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Trial record 1 of 2 for:    KD025 and IPF
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A 2-Part, Phase 2 Open-label and Crossover Study of Belumosudil for Treatment of Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02688647
Recruitment Status : Completed
First Posted : February 23, 2016
Results First Posted : September 8, 2022
Last Update Posted : September 8, 2022
Sponsor:
Information provided by (Responsible Party):
Kadmon Corporation, LLC

Brief Summary:

This Phase 2 study is to be conducted to evaluate the safety, tolerability, and activity of 400 mg of belumosudil orally (PO) once-daily (QD) compared to Best Supportive Care (BSC) in male and postmenopausal/surgically sterilized female subjects with Idiopathic Pulmonary Fibrosis (IPF). The primary objectives are to evaluate the:

  • Change in Forced Vital Capacity (FVC) from baseline to 24 weeks after dosing with belumosudil 400 mg PO QD in subjects with IPF compared to BSC
  • Safety and tolerability of belumosudil 400 mg PO QD when administered for 24 weeks to subjects with IPF compared to BSC

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Belumosudil Other: BSC Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

In Part 1: Subjects are randomized to treatment with either Belumosudil 400 mg PO QD (Belumosudil-R) or to BSC (BSC-R).

In Part 2: Subjects who are randomized and receive Belumosudil 400 mg PO QD during Part 1 have the option to continue treatment with Belumosudil 400 mg PO QD and subjects randomized to BSC have the option to cross over to treatment with Belumosudil 400 mg PO QD.

No subject is permitted > 96 weeks of treatment with belumosudil

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 2, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, and Activity of Belumosudil in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Actual Study Start Date : May 26, 2016
Actual Primary Completion Date : April 13, 2021
Actual Study Completion Date : April 13, 2021


Arm Intervention/treatment
Experimental: Belumosudil-R

Subjects receive two 200 mg tablets of belumosudil (400 mg) PO QD for 24 weeks. Subjects may also continue treatment with belumosudil 400 mg PO QD after 24 weeks.

No subject may receive more than 96 weeks of treatment with belumosudil

Drug: Belumosudil
Other Names:
  • KD025
  • SLx-2119

Active Comparator: BSC-R
Subjects receive best supportive care as determined by the physician. Subjects may later crossover to treatment with belumosudil 400 mg PO QD. No subject may receive more than 96 weeks of treatment with belumosudil.
Other: BSC
Treatment/drug as determined by each subject's prescribing physician
Other Name: Best standard of care




Primary Outcome Measures :
  1. Efficacy: Mean Changes in FVC From Baseline to Week 24 [ Time Frame: 24 weeks ]
    Changes in the mean Forced Vital Capacity (FVC) from baseline at Week 24. Normal FVC-- Healthy males 20 to 60 years: 4.75 to 5.5 L; healthy females 20 to 60 years: 3.25 to 3.75 L

  2. Efficacy: Mean Changes in FVC% Predicted From Baseline at Week 24 [ Time Frame: 24 weeks ]

    Changes in the mean Forced Vital Capacity (FVC)% Predicted from baseline at Week 24.

    Normal FVC%: 80% to 120%


  3. Safety: Percentages of Subjects With Non-serious TEAEs and Relationship to Study Treatment [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC had the option of crossing over at 24 weeks. ]

    Percentage of subjects with non-serious TEAEs by relationship to treatment with belumosudil, BSC, or belumosudil and BSC.

    Severity of TEAEs were measured using the Common Terminology Criteria for Adverse Events (CTCAE) version 22.1 (Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = fatal).


  4. Safety: Percentages of Subjects With SAEs Related to Study Treatment [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil. Subjects randomized to BSC and crossing over also up to 24 weeks of BSC. ]

    Percentage of subjects with serious TEAEs by relationship to treatment with belumosudil and/or BSC.

    Investigators assessed whether events were related to treatment as possibly, probably, or definitely related.


  5. Safety: Percentages of Subjects With TEAEs Leading to Discontinuation of Treatment With Belumosudil [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) of treatment with belumosudil ]

    Percentage of subjects with treatment-emergent adverse events (TEAEs) leading to subjects discontinuing from treatment.

