Phase 2 N=60 Treatment

A Study of ABT-263 in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00481091 ↗

Enrolled (actual)

Serious AEs

56.7%

Results posted

Jun 2023

Primary outcome: Primary: Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs) — 3; 6; 3; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ABT-263 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)	3; 6; 3; 3; 3; 4	—
PRIMARY Phase 1: Number of Participants With DLTs in the Dose Escalation Phase	0; 1; 0; 2; 0; 1	—
PRIMARY Phase 1: Maximum Tolerated Dose (MTD) in the Dose Escalation Phase	200; 250	—
PRIMARY Phase 1: Recommended Phase 2 Dose (RPTD) Determined in the Dose Escalation Phase	250; 250	—
PRIMARY Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Navitoclax	6.0; 5.9; 6.7; 7.3; 7.3; 6.5	—
PRIMARY Phase 1: Maximum Observed Plasma Concentration (Cmax)	0.25; 1.19; 2.60; 5.19; 2.24; 2.73	—
PRIMARY Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 8 (AUC8)	1.0; 5.7; 10.6; 19.8; 12.0; 12.3	—
PRIMARY Phase 1: Area Under the Plasma Concentration-Time Curve From Time 0 to Hour 24 (AUC24)	2.7; 15.0; 34.0; 67.8; 37.5; 44.0	—
PRIMARY Phase 1: Cmax/Dose	24.5; 10.7; 13.0; 20.8; 17.9; 13.7	—
PRIMARY Phase 1: AUC8/Dose	99.9; 52.0; 53.1; 79.2; 95.8; 61.3	—
PRIMARY Phase 1: AUC24/Dose	268; 136; 170; 271; 300; 220	—
PRIMARY Phase 1: Terminal Phase Elimination Rate Constant (β) for Navitoclax	0.072; 0.077; 0.067; 0.059; 0.066; 0.039	—
PRIMARY Phase 1: Terminal Phase Elimination Half-life (t1/2) of Navitoclax	9.62; 8.99; 10.41; 11.72; 10.51; 17.88	—
PRIMARY Phase 2: Number of Participants With TEAEs, SAEs, and Discontinuations Due to AEs	4; 27; 4; 26; 3; 23	—
PRIMARY Phase 2: Dose-Normalized Plasma Concentrations After Navitoclax Once Daily Dosing	9.49; 9.64; 9.84; 15.2; 9.84; 15.7	—

Summary

The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 under two different dosing schedules with the objective of defining the dose limiting toxicity and maximum tolerated dose. The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy. The Extension Study portion will allow active subjects to continue to receive ABT-263 for up to 11 years after the last subject transitions with less frequent study evaluations.

Eligibility Criteria

Inclusion Criteria

Relapsed or refractory CLL and require treatment in opinion of investigator.
Eastern Cooperative Oncology Group (ECOG) <= 1.
Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria.

Exclusion Criteria

History or is clinically suspicious for cancer-related Central Nervous System disease.
Receipt of allogenic or autologous stem cell transplant.
Recent history (within 1 year of first dose) of underlying, predisposing condition of bleeding or currently exhibits signs of bleeding.
Active peptic ulcer disease or other potentially hemorrhagic esophagitis/gastritis.
Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose).

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Data sourced from ClinicalTrials.gov (NCT00481091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.