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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avatrombopag | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avatrombopag | Drug | Oral avatrombopag tablet |
| |
| Placebo Oral Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days | Randomization up to 33 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L | The duration of severe thrombocytopenia is defined as the total number of days with a platelet count <50×10^9/L during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day of Cycle X+2. | Randomization up to 33 days |
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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
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dova Site | Anaheim | California | 92801 | United States | ||
| Dova Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35240074 | Background | Al-Samkari H, Kolb-Sielecki J, Safina SZ, Xue X, Jamieson BD. Avatrombopag for chemotherapy-induced thrombocytopenia in patients with non-haematological malignancies: an international, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Haematol. 2022 Mar;9(3):e179-e189. doi: 10.1016/S2352-3026(22)00001-1. |
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The study was conducted by qualified investigators at 71 sites in China, Hungary, Poland, Russia, Serbia, Ukraine, and the United States.
The first subject was enrolled 12October2018.
This was a Phase 3, randomized, double- blind, placebo controlled study of the efficacy and and safety of avatrombopag in subjects with chemotherapy induced thrombocytopenia and non active non-hematologic cancers.
The study was conducted by qualified investigators at 71 sites in China, Hungary, Poland, Russia, Serbia, Ukraine, and the United States.
The first subject was enrolled 12October2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Avatrombopag | Study is 2:1 randomization ratio (avatrombopag to placebo). 60 mg of Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment. Avatrombopag: Oral avatrombopag tablet |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 4, 2019 | Sep 9, 2021 |
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| Drug |
Placebo comparator tablet |
|
| Change in Platelet Count From Baseline (Nadir) |
Comparison of avatrombopag 60 mg vs. placebo, adjusted for the number of chemotherapy agents currently receiving per IWRS (1, ≥2). Cycle X nadir is defined as the lowest platelet count value prior to the first dose of study drug; Cycle X+1 nadir is defined as the lowest platelet count value during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day in Cycle X+2. |
| Randomization up to 33 days |
| Percentage of Subjects Who Did Not Have Major or Non-major Clinically Relevant Bleeding During the Period After Post-chemotherapy Study Drug Treatment in Cycle X+1 Through Chemotherapy Day of Cycle X+2. | Randomization up to 33 days |
| Bakersfield |
| California |
| 93309 |
| United States |
| Dova Site | Riverside | California | 92501 | United States |
| Dova Site | Santa Monica | California | 90403 | United States |
| Dova Site | Augusta | Georgia | 30912 | United States |
| Dova Site | Harvey | Illinois | 60426 | United States |
| Dova Site | Skokie | Illinois | 60076 | United States |
| Dova Site | Bloomington | Indiana | 47403 | United States |
| Dova Site | Wichita | Kansas | 67214 | United States |
| Dova Site | Ashland | Kentucky | 41101 | United States |
| Dova Site | Boston | Massachusetts | 02114 | United States |
| Dova Site | Minneapolis | Minnesota | 55417 | United States |
| Dova Site | Canton | Ohio | 44718 | United States |
| Dova Site | Gettysburg | Pennsylvania | 17325 | United States |
| Dova Site | Harbin | China |
| Dova Site | Linyi | China |
| Dova Site | Neijiang | China |
| Dova Site | Shanghai | China |
| Dova Site | Tianjin | China |
| Dova Site | Budapest | Hungary |
| Dova Site | Debrecen | Hungary |
| Dova Site | Nyíregyháza | Hungary |
| Dova Site | Törökbálint | Hungary |
| Dova Site | Lublin | Poland |
| Dova Site | Olsztyn | Poland |
| Dova Site | Prabuty | Poland |
| Dova Site | Tomaszów Mazowiecki | Poland |
| Dova Site | Warsaw | Poland |
| Dova Site | Arkhangelsk | Russia |
| Dova Site | Kazan' | Russia |
| Dova Site | Kursk | Russia |
| Dova Site | Moscow | Russia |
| Dova Site | Novosibirsk | Russia |
| Dova Site | Omsk | Russia |
| Dova Site | Pyatigorsk | 357502 | Russia |
| Dova Site | Saint Petersburg | 188663 | Russia |
| Dova Site | Saint Petersburg | Russia |
| Dova Site | Saransk | Russia |
| Dova Site | Sochi | Russia |
| Dova Site | Belgrade | Serbia |
| Dova Site | Kamenitz | Serbia |
| Dova Site | Kragujevac | Serbia |
| Dova Site | Cherkasy | Ukraine |
| Dova Site | Chernihiv | Ukraine |
| Dova Site | Chernivtsi | Ukraine |
