Phase 3
Completed N=122
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
Chemotherapy-induced Thrombocytopenia
Source: ClinicalTrials.gov NCT03471078 ↗
Enrolled (actual)
122
Serious AEs
19.7%
Results posted
Nov 2021
Primary outcomePrimary: 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
◆ Published Evidence
Established
84citations · ~21 / year
Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 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.
Linked Publications
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Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 trial.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT03471078) and the linked publication. 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. Informational only — not medical advice.