NCT05772546

Avatrombopag vs. Placebo for CIT in GI Malignancies

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Avatrombopag for Persistent Chemotherapy-Induced Thrombocytopenia in Patients With Gastrointestinal Malignancies (ACT-GI)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hanny Al-Samkari, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy. The names of the study drugs involved in this study are: * Avatrombopag (a thrombopoietin receptor agonist) * Matching placebo

Detailed description

This is a randomized, double-blinded, placebo-controlled, multicenter phase 2 clinical trial evaluating Avatrombopag versus placebo for Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies. Avatrombopag may increase or stimulate megakaryocytes, which aid in producing blood platelets, resulting in an increased production of platelets. * Participants will be "randomized" into one of the study groups: Group A: Avatrombopag or Group B: Matching placebo. Randomization means that a participant is put into a group by chance. * All patients who complete the study (whether they received avatrombopag or placebo) have the opportunity to receive avatrombopag to treat CIT through a special free drug program available only to the participants of this study. The U.S. Food and Drug Administration (FDA) has not approved avatrombopag for CIT, but it has been approved for other uses. Study procedures include screening for eligibility, treatment visits, and blood tests. Participants will receive the study treatment or placebo for up to seven weeks and will be followed for up to 42 days after the last dose. It is expected that about 60 people will take part in this research study. Swedish Orphan Biovitrum (Sobi), biopharmaceutical company, is supporting this research study by providing the study drugs and funding.

Conditions

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Chemotherapy-Induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Avatrombopag	Thrombopoietin receptor agonist, tablet taken orally.
DRUG	Matching Placebo	Lactose monohydrate, tablet taken orally.

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-01-02
• Completion: 2026-07-31
• First posted: 2023-03-16
• Last updated: 2026-03-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study