| Dova Site | Ivano-Frankivsk | Ukraine |
| Dova Site | Kharkiv | Ukraine |
| Dova Site | Kherson | Ukraine |
| Dova Site | Kropyvnytskyi | Ukraine |
| Dova Site | Kyiv | Ukraine |
| Dova Site | Odesa | Ukraine |
| Dova Site | Sumy | Ukraine |
| Dova Site | Ternopil | Ukraine |
| Dova Site | Uzhhorod | Ukraine |
| Dova Site | Vinnytsia | Ukraine |
Study is 2:1 randomization ratio (avatrombopag to placebo). 60 mg Investigational product administered orally once daily for 5 days prior to chemotherapy and 5 days following chemotherapy treatment. Placebo Oral Tablet: Placebo comparator tablet |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Avatrombopag: Oral avatrombopag tablet |
| BG001 | 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. Placebo Oral Tablet: Placebo comparator tablet |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance Status | The Eastern Cooperative Oncology Group (ECOG) performance status score describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). 0=Fully active, able to carry on all pre-disease performance without restriction 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2=Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours | Count of Participants | Participants |
| |||||||||||||||
| Number of Eligible Chemotherapy Agents Currently Receiving per IWRS | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Platelet Count (x10⁹/L) | Mean | Standard Deviation | platelets x10⁹/L |
| |||||||||||||||
| Height (cm) | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight (kg) | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI (kg/m²) | Mean | Standard Deviation | kg/m² |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Who do Not Require Platelet Transfusion, Dose Reduction in Chemotherapy by 15%, or Chemotherapy Delay by >=4 Days | All randomized subjects | Posted | Count of Participants | Participants | Randomization up to 33 days |
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| Secondary | Duration of Severe Thrombocytopenia Defined as a Platelet Count <50 x 10^9/L | The duration of severe thrombocytopenia is defined as the total number of days with a platelet count <50×10^9/L during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day of Cycle X+2. | Posted | Mean | Standard Deviation | Days | Randomization up to 33 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Platelet Count From Baseline (Nadir) | Comparison of avatrombopag 60 mg vs. placebo, adjusted for the number of chemotherapy agents currently receiving per IWRS (1, ≥2). Cycle X nadir is defined as the lowest platelet count value prior to the first dose of study drug; Cycle X+1 nadir is defined as the lowest platelet count value during the period after post-chemotherapy study drug treatment in Cycle X+1 through Chemotherapy Day in Cycle X+2. | Posted | Mean | Standard Deviation | Platelets x 10^9/L | Randomization up to 33 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Did Not Have Major or Non-major Clinically Relevant Bleeding During the Period After Post-chemotherapy Study Drug Treatment in Cycle X+1 Through Chemotherapy Day of Cycle X+2. | Posted | Count of Participants | Participants | Randomization up to 33 days |
|
|
Adverse event data were collected during the Double-Blind Treatment Phase and included two 21- or 28-day chemotherapy cycles.
Adverse events were assessed by Investigators at each study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avatrombopag | Avatrombopag: Oral avatrombopag tablet | 2 | 82 | 16 | 82 | 71 | 82 |
| EG001 | Placebo | Placebo Oral Tablet: Placebo comparator tablet | 0 | 40 | 8 | 40 | 36 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increase | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
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| Cerebral ischaemia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Non-small cell lung cancer | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| Thombocytosis | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
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The disclosure restriction on the PI is that the sponsor will review results communications prior to public release and can embargo communications regarding trial results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Global Drug Development | Dova | 9193387864 | clinical@dova.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2020 | Oct 8, 2021 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C533238 | avatrombopag |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Subjects with ECOG Score 1 |
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| Subjects with ECOG Score 2 |
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| Subjects Receiving ≥ 2 Agents |
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