    Investigators assessed whether TEAEs leading to discontinuation were related to study drug (possibly, probably, or definitely), belumosudil 400 mg PO QD.


  6. Safety: Percentages of Subjects With Deaths Related to Study Treatment [ Time Frame: Up to 96 weeks (Weeks 24, 8, and 96) of treatment with belumosudil. Subjects randomized to BSC also had the option of crossing over to treatment with belumosudil at 24 weeks. ]

    Percentage of subjects with deaths by relationship to treatment with belumosudil, BSC, or belumosudil and BSC.

    Investigators assessed whether events were related to treatment as possibly, probably, or definitely related.



Secondary Outcome Measures :
  1. Efficacy: Mean Changes in FVC From Baseline at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- [ Time Frame: 24 weeks ]

    Changes in the mean Forced Vital Capacities (FVC) at Week 24 by Gender/Age/Physiology (GAP) Stage and by the previous use of pirfenidone and/or nintedanib prior to the study for Belumosudil-WC compared to BSC-NC.

    Normal FVC--Healthy males 20 to 60 years: 4.75 to 5.5 L; healthy famles 20 to 60 years: 3.25 to 3.75 L

    GAP is measured by points as follows:

    (G) Gender: Female = 0 points; Male = 1 point (A) Age: ≤ 60 years = 0 points; 61-65 years = 1 point; > 65 years = 2 points (P) Physiology:

    • FVC% Predicted: > 75% = 0 points; 50-75% = 1 point; ≤ 50% = 2 points
    • DLCO% (diffusing lung capacity of carbon monoxide by % predicted) Predicted: > 55% = 0 points; 36-55% = 1 point, ≤ 35% = 2 points; cannot perform = 3 points

    GAP Stage:

    • Stage I Index = 0 to 3 points
    • Stage II Index= 4 to 5 points
    • Stage III Index = 6 to 8 points

  2. Efficacy: Mean Changes in FVC From Baseline at Week 48, Week 96, and EOT [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]
    Changes in the mean Forced Vital Capacity (FVC) from baseline at Weeks 48 and 96, and End-of-Treatment (EOT) Normal FVC: Healthy males 20 to 60 years: 4.75 to 5.25 L; healthy females 20 to 60 years: 3.25 to 3.75 L

  3. Efficacy: Mean Change in Mean FEV1/FVC Ratio From Baseline at Weeks 24, 48, and 96 and EOT [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]
    Change in the mean ratio of Forced Expiratory Volume in 1 Second (FEV1) divided by the Forced Vital Capacity (FVC) at Week 24, Week 48, Week 96, and End-of-Treatment (EOT) Normal FEV1: 80% to 120% FEV1/FVC = Within 5% of predicted ratio

  4. Efficacy: Mean Changes in FVC% Predicted at Week 24 by GAP Stage and by Use of Pirfenidone or Nintedanib-- [ Time Frame: 24 weeks ]

    Changes in the mean Forced Vital Capacities (FVC)% Predicted at Week 24 by Gender/Age/Physiology (GAP) Stage and by the previous use of pirfenidone and/or nintedanib prior to the study for Belumosudil-WC compared to BSC-NC.

    GAP is measured by points as follows:

    (G) Gender: Female = 0 points; Male = 1 point (A) Age: ≤ 60 years = 0 points; 61-65 years = 1 point; > 65 years = 2 points (P) Physiology:

    • FVC% Predicted: > 75% = 0 points; 50-75% = 1 point; ≤ 50% = 2 points
    • DLCO% (diffusing lung capacity of carbon monoxide by % predicted) Predicted: > 55% = 0 points; 36-55% = 1 point, ≤ 35% = 2 points; cannot perform = 3 points

    GAP Stage:

    • Stage I = 0 to 3 points
    • Stage II = 4 to 5 points
    • Stage III = 6 to 8 points

  5. Efficacy: Percentages of Subjects With Decrease ≥ 5% in FVC% Predicted From Baseline at Weeks 24, 48, and 96 [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]
    Percentage of subjects exhibiting at least a 5% decrease in Forced Vital Capacity (FVC)% Predicted from baseline at Week 24, at Week 48, and at Week 96

  6. Efficacy: Percentage of Subjects With Decrease ≥ 10% in FVC% Predicted at Weeks 24, 48, and 96 [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]
    Percentage of subjects who exhibited at least a 10% decrease in Forced Vital Capacity (FVC)% Predicted from baseline at Week 24, at Week 48, and at Week 96

  7. Efficacy: Mean Change in 6MWD at Weeks 24, 48, and 96 [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]

    The mean change in the 6-mile Walking Distance (6MWD), i.e., the distance a subject can walk in 6 minutes, from baseline to Week 24, to Week 48, and to Week 96.

