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A Study Evaluating ABT-263 With Erlotinib, ABT-263 With Irinotecan, and ABT-263 Monotherapy in Cancer Subjects

NCT01009073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-11-20

No results posted yet for this study

Summary

This is a three arm study to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with erlotinib (Arm A), to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with irinotecan (Arm B), and to evaluate safety of ABT-263 monotherapy (Arm C).

Conditions

Interventions

DRUG

ABT-263

ABT-263 is taken orally. Note - The dose and schedule is variable based on Arm and subject to change based on the toxicities observed.

DRUG

erlotinib

150 mg of erlotinib is taken orally once daily.

DRUG

irinotecan (3-week schedule)

180 mg/m2 over 90 minutes, irinotecan will be given by intravenous infusion on Day 1 of each 21 day cycle. Note - The dose and schedule is subject to change based on the toxicities observed.

DRUG

irinotecan (weekly schedule)

75 mg/m2 over 45 minutes, irinotecan will be given by intravenous infusion on Days 1 and 8 of each 21 day cycle. Note - The dose and schedule is subject to change based on the toxicities observed.

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Kyle Holen · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01009073 on ClinicalTrials.gov