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A Trial of PDL192 in Subjects With Advanced Solid Tumors

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT00738764
Collaborator
(none)
30
Enrollment
2
Locations
6
Arms
39
Duration (Months)
15
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: PDL192
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Multicenter, Open-Label, Dose Escalation Trial of PDL192 in Subjects With Advanced Solid Tumors
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

PDL192 Dose Level 1

Biological: PDL192
Humanized anti-TWEAK receptor monoclonal IgG1 antibody
Experimental: Cohort 2

PDL192 Dose Level 2

Biological: PDL192
Humanized anti-TWEAK receptor monoclonal IgG1 antibody
Experimental: Cohort 3

PDL192 Dose Level 3

Biological: PDL192
Humanized anti-TWEAK receptor monoclonal IgG1 antibody
Experimental: Cohort 4

PDL192 Dose Level 4

Biological: PDL192
Humanized anti-TWEAK receptor monoclonal IgG1 antibody
Experimental: Cohort 5

PDL192 Dose Level 5

Biological: PDL192
Humanized anti-TWEAK receptor monoclonal IgG1 antibody
Experimental: Cohort 6

PDL192 Dose Level 6

Biological: PDL192
Humanized anti-TWEAK receptor monoclonal IgG1 antibody

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerated dose [after four weeks of dosing]

Secondary Outcome Measures

  1. 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]

  2. 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]

  3. Incidence of PDL192-specific antidrug antibodies [during estimated average 4 month treatment period and 90 day follow up]

  4. Objective response rate (Complete Response + Partial Response) and Disease control rate (Complete Response + Partial Response + Stable Disease) [during estimated average 4 month treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion Criteria

Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:

  1. Male or female, 18 years of age or older.

  2. Subjects with documented advanced solid tumors.

  3. Subjects who have previously failed all standard therapies or subjects who have a tumor where no standard therapy exists.

  4. 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.

  5. 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).

Exclusion Criteria

Subjects will be ineligible for this study if they meet any one of the following criteria:

  1. Symptomatic and progressive central nervous system (CNS) metastases or leptomeningeal metastases

  2. Diagnosis of glioblastoma

  3. Eastern Cooperative Oncology Group (ECOG) performance status >= 2

  4. Abnormal hematologic values defined as:

  • Hemoglobin level < 9 g/dL

  • Absolute neutrophil count (ANC) < 1500/mm3

  • Platelet count < 100,000/mm3

  1. 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

  1. Known chronic viral hepatitis

  2. History of cirrhotic liver disease

  3. History of pancreatitis (patients with history of gall stone pancreatitis who are status post-cholecystectomy will be eligible)

  4. Acute cholecystitis within 6 months prior to the first dose of study drug

  5. Treatment with any investigational drug, antineoplastic agent, or antibodies within 21 days prior to the first dose of study drug (6 weeks for vaccines or nitrosureas)

  6. Proteinuria >1 g/24 hours (only subjects with > = 2+ with dipstick test will undergo 24 hour urine collection)

  7. Ongoing >= Grade 2 toxicities resulting from prior therapies

  8. Received continuous systemic steroids at doses greater than 10 mg/day of prednisone or its equivalent within 30 days prior to the first dose of study drug (intermittent dexamethasone given for prophylaxis or treatment of emesis is permitted)

  9. Received any immunosuppressive agent (except steroids) within 21 days prior to the first dose of study drug

  10. Known hypersensitivity to any component of the PDL192 formulation

  11. Uncontrolled medical problems such as diabetes mellitus, pancreatitis, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary disease, or symptomatic heart failure

  12. Female subjects who are pregnant or breastfeeding

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site Reference ID/Investigator# 53365 Scottsdale Arizona United States 85258
2 Site Reference ID/Investigator# 53364 Aurora Colorado United States 80045

Sponsors and Collaborators

  • Abbott

Investigators

  • Study Director: Mihail Obrocea, MD, Abbott Biotherapeutics Corp.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abbott
ClinicalTrials.gov Identifier:
NCT00738764
Other Study ID Numbers:
  • PDL192-1801
First Posted:
Aug 20, 2008
Last Update Posted:
Jan 6, 2012
Last Verified:
Dec 1, 2011
Keywords provided by Abbott
cancer
antibody
Phase 1 Clinical Trial

Study Results

No Results Posted as of Jan 6, 2012