A Trial of PDL192 in Subjects With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Cancer
• Interventions: Biological: PDL192

• Registration Number: NCT00738764
• Lead Sponsor: Abbott

Brief Summary

This is a phase 1, multicenter, open-label, dose escalation trial of PDL192 in subjects with advanced solid tumors.

Detailed Description

The primary study objective is to determine the maximum tolerated dose of PDL192 in subjects with advanced solid tumors.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-12
• Last Update Submitted: 2012-01-05
• Last Update Posted: 2012-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 4	PDL192	PDL192 Dose Level 4
Cohort 5	PDL192	PDL192 Dose Level 5
Cohort 1	PDL192	PDL192 Dose Level 1
Cohort 2	PDL192	PDL192 Dose Level 2
Cohort 3	PDL192	PDL192 Dose Level 3
Cohort 6	PDL192	PDL192 Dose Level 6

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	after four weeks of dosing

Secondary Outcome Measures

Name	Time	Method
The incidence and frequency of dose-limiting toxicities; The frequency, severity, and relationship of adverse events and serious adverse events;Incidence of abnormal findings in physical examinations and clinical laboratory values	during estimated average 4 month treatment period and 90 day follow up
Pharmacokinetic profile of PDL192 including maximum serum drug concentration, area under the concentration-time curve from time zero to infinity, systemic clearance, volume of distribution, and elimination half-life	during estimated average 4 month treatment period and 90 day follow up
Incidence of PDL192-specific antidrug antibodies	during estimated average 4 month treatment period and 90 day follow up
Objective response rate (Complete Response + Partial Response) and Disease control rate (Complete Response + Partial Response + Stable Disease)	during estimated average 4 month treatment period

Trial Locations

Locations (2)

Site Reference ID/Investigator# 53365; 🇺🇸 Scottsdale, Arizona, United States

Site Reference ID/Investigator# 53364; 🇺🇸 Aurora, Colorado, United States