A Phase 1-2, XIAP Antisense AEG35156 With Gemcitabine in Patients With Advanced Pancreatic Cancer

NCT00557596 | Terminated Phase 1

• 1 other identifier: AEG35156-201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

This is an open-label multicenter, phase 1-2 study. Following determination of the recommended AEG35156 dose in combination with gemcitabine 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 first-line in advanced pancreatic cancer.

Conditions

Carcinoma; Pancreas

Keywords

Pancreatic; antisense; oligonucleotide; gemcitabine

Outcome Measures

Primary Outcomes (1)

• To determine the recommended dose of AEG35156 when used in combination with gemcitabine and the change in response rate of gemcitabine in patients

  1 year

Secondary Outcomes (2)

• To determine progression-free survival.

  2 years

• To establish the pharmacokinetics of AEG35156 and gemcitabine when used in combination.

  1 year

Interventions

AEG35156 DRUG

AEG35156 will be given as a 2-hour intravenous infusion once weekly, only on weeks when gemcitabine is administered, 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 advanced pancreatic adenocarcinoma who are candidates for first-line gemcitabine therapy
• Karnofsky performance \>70%
• One or more metastatic 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 \< 1.5 times the institution's upper limit of normal
• AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 2.5 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 pancreatic cancer, except for 5-fluorouracil or gemcitabine given as a radiosensitizer
• 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 or concurrent treatment with anticoagulants except patients on non-therapeutic line maintenance coumadin
• 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 are currently receiving any other investigational agent. 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 (4)

Scottsdale Healthcare - SHEA

Scottsdale, Arizona, 85258, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Arizona Cancer Center - University of Arizona

Tucson, Arizona, 85724, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

MeSH Terms

Conditions

Carcinoma

Interventions

AEG 35156

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Daniel D Von Hoff, MD, FACP

  TGen Clinical Research Services at Scottsdale Healthcare

  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 14, 2007
• Study Start: September 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

US (4)