    Positive change = improvement; negative change = worsening


  8. Efficacy: Percentages of Subjects With ≥ 50 Meter Improvement in 6MWD at Weeks 24, 48, and 96 [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]
    The percentage of subjects who have at least a 50 meter improvement in the 6-mile Walking Distance (6MWD), i.e., the distance a subject can walk in 6 minutes, from baseline to Week 24, Week 48, and Week 96.

  9. Efficacy: Mean Changes in DLCO (%) at Weeks 24, 48, and 96 [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]

    The diffusing capacity for carbon dioxide (DLCO) is a measure of the conductance of gas transfer from inspired gas to the red blood cells.

    Normal DLCO is > 75% of predicted up to 140%. Severity is generally rated as:

    • Mild: 60% to lower limit of normal
    • Moderate: 40% to 60%
    • Severe: < 40%

  10. Efficacy: Percentages of Subjects With Change From Baseline in DLCO (%) ≤ -15% at Weeks 24, 48, and 96 [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]

    Percentage of the number of subjects who exhibit less than a -15% decrease in diffusing capacity of carbon monoxide (DLCO), measured as % from baseline at Week 24, Week 48, and Week 96

    The diffusing capacity for carbon dioxide (DLCO) is a measure of the conductance of gas transfer from inspired gas to the red blood cells.

    Normal DLCO is > 75% of predicted up to 140%. Severity is generally rated as:

    • Mild: 60% to lower limit of normal
    • Moderate: 40% to 60%
    • Severe: < 40%

  11. Efficacy: Mean Changes in Total Lung Fibrosis Score, by HRCT, From Baseline at Weeks 24, 48, and 96 [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]

    The change in Total Lung Fibrosis mean score from baseline at Weeks 24, 48, and 96. Measurements using quantitative high-resolution computerized tomography (HRCT) and include (1) extent of fibrotic abnormality; (2) fibrosis score; (3) ground glass opacity; (4) honeycombing score; (5) kurtosis of lung voxel intensity; (6) skewness of lung voxel intensity; (7) standard deviation of voxel; (8) CT total lung volume; (9) normal lung; (10) reticular score; and (11) evaluation of change on sequential scans.

    The Quantitative Lung Fibrosis (QLF) score measures the extent of reticular patterns with architectural distortion due to fibrosis using a support vector machine classifier. Range: 0 to 100. Higher scores imply greater impairment.


  12. Efficacy: Categorical Changes in Lung Fibrosis as Observed by Sequential Scans of Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]
    The categorical changes of lung fibrosis using subjective visual assessments by radiologists from sequential scans at baseline, Week 24, Week 48, and Week 96. Changes were categorized as: (1) much better; (2) slightly better; (3) same; (4) slightly worse; and (5) much worse. This categorization is simplified as Better (Much or Slightly); Same; and Worse (Slightly or Much).

  13. Efficacy: Changes in Mean DTA Lung Fibrosis Score, by Radiologist Visual Assessment, From Baseline at Weeks 24, 48, and 96 [ Time Frame: Up to 96 Weeks (Weeks 24, 48, and 96) ]
    The change in Data-driven Texture Analysis (DTA) Lung Fibrosis mean score using sequential scans from Radiologist's Visual Reads from baseline to Weeks 24, 48, and 96. The change in DTA Lung Fibrosis mean score was measured using sequential scans from Radiologist's Visual Reads from baseline at Weeks 24, 48, and 96. DTA fibrosis score was computed as the number of Region of Interests (ROIs) classified as fibrotic divided by the total number of ROIs sampled from the lung segmentation volume. The DTA fibrosis score ranged from 0 - 100%, where higher scores indicated worsening of disease.

