A Study of MORAb-009 in Subjects With Pancreatic Cancer, Mesothelioma, or Certain Types of Ovarian or Lung Cancer

NCT00325494 | Completed Phase 1

• 1 other identifier: MORAb-009-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to establish the safest doses of an investigational drug called MORAb-009 in subjects with pancreatic cancer, mesothelioma, or certain types of ovarian or lung cancer. MORAb-009 is a monoclonal antibody that is directed to an antigen on the surface of these cancers.

Conditions

Pancreatic Cancer; Mesothelioma; Ovarian Cancer; Non-Small Cell Lung Cancer

Keywords

Pancreatic Cancer; Mesothelioma; Ovarian Cancer; Non-Small Cell Lung Cancer; Mesothelin

Outcome Measures

Primary Outcomes (3)

• Safety and Tolerability as a measure of Adverse Events/Serious Adverse Events

  35 day treatment and observation period, or until disease progession occurs

• Safety and Tolerability as a measure of clinical laboratory parameters

  35 day treatment and observation period, or until disease progession occurs

• Safety and Tolerability as a measure of physical examinations, vital signs, and ECGs

  35 day treatment and observation period, or until disease progession occurs

Secondary Outcomes (3)

• Pharmacokinetics of MORAb-009

  Pre-dose, mid-infusion, end of infusion, 30 min, 60 min, 2 hours, and 4 hours post dose

• Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA])

  35 day treatment and observation period

• Objective Tumor Response Rate Assessed by Investigator

  35 day treatment and observation period

Study Arms (6)

Cohort 1

EXPERIMENTAL

MORAb-009 weekly dose of 12.5 mg/m\^2

Drug: MORAb-009

Cohort 2

EXPERIMENTAL

MORAb-009 weekly dose of 25 mg/m\^2

Drug: MORAb-009

Cohort 3

EXPERIMENTAL

MORAb-009 weekly dose of 50 mg/m\^2

Drug: MORAb-009

Cohort 4

EXPERIMENTAL

MORAb-009 weekly dose of 100 mg/m\^2

Drug: MORAb-009

Cohort 5

EXPERIMENTAL

MORAb-009 weekly dose of 200 mg/m\^2

Drug: MORAb-009

Cohort 6

EXPERIMENTAL

MORAb-009 weekly dose of 400 mg/m\^2

Drug: MORAb-009

Interventions

MORAb-009 DRUG

Each dose of investigational product will be given as a continuous infusion ranging from 12.5 mg/m\^2 up to 400 mg/m\^2.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male subjects, ≥ 18 years of age, with a histologically confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma, or mesothelin-positive ovarian or non-small cell lung cancer. As nearly 100% of pancreatic adenocarcinoma and mesotheliomas express mesothelin, immunohistochemical confirmation of mesothelin-positivity is not necessary.
• Subject must have disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or lesions of less than 2 cm) supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.
• Subject must have failed at least one standard chemotherapy regimen. Patients with pancreatic cancer must have received gemcitabine as part of prior therapy and be considered refractory, or in the case of ovarian cancer be considered platinum refractory or resistant.
• Life expectancy ≥ 3 months, as estimated by the investigator.
• Eastern Cooperative Oncology Group performance status or 0, 1 or 2.
• Female subjects of childbearing potential and all male subjects must consent to use a medically acceptable method of contraception throughout the study period and for 28 days after MORAb-009 administration. A barrier method of contraception must be included.
• Other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to Study Day 1.
• Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count ≥ 100 x 109/L; Hemoglobin ≥ 9 g/dL; Serum bilirubin ≤ 2.0 mg/dL; Aspartate transaminase (AST) ≤ 5 x upper limit of normal (ULN); Alanine transaminase (ALT) ≤ 5 x ULN; Alkaline Phosphatase ≤ 5 x ULN; Serum creatinine ≤ 2.0 mg/dL. If the elevations of liver functions are due to obstruction of the common bile duct extrinsic to the liver, the subject may be enrolled at the discretion of the investigator even if the elevations are greater than the limits above. Stenting to reduce liver functions to qualifying levels is permitted.
• \- Subject must be willing and able to provide written informed consent.

You may not qualify if:

• Known central nervous system (CNS) tumor involvement.
• Evidence of other active malignancy requiring treatment.
• Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).
• ECG demonstrating clinically significant arrhythmias (Note: Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).
• Active serious systemic disease, including active bacterial or fungal infection.
• Active hepatitis or HIV infection.
• Treatment within three months with immunomodulatory therapy (e.g. interferons, immunoglobulin therapy, IL-1RA or systemic corticosteroids). Short term systemic corticosteroids or topical or intra-articular steroids are acceptable, subject to the judgment of the investigator.
• Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to dosing with MORAb-009.
• Breast-feeding, pregnant, or likely to become pregnant during the study.

Sponsors & Collaborators

• Morphotek: lead

Study Sites (3)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

National Cancer Institute

Bethesda, Maryland, 20892-1922, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Mesothelioma; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

amatuximab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Susan C. Weil, M.D.

  Morphotek

  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: May 11, 2006
• First Posted: May 12, 2006
• Study Start: May 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

US (3)