NCT00738764

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Jul 2008

Typical duration for phase_1 cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 6, 2012

Status Verified

December 1, 2011

Enrollment Period

3.3 years

First QC Date

August 18, 2008

Last Update Submit

January 5, 2012

Conditions

Cancer

Keywords

cancerantibodyPhase 1 Clinical Trial

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    after four weeks of dosing

Secondary Outcomes (4)

  • 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

Study Arms (6)

Cohort 1

EXPERIMENTAL

PDL192 Dose Level 1

Biological: PDL192

Cohort 2

EXPERIMENTAL

PDL192 Dose Level 2

Biological: PDL192

Cohort 3

EXPERIMENTAL

PDL192 Dose Level 3

Biological: PDL192

Cohort 4

EXPERIMENTAL

PDL192 Dose Level 4

Biological: PDL192

Cohort 5

EXPERIMENTAL

PDL192 Dose Level 5

Biological: PDL192

Cohort 6

EXPERIMENTAL

PDL192 Dose Level 6

Biological: PDL192

Interventions

PDL192BIOLOGICAL

Humanized anti-TWEAK receptor monoclonal IgG1 antibody

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Cohort 6

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 years of age or older.
  • Subjects with documented advanced solid tumors.
  • Subjects who have previously failed all standard therapies or subjects who have a tumor where no standard therapy exists.
  • A negative serum pregnancy test (women of childbearing potential only) at screening. Male or female subjects of reproductive potential must be willing to use adequate contraception during the duration of the study and for a minimum of 3 months after the end of treatment.
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).

You may not qualify if:

  • Subjects will be ineligible for this study if they meet any one of the following criteria:
  • Symptomatic and progressive central nervous system (CNS) metastases or leptomeningeal metastases
  • Diagnosis of glioblastoma
  • Eastern Cooperative Oncology Group (ECOG) performance status \>= 2
  • Abnormal hematologic values defined as:
  • Hemoglobin level \< 9 g/dL
  • Absolute neutrophil count (ANC) \< 1500/mm3
  • Platelet count \< 100,000/mm3
  • Abnormal kidney, liver, or pancreatic function defined as:
  • Serum creatinine \> 1.5 x upper limit of normal value (ULN)
  • Aspartate transaminase or alanine transaminase levels of \> = 2.5 x ULN
  • Bilirubin \> ULN
  • Amylase \> 1.5 x ULN
  • Lipase \> 1.5 x ULN
  • Known chronic viral hepatitis
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site Reference ID/Investigator# 53365

Scottsdale, Arizona, 85258, United States

Location

Site Reference ID/Investigator# 53364

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

enavatuzumab

Study Officials

  • Mihail Obrocea, MD

    Abbott Biotherapeutics Corp.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 6, 2012

Record last verified: 2011-12

Locations

US(2)