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A Study of ABT-165 in Subjects With Solid Tumors

NCT01946074 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-12-15

No results posted yet for this study

Summary

This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 when administered as monotherapy and in combination with paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B were completed and for Cohorts C and D are recruiting.

Conditions

Interventions

DRUG

paclitaxel

Paclitaxel will be administered by intravenous infusion.

DRUG

FOLFIRI

5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion.

DRUG

ABT-165

ABT-165 will be administered by intravenous infusion at escalating dose levels.

DRUG

ABBV-181

ABBV-181 will be administered by intravenous infusion.

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2013-08-08
Primary Completion
2022-09-28
Completion
2022-09-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01946074 on ClinicalTrials.gov