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



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:3/2/2019
Start Date:October 12, 2018
End Date:November 2025
Contact:Dova Clinical
Email:clinical@dova.com
Phone:919-338-7878

Use our guide to learn which trials are right for you!

A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers

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, non-small cell lung and bladder cancer.

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.

Inclusion Criteria:

- Men and women greater than or equal to 18 years of age;

- A diagnosis of ovarian, non-small cell lung 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;

- Use of vitamin K antagonists;

- Participant has previously received a thrombopoietin receptor agonist for the
treatment of CIT
We found this trial at
16
sites
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Ashland, Kentucky 41101
?
mi
from
Ashland, KY
Click here to add this to my saved trials
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Bakersfield, California 93309
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Bloomington, Indiana 47403
?
mi
from
Bloomington, IN
Click here to add this to my saved trials
Budapest,
?
mi
from
Budapest,
Click here to add this to my saved trials
Canton, Ohio 44718
?
mi
from
Canton, OH
Click here to add this to my saved trials
Gettysburg, Pennsylvania 17325
?
mi
from
Gettysburg, PA
Click here to add this to my saved trials
Harvey, Illinois 60426
?
mi
from
Harvey, IL
Click here to add this to my saved trials
Minneapolis, Minnesota 55417
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Riverside, California 92501
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Santa Monica, California 90403
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Skokie, Illinois 60076
?
mi
from
Skokie, IL
Click here to add this to my saved trials
Wichita, Kansas 67214
?
mi
from
Wichita, KS
Click here to add this to my saved trials