  14. Efficacy: Event-free Probability of Acute Exacerbation of IPF [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]

    Acute exacerbation of IPF was defined by the following symptoms within 1 month that could not be explained by other reasons: (1) aggravated dyspnea; (2) newly discovered chest interstitial lung abnormality (by radiograph or HRCT); (3) SpO2 decrease to < 88%.

    Acute exacerbation was diagnosed if Items #1 and #2 were present or if Items #1 and #3 were present and the following AEs did not occur: (A) any AE with the Preferred Term containing the word "infection" or "cardiac failure"; (B) pulmonary embolism; (C) pneumothorax.


  15. Efficacy: Event-free Probability of Progression of IPF [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]
    Progression of IPF exacerbation was defined as the probability of a subject exhibiting IPF time from baseline to any of the following: (1) probability of first respiratory-related hospitalization; (2) probability of respiratory-related death; absolute decline in FVC% Predicted value of ≥ 10% vs. FVC %; probability of predicted value recorded at baseline; and (4) probability of absolute decline in DLCO, adjusted for hemoglobin (Hb), Percent of predicted value of ≥ 15% vs. DLCO at baseline. Subjects randomized to and received BSC were censored on crossover.

  16. Efficacy: Event-free Probability of First Respiratory-related Hospitalization [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]

    Probability of first-related hospitalization defined as any AE where the high-level group term contained the terms "respiratory" and the AE resulted in a hospitalization. Subjects randomized and received BSC were censored on crossover.

    Note: The hazard ratios for Belumosudil-R vs. BSC-NC and for Belumosudil-WC vs. BSC-NC were not calculable.


  17. Efficacy: Event-free Probability of Respiratory-related Death [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]

    Probability of respiratory-related death, defined as any AE where the high-level group term contained the term "respiratory" and the AE resulted in a death.

    Subjects randomized to and who received BSC were censored on crossover.


  18. Efficacy: Mean Changes in SGRQ From Baseline at Weeks 24, 48 and 96 [ Time Frame: Up to 96 weeks (Weeks 24, 48, and 96) ]

    The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in subjects with obstructive airways disease consisting of 2 parts: (1) symptoms component (frequency & severity) with a 3-month recall; and (2) activities that cause or are limited by breathlessness. Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.

    Changes were assessed from baseline at Week 24, at Week 48, and at Week 96.

    The SGRQ scores range from 0 to 100, with higher scores indicating greater limitations. Based on empirical data and interviews with subjects, a mean change score of 4 units is associated with slightly efficacious treatment, 8 units for moderately efficacious change, and 12 units for very efficacious treatment




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A subject had to meet all of the following criteria to be eligible for the study:

  1. Adult male and postmenopausal/surgically sterilized female subjects at least 18 years of age (if female, was surgically sterilized [i.e., total hysterectomy, or bilateral salpingo-oophorectomy]).
  2. Able to provide written informed consent before the performance of any study specific procedures.
  3. IPF diagnosis within 5 years before study entry, proven according to the American Thoracic Society/European Respiratory Society consensus conference criteria, with surgical lung biopsy. In the absence of a surgical lung biopsy, high-resolution computerized tomography (HRCT) consistent with usual interstitial pneumonitis.
  4. Resting state pulse oximeter oxygen saturation (SpO2) ≥ 88% with or without supplemental oxygen, Forced Vital Capacity % (FVC%) ≥ 50% normal predicted value, and diffusing capcity (in the lung) of carbon monoxide (DLCO) ≥ 30% normal predicted value at baseline.
  5. Men with partners of childbearing potential willing to use 2 medically acceptable methods of contraception during the trial and for 3 months after the last dose of study drug. Effective birth control includes:

    1. Intrauterine device plus 1 barrier method
    2. Stable doses of hormonal contraception for ≥ 3 months (e.g., oral, injectible, implant, transdermal) plus 1 barrier method
    3. 2 barrier methods. Effective barrier methods were male or female condoms, diaphragms, and spermicides (creams or gels containing a chemical to kill sperm)
    4. Vasectomy.
  6. Have adequate bone marrow function:

    1. Absolute neutrophil count > 1500/mm^3
    2. Hemoglobin (Hb) > 9.0 g/L
    3. Platelets > 100,000/mm^3
  7. Willing to complete all study measurements and assessments in compliance with protocol
  8. Had either received pirfenidone and/or nintedanib or offered both treatments (with last dose administered at least 1 month before the expected start of study drug dosing). If either or both pirfenidone and nintedanib treatment had not been given, then documentation that the subject was offered both treatments must have been documented.

