with essential thrombocythemia. - PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for: - Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with PV, and - Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with ET. Secondary Objectives: - To evaluate the safety of SAR302503. - To evaluate the efficacy of SAR302503 in patients with PV who are resistant or intolerant to hydroxyurea for inducing absence of phlebotomy eligibility. - To evaluate the efficacy of SAR302503 in patients with ET who are resistant or intolerant to hydroxyurea for reduction of platelet counts. - To evaluate the efficacy of SAR302503 in inducing complete and partial responses beginning at Day 1 of Cycle 6 visit through Cycle 8. - To evaluate splenic response as measured by spleen volume using MRI or CT. - To evaluate the pharmacokinetics of SAR302503 after single and repeat doses. - To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition. - To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated symptoms, as well as overall impact on quality of life. - To measure generic health-related quality of life and utility value using the EuroQol Group (EQ-5DTM) questionnaire.