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

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ClinicalTrials.gov Identifier: NCT03471078
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dova Pharmaceuticals

Brief 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, non-small cell lung and bladder cancer.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Thrombocytopenia Drug: Avatrombopag Drug: Placebo Oral Tablet Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2025

Arm Intervention/treatment
Experimental: Avatrombopag
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.
Drug: Avatrombopag
Oral avatrombopag tablet

Placebo Comparator: Placebo
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.
Drug: Placebo Oral Tablet
Placebo comparator tablet




Primary Outcome Measures :
  1. Evaluate the efficacy of avatrombopag in proportion of responders [ Time Frame: Randomization up to 33 days ]
    Proportion of subjects who do not require platelet transfusion, dose reduction in chemotherapy by 15%, or chemotherapy delay by >=4 days


Secondary Outcome Measures :
  1. Duration of severe thrombocytopenia defined as a platelet count <50 x 109/L [ Time Frame: Randomization up to 33 days ]
  2. Change in platelet count from baseline (nadir) [ Time Frame: Randomization up to 33 days ]
  3. Proportion of subjects without major or non-major clinically relevant bleeding [ Time Frame: Randomization up to 33 days ]
  4. Incidence of Adverse Events [ Time Frame: Up to 26 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471078


Contacts
Contact: Dova Clinical 919-338-7878 clinical@dova.com

Locations
United States, California
Dova Site Recruiting
Riverside, California, United States, 92501
United States, Kansas
Dova Site Recruiting
Wichita, Kansas, United States, 67214
United States, New York
Dova Site Recruiting
New York, New York, United States, 10016
United States, Ohio
Dova Site Recruiting
Canton, Ohio, United States, 44718
United States, Pennsylvania
Dova Site Recruiting
Gettysburg, Pennsylvania, United States, 17325
Sponsors and Collaborators
Dova Pharmaceuticals

Responsible Party: Dova Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03471078     History of Changes
Other Study ID Numbers: AVA-CIT-330
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dova Pharmaceuticals:
CIT
Thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases