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

Chemotherapy-induced Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471078
• Other study ID #: AVA-CIT-330
• Status: Completed
• Phase: Phase 3
• Start date: October 12, 2018
• Est. completion date: January 31, 2023

Study information

• Verified date: September 2023
• Source: Sobi, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 31, 2023
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Thrombocytopenia
• Thrombocytopenia

Intervention

Drug:
• Avatrombopag
Oral avatrombopag tablet
• Placebo Oral Tablet
Placebo comparator tablet

Locations

Country	Name	City	State
China	Dova Site	Harbin
China	Dova Site	Linyi
China	Dova Site	Neijiang
China	Dova Site	Shanghai
China	Dova Site	Tianjin
Hungary	Dova Site	Budapest
Hungary	Dova Site	Debrecen
Hungary	Dova Site	Nyiregyhaza
Hungary	Dova Site	Törökbálint
Poland	Dova Site	Lublin
Poland	Dova Site	Olsztyn
Poland	Dova Site	Prabuty
Poland	Dova Site	Tomaszów Mazowiecki
Poland	Dova Site	Warsaw
Russian Federation	Dova Site	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	Dova Site	Saint Petersburg
Russian Federation	Dova Site	Saint Petersburg
Russian Federation	Dova Site	Saransk
Russian Federation	Dova Site	Sochi
Serbia	Dova Site	Belgrade
Serbia	Dova Site	Kragujevac
Serbia	Dova Site	Sremska Kamenica
Ukraine	Dova Site	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
United States	Dova Site	Anaheim	California
United States	Dova Site	Ashland	Kentucky
United States	Dova Site	Augusta	Georgia
United States	Dova Site	Bakersfield	California
United States	Dova Site	Bloomington	Indiana
United States	Dova Site	Boston	Massachusetts
United States	Dova Site	Canton	Ohio
United States	Dova Site	Gettysburg	Pennsylvania
United States	Dova Site	Harvey	Illinois
United States	Dova Site	Minneapolis	Minnesota
United States	Dova Site	Riverside	California
United States	Dova Site	Santa Monica	California
United States	Dova Site	Skokie	Illinois
United States	Dova Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Sobi, Inc.

Countries where clinical trial is conducted

United States,  China,  Hungary,  Poland,  Russian Federation,  Serbia,  Ukraine, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Randomization up to 33 days
Secondary	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.	Randomization up to 33 days
Secondary	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