Exclusion Criteria:

A subject who met any of the following criteria was ineligible for the study:

  1. Interstitial lung disease caused by conditions other than IPF
  2. Severe concomitant illness limiting life expectancy (< 1 year)
  3. DLCO < 30% predicted
  4. Residual volume (RV) ≥ 120% predicted
  5. Obstructive lung disease: Forced Expiratory Volume in 1 Second (FEV1/FVC ratio < 0.70)
  6. Documented sustained improvement of the subject's IPF condition up to 12 months before study entry with or without IPF-specific therapy
  7. Pulmonary infection or upper respiratory tract infection (URTI) within 4 weeks before study entry
  8. Acute or chronic impairment (other than dyspnea) limiting the ability to comply with study requirements (e.g., pulmonary function tests [PFTs])
  9. Chronic heart failure with New York Heart Association Class III/IV or known left ventricular ejection fraction < 25%
  10. Moderate to severe hepatic impairment (i.e., Child-Pugh Class B or C)
  11. Estimated creatinine clearance < 30 mL/min
  12. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.0 * upper limit of normal (ULN)
  13. Hb < 75% of the lower limit of normal
  14. Systolic blood pressure < 100 mmHg
  15. Pregnant or breastfeeding female subject
  16. Men whose partner is pregnant or breastfeeding
  17. Current drug or alcohol dependence
  18. Chronic treatment with the following drugs within 4 weeks of study entry and during the study:

    1. Immunosuppressive or cytotoxic drugs including cyclophosphamide and azathioprine
    2. Antifibrotic drugs including pirfenidone, nintedanib, D-penicillamine, colchicine, tumor necrosis factor-alpha blockers, imatinib, and interferon-γ
    3. Chronic use of N-acetylcysteine prescribed for IPF (> 600 mg/day)
    4. Oral anticoagulants prescribed for IPF
  19. Treatment with endothelin receptor antagonists within 4 weeks before study entry
  20. Systemic treatment within 4 weeks before study entry with cyclosporine A or tacrolimus, everolimus, or sirolimus (calcineurin or mammalian target of rapamycin inhibitors)
  21. Previous exposure to belumosudil or known allergy/sensitivity to belumosudil or any other Rho-associated protein kinase 2 (ROCK2) inhibitor
  22. Planned treatment or treatment with another investigational drug within 4 weeks before study entry
  23. Taking a medication with the potential for QTc prolongation
  24. Taking a drug sensitive substrate of CYP enzymes
  25. Taking a strong inducer of CYP3A4
  26. Had consumed an herbal medication (e.g., St. John's Wort) or grapefruit/grapefruit juice within 14 days prior to the Week 1 Day 1 visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688647


Locations
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United States, Arizona
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
UC Davis Medical Center, Division of Pulmonary/CC/SM
Sacramento, California, United States, 95817
United States, Florida
St. Francis Medical Institute
Clearwater, Florida, United States, 33765
Pulmonary Disease Specialists, PA, d/b/a PDS Research
Kissimmee, Florida, United States, 34741
Central Florida Pulmonary Group, PA
Orlando, Florida, United States, 32803
United States, Georgia
Piedmont Healthcare Pulmonary and Critical Care Research
Austell, Georgia, United States, 30106
United States, North Carolina
Pulmonix, LLC
Greensboro, North Carolina, United States, 27403
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Kadmon Corporation, LLC
  Study Documents (Full-Text)

Documents provided by Kadmon Corporation, LLC:
Study Protocol  [PDF] March 3, 2020
Statistical Analysis Plan  [PDF] March 10, 2020

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Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT02688647    
Other Study ID Numbers: KD025-207
First Posted: February 23, 2016    Key Record Dates
Results First Posted: September 8, 2022
Last Update Posted: September 8, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kadmon Corporation, LLC:
Pulmonary Fibrosis
Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Belumosudil
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action