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Trial record 11 of 19 for:    arog

A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations

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: NCT02283177
Recruitment Status : Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 29, 2014
First Posted Date  ICMJE November 5, 2014
Last Update Posted Date April 22, 2019
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
The safety and tolerability of crenolanib in combination with chemotherapy will be determined by assessing the adverse events experienced by patients. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2014)
  • Patients' serum and plasma samples will be collected and pharmacokinetic parameters including Cmax and AUC will be measured. [ Time Frame: day 4 and day 15 of induction 1; day 7 of consolidation 1 ]
  • Response rate [ Time Frame: day 14-28 of induction ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations
Official Title  ICMJE A Safety and Tolerability Trial of Crenolanib and Chemotherapy With Cytarabine and Anthracyclines in Patients With Newly Diagnosed Acute Myeloid Leukemia With FLT3 Activating Mutations
Brief Summary This pilot study is designed to evaluate the safety and tolerability of oral crenolanib besylate given sequentially during standard induction and consolidation chemotherapy in patients with newly diagnosed AML with FLT3 activating mutations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Newly Diagnosed AML With FLT3 Activating Mutations
Intervention  ICMJE
  • Drug: crenolanib
    Other Name: CP-868,596-26
  • Drug: cytarabine
  • Drug: daunorubicin
  • Drug: idarubicin
Study Arms  ICMJE
  • Experimental: Cohort A
    Patients will be given cytarabine and daunorubicin during induction therapy plus crenolanib at 100 mg TID.
    Interventions:
    • Drug: crenolanib
    • Drug: cytarabine
    • Drug: daunorubicin
  • Experimental: Cohort B
    Patients will be given cytarabine and idarubicin during induction therapy plus crenolanib at 100 mg TID.
    Interventions:
    • Drug: crenolanib
    • Drug: cytarabine
    • Drug: idarubicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2014)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Unequivocal diagnosis of AML based on the WHO classification, excluding acute promyelocytic leukemia
  2. No prior therapy for AML, except for hydroxyurea, in this setting is allowed.
  3. Subjects with AML evolving from MDS may have received prior MDS therapy with demethylating agents
  4. Subjects must have tested positive for FLT3-ITD and/or other FLT3 activating mutations
  5. Age ≥18 years
  6. ECOG PS 0 - 2
  7. Adequate liver function, defined as normal total bilirubin, ALT ≤2.0x ULN, and AST ≤2.0x ULN measured within 24 hours prior to crenolanib commencement
  8. Adequate renal function, defined as serum creatinine ≤1.5x ULN or GFR >50 mL/min
  9. Negative pregnancy test (serum or urine) for women of childbearing potential (WOCBP)

    • Women considered not of childbearing potential include any of the following: no menses for at least 2 years or menses within 2 years but amenorrheic for at least 2 months and luteinizing hormone (LH) and follicular stimulating hormone (FSH) values within normal range (according to definition of postmenopausal for laboratory used) or bilateral oophorectomy or radiation castration and amenorrheic for at least 3 months or with bilateral tubal ligation

  10. WOCBP must practice contraception. Acceptable methods of contraception are double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, tubal ligations, and abstention
  11. Male patients (except those with prior surgical contraceptive procedures) with female partners who are of childbearing potential: Recommendation is for male and partner to use effective contraceptive methods, such as latex condoms, during the study
  12. Able and willing to provide written informed consent

Exclusion Criteria:

  1. Pre-existing liver diseases (i.e., cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, and sclerosing cholangitis, etc.)
  2. Active CNS leukemia
  3. Subject with concurrent severe and/or uncontrolled medical conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy
  4. NYHA Class III-IV heart failure, myocardial infarction <6 months prior to study entry, and/or serious arrhythmia requiring anti-arrhythmic therapy
  5. Unable to swallow pills
  6. Major surgical procedures within 14 days of administration of crenolanib (does not include line placement as needed for chemotherapy administration).
  7. Unwillingness or inability to comply with protocol.
  8. Concurrent use of other investigational agents.
  9. Subjects who are not eligible for standard chemotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02283177
Other Study ID Numbers  ICMJE ARO-006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arog Pharmaceuticals, Inc.
Study Sponsor  ICMJE Arog Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arog Pharmaceuticals, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP