Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
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| ClinicalTrials.gov Identifier: NCT03471078 |
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Recruitment Status :
Active, not recruiting
First Posted : March 20, 2018
Last Update Posted : February 15, 2021
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Sponsor:
Dova Pharmaceuticals
Information provided by (Responsible Party):
Dova Pharmaceuticals
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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, lung (small cell and non-small cell) and bladder cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chemotherapy-induced Thrombocytopenia | Drug: Avatrombopag Drug: Placebo Oral Tablet | Phase 3 |
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) |
| Actual Enrollment : | 122 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Supportive Care |
| Official Title: | Randomized, Double-Blind, Placebo-Controlled Study With 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 |
| Actual Study Start Date : | October 12, 2018 |
| Actual Primary Completion Date : | August 28, 2020 |
| Estimated Study Completion Date : | August 2025 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Avatrombopag
Oral avatrombopag tablet |
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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.
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Drug: Placebo Oral Tablet
Placebo comparator tablet |
Primary Outcome Measures :
- 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 :
- Duration of severe thrombocytopenia defined as a platelet count <50 x 109/L [ Time Frame: Randomization up to 33 days ]
- Change in platelet count from baseline (nadir) [ Time Frame: Randomization up to 33 days ]
- Proportion of subjects without major or non-major clinically relevant bleeding [ Time Frame: Randomization up to 33 days ]
- 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, lung (small cell or non-small cell) or bladder cancer requiring systemic chemotherapy
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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
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
Locations
Show 55 study locations
Sponsors and Collaborators
Dova Pharmaceuticals
| Responsible Party: | Dova Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT03471078 |
| Other Study ID Numbers: |
AVA-CIT-330 |
| First Posted: | March 20, 2018 Key Record Dates |
| Last Update Posted: | February 15, 2021 |
| Last Verified: | October 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Dova Pharmaceuticals:
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CIT Thrombocytopenia |
Additional relevant MeSH terms:
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Thrombocytopenia Blood Platelet Disorders Hematologic Diseases |