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

Part of paid clinical trials in Santa Monica, California.

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01009073
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ABT-263 — DRUG
    ABT-263 is taken orally. Note - The dose and schedule is variable based on Arm and subject to change based on the toxicities observed.
  • erlotinib — DRUG
    150 mg of erlotinib is taken orally once daily.
  • irinotecan (3-week schedule) — DRUG
    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.
  • irinotecan (weekly schedule) — DRUG
    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.

Study Details

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).

Key Dates

Start date
Oct 31, 2009
Status verified
Jun 2013
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (ABT-263 and erlotinib)
  • Experimental: Arm B (ABT-263 and irinotecan)
  • Experimental: Arm C (ABT-263 monotherapy)

Primary Outcome Measure

Arm A [ Time Frame: Weekly ]

Locations (4)

FacilityCityStateZIPSite coordinators
Site Reference ID/Investigator# 37463Santa MonicaCalifornia90404-
Site Reference ID/Investigator# 36342DetroitMichigan48201-
Site Reference ID/Investigator# 24046San AntonioTexas78229-
Site Reference ID/Investigator# 44917TacomaWashington98405-

Find similar trials in Santa Monica, CA

By research site
Site Reference ID/Investigator# 37463· Santa Monica, CASite Reference ID/Investigator# 36342· Detroit, MISite Reference ID/Investigator# 24046· San Antonio, TXSite Reference ID/Investigator# 44917· Tacoma, WA

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