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

Primary Purpose

Chemotherapy-induced Thrombocytopenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Avatrombopag
Placebo Oral Tablet
Sponsored by
Sobi, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Thrombocytopenia focused on measuring CIT, Thrombocytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dova Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Avatrombopag

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days

Secondary Outcome Measures

Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L
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.
Change in Platelet Count From Baseline (Nadir)
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.
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.

Full Information

First Posted
March 7, 2018
Last Updated
September 19, 2023
Sponsor
Sobi, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03471078
Brief Title
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sobi, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Thrombocytopenia
Keywords
CIT, Thrombocytopenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avatrombopag
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Avatrombopag
Intervention Description
Oral avatrombopag tablet
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo comparator tablet
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L
Description
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.
Time Frame
Randomization up to 33 days
Title
Change in Platelet Count From Baseline (Nadir)
Description
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.
Time Frame
Randomization up to 33 days
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dova Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Dova Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Dova Site
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Dova Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Dova Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Dova Site
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Dova Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Dova Site
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Dova Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Dova Site
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
41101
Country
United States
Facility Name
Dova Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dova Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Dova Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Dova Site
City
Gettysburg
State/Province
Pennsylvania
ZIP/Postal Code
17325
Country
United States
Facility Name
Dova Site
City
Harbin
Country
China
Facility Name
Dova Site
City
Linyi
Country
China
Facility Name
Dova Site
City
Neijiang
Country
China
Facility Name
Dova Site
City
Shanghai
Country
China
Facility Name
Dova Site
City
Tianjin
Country
China
Facility Name
Dova Site
City
Budapest
Country
Hungary
Facility Name
Dova Site
City
Debrecen
Country
Hungary
Facility Name
Dova Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Dova Site
City
Törökbálint
Country
Hungary
Facility Name
Dova Site
City
Lublin
Country
Poland
Facility Name
Dova Site
City
Olsztyn
Country
Poland
Facility Name
Dova Site
City
Prabuty
Country
Poland
Facility Name
Dova Site
City
Tomaszów Mazowiecki
Country
Poland
Facility Name
Dova Site
City
Warsaw
Country
Poland
Facility Name
Dova Site
City
Arkhangel'sk
Country
Russian Federation
Facility Name
Dova Site
City
Kazan
Country
Russian Federation
Facility Name
Dova Site
City
Kursk
Country
Russian Federation
Facility Name
Dova Site
City
Moscow
Country
Russian Federation
Facility Name
Dova Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Dova Site
City
Omsk
Country
Russian Federation
Facility Name
Dova Site
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
Dova Site
City
Saint Petersburg
ZIP/Postal Code
188663
Country
Russian Federation
Facility Name
Dova Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Dova Site
City
Saransk
Country
Russian Federation
Facility Name
Dova Site
City
Sochi
Country
Russian Federation
Facility Name
Dova Site
City
Belgrade
Country
Serbia
Facility Name
Dova Site
City
Kragujevac
Country
Serbia
Facility Name
Dova Site
City
Sremska Kamenica
Country
Serbia
Facility Name
Dova Site
City
Cherkasy
Country
Ukraine
Facility Name
Dova Site
City
Chernihiv
Country
Ukraine
Facility Name
Dova Site
City
Chernivtsi
Country
Ukraine
Facility Name
Dova Site
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
Dova Site
City
Kharkiv
Country
Ukraine
Facility Name
Dova Site
City
Kherson
Country
Ukraine
Facility Name
Dova Site
City
Kropyvnytskyi
Country
Ukraine
Facility Name
Dova Site
City
Kyiv
Country
Ukraine
Facility Name
Dova Site
City
Odesa
Country
Ukraine
Facility Name
Dova Site
City
Sumy
Country
Ukraine
Facility Name
Dova Site
City
Ternopil'
Country
Ukraine
Facility Name
Dova Site
City
Uzhhorod
Country
Ukraine
Facility Name
Dova Site
City
Vinnytsia
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
35240074
Citation
Al-Samkari H, Kolb-Sielecki J, Safina SZ, Xue X, Jamieson BD. Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2022 Mar;9(3):e179-e189. doi: 10.1016/S2352-3026(22)00001-1.
Results Reference
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Learn more about this trial

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

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