A Phase 1-2 XIAP Antisense AEG35156 With Carboplatin and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer

NCT00558922 | Terminated Phase 1

• 1 other identifier: AEG35156-203
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 6

Brief Summary

This is an open-label multicenter, phase 1-2 study. Following determination of the recommended AEG35156 dose in combination with carboplatin and paclitaxel in the initial Phase 1 part of this study, additional patients will be enrolled in the Phase 2 part of the study to assess the activity of the combination in advanced non small cell lung cancer.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Lung; Non small cell; antisense; oligonucleotide; paclitaxel; carboplatin

Outcome Measures

Primary Outcomes (1)

• To determine the recommended dose of AEG35156 when used in combination with carboplatin and paclitaxel and if the dose can enhance the response rate of carboplatin and paclitaxel in patients with advanced non small cell lung cancer.

  2 years

Secondary Outcomes (1)

• To determine progression-free survival.

  2 years

Interventions

AEG35156 DRUG

AEG35156 will be given as a 2-hour intravenous infusion once weekly with a 2-hour loading dose given daily in the 2 days immediately prior to Day 1 (on Days -2 and -1) only in Cycle 1.

Eligibility Criteria

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

You may qualify if:

• Patients with histologically or cytologically confirmed stage IIIB (malignant pleural effusion) or stage IV non small cell lung cancer who are candidates for carboplatin and paclitaxel chemotherapy for metastatic disease
• ECOG performance \< 2
• One or more tumors measurable by RECIST criteria on CT scan or MRI (Phase 2 part only)
• Life expectancy of at least 3 months
• Age \> 18 years
• Signed, written IRB-approved informed consent
• A negative serum pregnancy test (if applicable)
• Acceptable liver function:
• Bilirubin within normal limit
• AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 2.0 times the institution's upper limit of normal
• Acceptable renal function:
• Serum creatinine within normal limits, OR calculated creatinine clearance \> 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• Acceptable hematologic status:
• Granulocyte \> 1500 cells/uL
• Platelet count \> 100,000 plt/uL

You may not qualify if:

• Prior chemotherapy for metastatic disease.
• Patients with prior history of peripheral neuropathy
• Patients with hypersensitivity to platinum containing compounds, mannitol or drugs formulated in Chremophor EL.
• Active progressive brain metastases including the presence of any related symptoms or need for corticosteroids. A CT or MRI scan of the head is necessary in patients with a history of brain metastases to document the stability of prior lesions.
• Known bleeding diathesis
• Pregnant or nursing women. NOTE: Women of child-bearing potential must agree to use adequate contraception (sterile or surgically sterile; hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Men who are unwilling to use acceptable forms of birth control when engaging in sexual contact with women of child bearing potential
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Known infection with HIV, hepatitis B, or hepatitis C
• Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
• Patients who have received any other investigational agent within the last 30 days. Subjects who have used a previous antisense oligonucleotide in the last 90 days will be excluded
• Unwillingness or inability to comply with procedures required in this protocol

Sponsors & Collaborators

• Aegera Therapeutics: lead

Study Sites (6)

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Central Indiana Cancer Center

Indianapolis, Indiana, 46219, United States

Location

Dayton Oncology & Hematology, P.A.

Dayton, Ohio, 45409, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Northwest Cancer Specialists, P. C.

Vancouver, Washington, 98684, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

AEG 35156

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert M Jotte, MD

  Rocky Mountain Cancer Centers

  PRINCIPAL INVESTIGATOR

• Jacques Jolivet, MD, FACP

  Aegera Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 15, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 30, 2009

Record last verified: 2009-07

Locations

US (6)