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

September 19, 2023 updated by: Sobi, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

122

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Harbin, China
        • Dova Site
      • Linyi, China
        • Dova Site
      • Neijiang, China
        • Dova Site
      • Shanghai, China
        • Dova Site
      • Tianjin, China
        • Dova Site
  • Hungary
      • Budapest, Hungary
        • Dova Site
      • Debrecen, Hungary
        • Dova Site
      • Nyiregyhaza, Hungary
        • Dova Site
      • Törökbálint, Hungary
        • Dova Site
  • Poland
      • Lublin, Poland
        • Dova Site
      • Olsztyn, Poland
        • Dova Site
      • Prabuty, Poland
        • Dova Site
      • Tomaszów Mazowiecki, Poland
        • Dova Site
      • Warsaw, Poland
        • Dova Site
  • Russian Federation
      • Arkhangel'sk, Russian Federation
        • Dova Site
      • Kazan, Russian Federation
        • Dova Site
      • Kursk, Russian Federation
        • Dova Site
      • Moscow, Russian Federation
        • Dova Site
      • Novosibirsk, Russian Federation
        • Dova Site
      • Omsk, Russian Federation
        • Dova Site
      • Pyatigorsk, Russian Federation, 357502
        • Dova Site
      • Saint Petersburg, Russian Federation, 188663
        • Dova Site
      • Saint Petersburg, Russian Federation
        • Dova Site
      • Saransk, Russian Federation
        • Dova Site
      • Sochi, Russian Federation
        • Dova Site
  • Serbia
      • Belgrade, Serbia
        • Dova Site
      • Kragujevac, Serbia
        • Dova Site
      • Sremska Kamenica, Serbia
        • Dova Site
  • Ukraine
      • Cherkasy, Ukraine
        • Dova Site
      • Chernihiv, Ukraine
        • Dova Site
      • Chernivtsi, Ukraine
        • Dova Site
      • Ivano-Frankivs'k, Ukraine
        • Dova Site
      • Kharkiv, Ukraine
        • Dova Site
      • Kherson, Ukraine
        • Dova Site
      • Kropyvnytskyi, Ukraine
        • Dova Site
      • Kyiv, Ukraine
        • Dova Site
      • Odesa, Ukraine
        • Dova Site
      • Sumy, Ukraine
        • Dova Site
      • Ternopil', Ukraine
        • Dova Site
      • Uzhhorod, Ukraine
        • Dova Site
      • Vinnytsia, Ukraine
        • Dova Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Dova Site
      • Bakersfield, California, United States, 93309
        • Dova Site
      • Riverside, California, United States, 92501
        • Dova Site
      • Santa Monica, California, United States, 90403
        • Dova Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Dova Site
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Dova Site
      • Skokie, Illinois, United States, 60076
        • Dova Site
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Dova Site
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Dova Site
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Dova Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Dova Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Dova Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Dova Site
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Dova Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Randomization up to 33 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Randomization up to 33 days
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.
Randomization up to 33 days
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
Randomization up to 33 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sobi, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2018

Primary Completion (Actual)

August 28, 2020

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVA-CIT-330

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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