Skip to main content
OpenTrials
Completed

NCT Number: NCT03471078

Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chemotherapy-Induced Thrombocytopenia Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Thrombocytopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dova Site, Harbin, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avatrombopag

Drug

Oral avatrombopag tablet

Placebo oral tablet

Drug

Placebo comparator tablet

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sobi, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2023
First posted
Mar 20, 2018
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.