MedTrace Logo

Avatrombopag for Thrombocytopenia in People With Cancer

NCT04437953 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-12-08

No results posted yet for this study

Summary

This study will test whether avatrombopag is an effective treatment for thrombocytopenia in people who have both cancer and a liver disease (such as cirrhosis, cholangitis, or hepatitis). Researchers will look at whether giving participants avatrombopag for 3 weeks can raise their platelet levels enough for them to begin chemotherapy. The study will also test whether avatrombopag can continue to be effective against thrombocytopenia while participants are on chemotherapy for 12 weeks or longer. In addition, researchers will determine how safe the study drug is in participants.

Conditions

Interventions

DRUG

Avatrombopag

Patients will receive an initial dose of Avatrombopag 60 mg on Day 1. Starting on Day 2, the dose will be Avatrombopag 20 mg daily. Once a patient has reached a platelet target of \> 100,000/mcL patients can initiate systemic cancer therapy. Avatrombopag will be continued as maintenance (subscript "m") and titrated weekly with a goal to maintain a platelet count of ≥ 100,000/mcL during administration of systemic cancer therapy. Duration of maintenance therapy will be at least 12 weeks (indicated by Week 1m, Week 2m, … 12m) starting from time of platelet correction and resumption of systemic cancer therapy. End of Treatment (EOT) is up to 15 weeks on study Week 12m.

Sponsors & Collaborators

Principal Investigators

  • Gerald Soff, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2020-12-03
Completion
2020-12-03
FDA Drug
Yes

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04437953 on ClinicalTrials.gov