Clinical trial NCT03471078: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-induced Thrombocytopenia
Keywords: CIT
Thrombocytopenia
Lead sponsor: Sobi, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-20
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days
timeFrame: Randomization up to 33 days
Secondary outcomes:
measure: Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L
timeFrame: Randomization up to 33 days
measure: Change in Platelet Count From Baseline (Nadir)
timeFrame: Randomization up to 33 days
measure: 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.
timeFrame: Randomization up to 33 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Dova Site
state: California
city: Bakersfield
country: United States
facility: Dova Site
state: California
city: Riverside
country: United States
facility: Dova Site
state: California
city: Santa Monica
country: United States
facility: Dova Site
state: California
city: Augusta
country: United States
facility: Dova Site
state: Georgia
city: Harvey
country: United States
facility: Dova Site
state: Illinois
city: Skokie
country: United States
facility: Dova Site
state: Illinois
city: Bloomington
country: United States
facility: Dova Site
state: Indiana
city: Wichita
country: United States
facility: Dova Site
state: Kansas
city: Ashland
country: United States
facility: Dova Site
state: Kentucky
city: Boston
country: United States
facility: Dova Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Dova Site
state: Minnesota
city: Canton
country: United States
facility: Dova Site
state: Ohio
city: Gettysburg
country: United States
facility: Dova Site
state: Pennsylvania
city: Harbin
country: China
facility: Dova Site
city: Linyi
country: China
facility: Dova Site
city: Neijiang
country: China
facility: Dova Site
city: Shanghai
country: China
facility: Dova Site
city: Tianjin
country: China
facility: Dova Site
city: Budapest
country: Hungary
facility: Dova Site
city: Debrecen
country: Hungary
facility: Dova Site
city: Nyiregyhaza
country: Hungary
facility: Dova Site
city: Törökbálint
country: Hungary
facility: Dova Site
city: Lublin
country: Poland
facility: Dova Site
city: Olsztyn
country: Poland
facility: Dova Site
city: Prabuty
country: Poland
facility: Dova Site
city: Tomaszów Mazowiecki
country: Poland
facility: Dova Site
city: Warsaw
country: Poland
facility: Dova Site
city: Arkhangel'sk
country: Russian Federation
facility: Dova Site
city: Kazan
country: Russian Federation
facility: Dova Site
city: Kursk
country: Russian Federation
facility: Dova Site
city: Moscow
country: Russian Federation
facility: Dova Site
city: Novosibirsk
country: Russian Federation
facility: Dova Site
city: Omsk
country: Russian Federation
facility: Dova Site
city: Pyatigorsk
country: Russian Federation
facility: Dova Site
city: Saint Petersburg
country: Russian Federation
facility: Dova Site
city: Saint Petersburg
country: Russian Federation
facility: Dova Site
city: Saransk
country: Russian Federation
facility: Dova Site
city: Sochi
country: Russian Federation
facility: Dova Site
city: Belgrade
country: Serbia
facility: Dova Site
city: Kragujevac
country: Serbia
facility: Dova Site
city: Sremska Kamenica
country: Serbia
facility: Dova Site
city: Cherkasy
country: Ukraine
facility: Dova Site
city: Chernihiv
country: Ukraine
facility: Dova Site
city: Chernivtsi
country: Ukraine
facility: Dova Site
city: Ivano-Frankivs'k
country: Ukraine
facility: Dova Site
city: Kharkiv
country: Ukraine
facility: Dova Site
city: Kherson
country: Ukraine
facility: Dova Site
city: Kropyvnytskyi
country: Ukraine
facility: Dova Site
city: Kyiv
country: Ukraine
facility: Dova Site
city: Odesa
country: Ukraine
facility: Dova Site
city: Sumy
country: Ukraine
facility: Dova Site
city: Ternopil'
country: Ukraine
facility: Dova Site
city: Uzhhorod
country: Ukraine
facility: Dova Site
city: Vinnytsia
country: Ukraine
facility: Dova Site
Study officials:
References:
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.