Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)

NCT01557777 | Completed Phase 2

• 2 other identifiers: M13-6412012-000606-29
• Study Type: interventional
• Target: 17
• Locations: 5 countries
• Sites: 15

Brief Summary

Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (3)

• 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).

Study Arms (1)

Navitoclax, ABT-263

EXPERIMENTAL

Drug: Navitoclax

Interventions

Navitoclax DRUG

QD

Also known as: ABT-263

Navitoclax, ABT-263

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject has been dosing in Arm C of the ABT4710n study, has not discontinued for any reason prior to study closure and the investigator believes that continued treatment with navitoclax is in the best interest of the subject
• The subject must meet defined hematology and coagulation lab criteria as specified in the protocol
• The subject must meet defined chemistry criteria as specified in the protocol
• Women of childbearing potential and men must agree to use adequate contraception (as per protocol) prior to study entry, for the duration of study participation and up to 90 days following completion of therapy
• The subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign the Informed Consent Form

You may not qualify if:

• The subject discontinued navitoclax administration in Arm C of the ABT4710n study for reasons of disease progression, Adverse Event toxicity, withdrawal of consent or Investigator decision prior to study completion.
• The subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
• The subject is a lactating or pregnant female.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (15)

Site Reference ID/Investigator# 74036

La Jolla, California, 92093-0698, United States

Location

Site Reference ID/Investigator# 74035

Los Angeles, California, 90095-7059, United States

Location

Site Reference ID/Investigator# 74038

Pleasant Hill, California, 94523, United States

Location

Site Reference ID/Investigator# 74039

Santa Maria, California, 93454, United States

Location

Site Reference ID/Investigator# 74033

Bethesda, Maryland, 20817, United States

Location

Site Reference ID/Investigator# 79201

Coburg, 3058, Australia

Location

Site Reference ID/Investigator# 78993

Greenslopes, 4120, Australia

Location

Site Reference ID/Investigator# 77860

Afula, 18101, Israel

Location

Site Reference ID/Investigator# 77637

Rehovot, 76100, Israel

Location

Site Reference ID/Investigator# 77413

Gdansk, 80-952, Poland

Location

Site Reference ID/Investigator# 79203

Ivano-Frankivsk, 76008, Ukraine

Location

Site Reference ID/Investigator# 79205

Khmelnitsky, 29000, Ukraine

Location

Site Reference ID/Investigator# 79202

Kyiv, 03115, Ukraine

Location

Site Reference ID/Investigator# 79204

Lviv, 79044, Ukraine

Location

Site Reference ID/Investigator# 79206

Poltava, 36024, Ukraine

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

navitoclax

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mack Mabry, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 20, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 4, 2014

Record last verified: 2014-07

Locations

IL (2); PL (1); US (5); UA (5); AU (2)