A Trial of PDL192 in Subjects With Advanced Solid Tumors

Cancer Clinical Trial

Official title:

A Phase 1, Multicenter, Open-Label, Dose Escalation Trial of PDL192 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738764
• Other study ID #: PDL192-1801
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2008
• Last updated: January 5, 2012
• Start date: July 2008
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Biological:
• PDL192
Humanized anti-TWEAK receptor monoclonal IgG1 antibody

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 53364	Aurora	Colorado
United States	Site Reference ID/Investigator# 53365	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		after four weeks of dosing	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	Incidence of PDL192-specific antidrug antibodies		during estimated average 4 month treatment period and 90 day follow up	No
Secondary	Objective response rate (Complete Response + Partial Response) and Disease control rate (Complete Response + Partial Response + Stable Disease)		during estimated average 4 month treatment period	No