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

Sobi

Status and phase: Completed; Phase 3

Conditions: Chemotherapy-induced Thrombocytopenia

Treatments: Drug: Placebo Oral Tablet; Drug: Avatrombopag

Study type: Interventional

Funder types: Industry

Identifiers

NCT03471078

AVA-CIT-330

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups, including a placebo group

Avatrombopag

Experimental group

Description:

Study 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.

Treatment:

Drug: Avatrombopag

Placebo

Placebo Comparator group

Description:

Study 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.

Treatment:

Drug: Placebo Oral Tablet