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Bcl-2 Inhibitor

ABT-263 for Chronic Lymphocytic Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1 day 1: 4-8 h postdose; cycle 1 day 15: predose; cycle 3 day 1: predose, 4-8 h postdose; cycle 5 day 1: predose, 4-8 h postdose; cycle 7 day 1: predose, 4-8 h postdose; cycle 9 day 1: predose, 4-8 h postdose
Awards & highlights

Study Summary

This trial will evaluate the safety and preliminary efficacy of ABT-263, with the objective of enrolling subjects for up to 11 years.

Eligible Conditions
  • Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1: 4-8 h postdose; cycle 1 day 15: predose; cycle 3 day 1: predose, 4-8 h postdose; cycle 5 day 1: predose, 4-8 h postdose; cycle 7 day 1: predose, 4-8 h postdose; cycle 9 day 1: predose, 4-8 h postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1: 4-8 h postdose; cycle 1 day 15: predose; cycle 3 day 1: predose, 4-8 h postdose; cycle 5 day 1: predose, 4-8 h postdose; cycle 7 day 1: predose, 4-8 h postdose; cycle 9 day 1: predose, 4-8 h postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: AUC24/Dose
Phase 1: AUC8/Dose
Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 24 (AUC24)
+12 more

Side effects data

From 2022 Phase 1 & 2 trial • 60 Patients • NCT00481091
75%
DIARRHOEA
50%
VOMITING
50%
COUGH
50%
HERPES SIMPLEX
50%
NAUSEA
50%
FATIGUE
50%
UPPER RESPIRATORY TRACT INFECTION
50%
DECREASED APPETITE
25%
NEURALGIA
25%
PRODUCTIVE COUGH
25%
GASTROENTERITIS SALMONELLA
25%
LYMPHADENOPATHY
25%
VENTRICULAR EXTRASYSTOLES
25%
NEUTROPENIA
25%
PYREXIA
25%
ABDOMINAL PAIN
25%
CONSTIPATION
25%
EYE INFECTION
25%
CELLULITIS
25%
PNEUMONITIS
25%
SUPERFICIAL SPREADING MELANOMA STAGE UNSPECIFIED
25%
THROMBOCYTOPENIA
25%
INFLUENZA LIKE ILLNESS
25%
VIRAL INFECTION
25%
NASOPHARYNGITIS
25%
ORAL HERPES
25%
CONTUSION
25%
DEHYDRATION
25%
LIMB DISCOMFORT
25%
NEUROPATHY PERIPHERAL
25%
DYSPNOEA
25%
LETHARGY
25%
SINUS CONGESTION
25%
WHEEZING
25%
COLD SWEAT
25%
LOWER RESPIRATORY TRACT INFECTION
25%
DYSPEPSIA
25%
CHEST PAIN
25%
FEELING HOT
25%
OEDEMA PERIPHERAL
25%
HYPOMAGNESAEMIA
25%
SECRETION DISCHARGE
25%
ALLERGY TO ARTHROPOD BITE
25%
INFLUENZA
25%
SINUSITIS
25%
BACK PAIN
25%
OSTEOPENIA
25%
BASAL CELL CARCINOMA
25%
SQUAMOUS CELL CARCINOMA OF SKIN
25%
HEADACHE
25%
OROPHARYNGEAL PAIN
25%
SKIN LESION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Navitoclax 21/21 Day Cycle: 200 mg
Phase 2: Navitoclax 100 mg
Navitoclax 14/21 Day Cycle: 200 mg
Navitoclax 21/21 Day Cycle: 125 mg
Navitoclax 14/21 Day Cycle: 250 mg
Navitoclax 21/21 Day Cycle: 250 mg
Phase 2: Navitoclax 250 mg
Navitoclax 21/21 Day Cycle: 300 mg
Navitoclax 14/21 Day Cycle: 10 mg
Navitoclax 14/21 Day Cycle: 110 mg

Trial Design

10Treatment groups
Experimental Treatment
Group I: Phase 2: Navitoclax 250 mgExperimental Treatment1 Intervention
Navitoclax 250 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).
Group II: Phase 2: Navitoclax 100 mgExperimental Treatment1 Intervention
Navitoclax 100 mg in participants with CLL who had relapsed following any (but no more than 5) prior myelosuppressive/chemotherapy treatment regimen(s).
Group III: Navitoclax 21/21 Day Cycle: 300 mgExperimental Treatment1 Intervention
Navitoclax 300 mg administered for 21 consecutive days to complete a 21-day cycle.
Group IV: Navitoclax 21/21 Day Cycle: 250 mgExperimental Treatment1 Intervention
Navitoclax 250 mg administered for 21 consecutive days to complete a 21-day cycle.
Group V: Navitoclax 21/21 Day Cycle: 200 mgExperimental Treatment1 Intervention
Navitoclax 200 mg administered for 21 consecutive days to complete a 21-day cycle.
Group VI: Navitoclax 21/21 Day Cycle: 125 mgExperimental Treatment1 Intervention
Navitoclax 125 mg administered for 21 consecutive days to complete a 21-day cycle.
Group VII: Navitoclax 14/21 Day Cycle: 250 mgExperimental Treatment1 Intervention
Navitoclax 250 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
Group VIII: Navitoclax 14/21 Day Cycle: 200 mgExperimental Treatment1 Intervention
Navitoclax 200 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
Group IX: Navitoclax 14/21 Day Cycle: 110 mgExperimental Treatment1 Intervention
Navitoclax 110 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
Group X: Navitoclax 14/21 Day Cycle: 10 mgExperimental Treatment1 Intervention
Navitoclax 10 mg administered for 14 consecutive days followed by 7 days off drug to complete a 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABT-263
2008
Completed Phase 2
~690

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,335 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,869 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,497 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
2007. "A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00481091.
~3 spots leftby Apr 2025
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