Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
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
1 other identifier
interventional
122
7 countries
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2018
Typical duration for phase_3
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2018
CompletedFirst Posted
Study publicly available on registry
March 20, 2018
CompletedStudy Start
First participant enrolled
October 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2020
CompletedResults Posted
Study results publicly available
November 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedSeptember 28, 2023
September 1, 2023
1.9 years
March 7, 2018
September 10, 2021
September 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days
Randomization up to 33 days
Secondary Outcomes (3)
Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L
Randomization up to 33 days
Change in Platelet Count From Baseline (Nadir)
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.
Randomization up to 33 days
Study Arms (2)
Avatrombopag
EXPERIMENTALStudy 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.
Placebo
PLACEBO COMPARATORStudy 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sobi, Inc.lead
Study Sites (55)
Dova Site
Anaheim, California, 92801, United States
Dova Site
Bakersfield, California, 93309, United States
Dova Site
Riverside, California, 92501, United States
Dova Site
Santa Monica, California, 90403, United States
Dova Site
Augusta, Georgia, 30912, United States
Dova Site
Harvey, Illinois, 60426, United States
Dova Site
Skokie, Illinois, 60076, United States
Dova Site
Bloomington, Indiana, 47403, United States
Dova Site
Wichita, Kansas, 67214, United States
Dova Site
Ashland, Kentucky, 41101, United States
Dova Site
Boston, Massachusetts, 02114, United States
Dova Site
Minneapolis, Minnesota, 55417, United States
Dova Site
Canton, Ohio, 44718, United States
Dova Site
Gettysburg, Pennsylvania, 17325, United States
Dova Site
Harbin, China
Dova Site
Linyi, China
Dova Site
Neijiang, China
Dova Site
Shanghai, China
Dova Site
Tianjin, China
Dova Site
Budapest, Hungary
Dova Site
Debrecen, Hungary
Dova Site
Nyíregyháza, Hungary
Dova Site
Törökbálint, Hungary
Dova Site
Lublin, Poland
Dova Site
Olsztyn, Poland
Dova Site
Prabuty, Poland
Dova Site
Tomaszów Mazowiecki, Poland
Dova Site
Warsaw, Poland
Dova Site
Arkhangelsk, Russia
Dova Site
Kazan', Russia
Dova Site
Kursk, Russia
Dova Site
Moscow, Russia
Dova Site
Novosibirsk, Russia
Dova Site
Omsk, Russia
Dova Site
Pyatigorsk, 357502, Russia
Dova Site
Saint Petersburg, 188663, Russia
Dova Site
Saint Petersburg, Russia
Dova Site
Saransk, Russia
Dova Site
Sochi, Russia
Dova Site
Belgrade, Serbia
Dova Site
Kamenitz, Serbia
Dova Site
Kragujevac, Serbia
Dova Site
Cherkasy, Ukraine
Dova Site
Chernihiv, Ukraine
Dova Site
Chernivtsi, Ukraine
Dova Site
Ivano-Frankivsk, 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
Related Publications (1)
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.
PMID: 35240074BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP of Global Drug Development
- Organization
- Dova
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2018
First Posted
March 20, 2018
Study Start
October 12, 2018
Primary Completion
August 28, 2020
Study Completion
January 31, 2023
Last Updated
September 28, 2023
Results First Posted
November 24, 2021
Record last verified: 2023-09