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Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers

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: NCT03471078
Recruitment Status : Active, not recruiting
First Posted : March 20, 2018
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Dova Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 7, 2018
First Posted Date  ICMJE March 20, 2018
Last Update Posted Date February 15, 2021
Actual Study Start Date  ICMJE October 12, 2018
Actual Primary Completion Date August 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
Evaluate the efficacy of avatrombopag in proportion of responders [ Time Frame: Randomization up to 33 days ]
Proportion of subjects who do not require platelet transfusion, dose reduction in chemotherapy by 15%, or chemotherapy delay by >=4 days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • Duration of severe thrombocytopenia defined as a platelet count <50 x 109/L [ Time Frame: Randomization up to 33 days ]
  • Change in platelet count from baseline (nadir) [ Time Frame: Randomization up to 33 days ]
  • Proportion of subjects without major or non-major clinically relevant bleeding [ Time Frame: Randomization up to 33 days ]
  • Incidence of Adverse Events [ Time Frame: Up to 26 weeks ]
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 Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
Official Title  ICMJE Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers
Brief Summary Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder cancer.
Detailed Description Subjects will receive placebo controlled test treatment for one cycle of chemotherapy followed by an observational cycle. Subjects will have the option to continue into an open label extension period for all remaining chemotherapy cycles within the current regimen. After the follow-up visit, all subjects will continue to a long-term safety follow-up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Chemotherapy-induced Thrombocytopenia
Intervention  ICMJE
  • Drug: Avatrombopag
    Oral avatrombopag tablet
  • Drug: Placebo Oral Tablet
    Placebo comparator tablet
Study Arms  ICMJE
  • Experimental: Avatrombopag
    Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.
    Intervention: Drug: Avatrombopag
  • Placebo Comparator: Placebo
    Study is 2:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment.
    Intervention: Drug: Placebo Oral Tablet
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
Actual Enrollment  ICMJE
 (submitted: July 20, 2020)
122
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2018)
120
Estimated Study Completion Date  ICMJE August 2025
Actual Primary Completion Date August 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women greater than or equal to 18 years of age;
  • A diagnosis of ovarian, lung (small cell or non-small cell) or bladder cancer requiring systemic chemotherapy
  • Participant receiving a chemotherapy regimen given in a 21 or 28-day cycle, including 1 or more of the following agents or class of agents:

    • Nucleoside analog, including gemcitabine and fluorouracil;
    • Carboplatin or cisplatin;
    • Anthracycline; or
    • Alkylating agent;
  • Participant experienced severe thrombocytopenia, defined as 2 platelet counts <50 x 109/L measured at least 24 hours apart, during the qualifying chemotherapy cycle, of their current chemotherapy regimen
  • ECOG performance status <=2

Exclusion Criteria:

  • Participant has experienced >=Grade 2 CIT other than during the current chemotherapy treatment regimen within 6 months of Screening;
  • Participant has any history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases;
  • Participant has received >2 previous lines of chemotherapy or is receiving whole brain radiation during the study treatment period;
  • Participant has a known medical history of genetic prothrombotic syndromes
  • Participant has a history of arterial or venous thrombosis within 3 months of screening;
  • Use of vitamin K antagonists;
  • Participant has previously received a thrombopoietin receptor agonist or recombinant human thrombopoietin for the treatment of CIT within 3 months of screening
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 China,   Hungary,   Poland,   Russian Federation,   Serbia,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03471078
Other Study ID Numbers  ICMJE AVA-CIT-330
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dova Pharmaceuticals
Study Sponsor  ICMJE Dova Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dova Pharmaceuticals
Verification Date October 2020

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