Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000606-29 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).
This is an open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navitoclax, ABT-263 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navitoclax | Drug | QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse Events - The number of participants with adverse events will be reported as a measure of Safety. | The investigators will monitor each subject for clinical and lab evidence of adverse events on a routine basis through out the study. The investigators will question each subject regarding any adverse effects that they have experienced and record any events on the care report forms. All adverse events will be followed to a satisfactory clinical resolution. | Adverse events occuring through the Final Visit (up to Week 52) will be reported |
| Safety: Physical Examination and Vital Signs - Physical examination will be performed and vital signs will be assessed for participants as a measure of safety. | Physical exam, blood pressure, pulse, body temperature will be measured and recorded | Change from baseline through Final Visit (up to Week 52). |
| Safety: Clinical Lab Tests will be performed for each participant as a safety measure. | Chemistry, hematology, urinalysis lab tests will be measured and recorded. All clinically significant values will be followed by the investigator to a satisfactory clinical resolution. | Change from baseline through Final Visit (up to Week 52). |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mack Mabry, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 74036 | La Jolla | California | 92093-0698 | United States | ||
| Site Reference ID/Investigator# 74035 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Los Angeles |
| California |
| 90095-7059 |
| United States |
| Site Reference ID/Investigator# 74038 | Pleasant Hill | California | 94523 | United States |
| Site Reference ID/Investigator# 74039 | Santa Maria | California | 93454 | United States |
| Site Reference ID/Investigator# 74033 | Bethesda | Maryland | 20817 | United States |
| Site Reference ID/Investigator# 79201 | Coburg | 3058 | Australia |
| Site Reference ID/Investigator# 78993 | Greenslopes | 4120 | Australia |
| Site Reference ID/Investigator# 77860 | Afula | 18101 | Israel |
| Site Reference ID/Investigator# 77637 | Rehovot | 76100 | Israel |
| Site Reference ID/Investigator# 77413 | Gdansk | 80-952 | Poland |
| Site Reference ID/Investigator# 79203 | Ivano-Frankivsk | 76008 | Ukraine |
| Site Reference ID/Investigator# 79205 | Khmelnitsky | 29000 | Ukraine |
| Site Reference ID/Investigator# 79202 | Kyiv | 03115 | Ukraine |
| Site Reference ID/Investigator# 79204 | Lviv | 79044 | Ukraine |
| Site Reference ID/Investigator# 79206 | Poltava | 36024 | Ukraine |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C528561 | navitoclax |
Not provided
Not provided
Not provided