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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

after four weeks of dosing

Safety Issue:

Yes

Principal Investigator

Mihail Obrocea, MD

Investigator Role:

Study Director

Investigator Affiliation:

Abbott Biotherapeutics Corp.

Authority:

United States: Food and Drug Administration

Study ID:

PDL192-1801

NCT ID:

NCT00738764

Start Date:

July 2008

Completion Date:

October 2011

Related Keywords:

  • Cancer
  • cancer
  • antibody
  • Phase 1 Clinical Trial

Name

Location

Site Reference ID/Investigator# 53365Scottsdale, Arizona  85258
Site Reference ID/Investigator# 53364Aurora, Colorado  80045