Phase 3 N=122 Randomized Double-blind Supportive Care

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

Chemotherapy-induced Thrombocytopenia

Bottom Line

View on ClinicalTrials.gov: NCT03471078 ↗

Enrolled (actual)

122

Serious AEs

19.7%

Results posted

Nov 2021

Primary outcome: Primary: Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days — 57; 29 Participants — p=0.7186

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Avatrombopag (Drug); Placebo Oral Tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sobi, Inc.
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days	57; 29	0.7186
SECONDARY Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L	4.6; 4.7	0.8372
SECONDARY Change in Platelet Count From Baseline (Nadir)	51.5; 29.1	—
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.	82; 40	—

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.

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 =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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03471078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.