A Trial of PDL192 in Subjects With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00738764
First received: August 18, 2008
Last updated: January 5, 2012
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Cancer
Biological: PDL192
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-Label, Dose Escalation Trial of PDL192 in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: after four weeks of dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: during estimated average 4 month treatment period and 90 day follow up ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: during estimated average 4 month treatment period and 90 day follow up ] [ Designated as safety issue: No ]
  • Incidence of PDL192-specific antidrug antibodies [ Time Frame: during estimated average 4 month treatment period and 90 day follow up ] [ Designated as safety issue: No ]
  • Objective response rate (Complete Response + Partial Response) and Disease control rate (Complete Response + Partial Response + Stable Disease) [ Time Frame: during estimated average 4 month treatment period ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  5. 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
  6. Known chronic viral hepatitis
  7. History of cirrhotic liver disease
  8. History of pancreatitis (patients with history of gall stone pancreatitis who are status post-cholecystectomy will be eligible)
  9. Acute cholecystitis within 6 months prior to the first dose of study drug
  10. 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)
  11. Proteinuria >1 g/24 hours (only subjects with > = 2+ with dipstick test will undergo 24 hour urine collection)
  12. Ongoing >= Grade 2 toxicities resulting from prior therapies
  13. 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)
  14. Received any immunosuppressive agent (except steroids) within 21 days prior to the first dose of study drug
  15. Known hypersensitivity to any component of the PDL192 formulation
  16. Uncontrolled medical problems such as diabetes mellitus, pancreatitis, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary disease, or symptomatic heart failure
  17. Female subjects who are pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738764

Locations
United States, Arizona
Site Reference ID/Investigator# 53365
Scottsdale, Arizona, United States, 85258
United States, Colorado
Site Reference ID/Investigator# 53364
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Abbott
Investigators
Study Director: Mihail Obrocea, MD Abbott Biotherapeutics Corp.
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00738764     History of Changes
Other Study ID Numbers: PDL192-1801
Study First Received: August 18, 2008
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
cancer
antibody
Phase 1 Clinical Trial

ClinicalTrials.gov processed this record on October 23, 2014