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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 : Completed
First Posted : March 20, 2018
Results First Posted : November 24, 2021
Last Update Posted : April 20, 2023
Sponsor:
Information provided by (Responsible Party):
Sobi, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Thrombocytopenia Drug: Avatrombopag Drug: Placebo Oral Tablet Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : October 12, 2018
Actual Primary Completion Date : August 28, 2020
Actual Study Completion Date : January 31, 2023
Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Avatrombopag
Oral avatrombopag tablet
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.
 Drug: Placebo Oral Tablet
Placebo comparator tablet


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days [ Time Frame: Randomization up to 33 days ]

Secondary Outcome Measures :
  1. Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L [ Time Frame: Randomization up to 33 days ]
    The duration of severe thrombocytopenia is defined as the total number of days with a platelet count <50×10^9/L during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day of Cycle X+2.

  2. Change in Platelet Count From Baseline (Nadir) [ Time Frame: Randomization up to 33 days ]

    Comparison of avatrombopag 60 mg vs. placebo, adjusted for the number of chemotherapy agents currently receiving per IWRS (1, ≥2).

    Cycle X nadir is defined as the lowest platelet count value prior to the first dose of study drug; Cycle X+1 nadir is defined as the lowest platelet count value during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day in Cycle X+2.


  3. Percentage of Subjects Who Did Not Have Major or Non-major Clinically Relevant Bleeding During the Period After Post-chemotherapy Study Drug Treatment in Cycle X+1 Through Chemotherapy Day of Cycle X+2. [ Time Frame: Randomization up to 33 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • 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
Contacts and Locations
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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): NCT03471078


Locations
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Sponsors and Collaborators
Sobi, Inc.
  Study Documents (Full-Text)

Documents provided by Sobi, Inc.:
Study Protocol  [PDF] April 4, 2019
Statistical Analysis Plan  [PDF] August 31, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sobi, Inc.
ClinicalTrials.gov Identifier: NCT03471078    
Other Study ID Numbers: AVA-CIT-330
First Posted: March 20, 2018    Key Record Dates
Results First Posted: November 24, 2021
Last Update Posted: April 20, 2023
Last Verified: April 2023

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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 Sobi, Inc.:
CIT
Thrombocytopenia
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases