NCT00558545

Brief Summary

This is an open-label multicenter, phase 1-2 study. Following determination of the recommended AEG35156 dose in combination with weekly 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 breast cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 2, 2009

Status Verified

November 1, 2009

Enrollment Period

1.5 years

First QC Date

November 13, 2007

Last Update Submit

November 30, 2009

Conditions

Human Mammary Carcinoma

Keywords

Breastpaclitaxelantisenseoligonucleotide

Outcome Measures

Primary Outcomes (1)

  • To determine the recommended dose of AEG35156 when used in combination with weekly paclitaxel and at the dose enhance the clinical benefit rate (CBR) of paclitaxel in patients with advanced breast cancer.

    2 years

Secondary Outcomes (2)

  • To determine progression-free survival.

    2 years

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

    2 years

Interventions

AEG35156DRUG

AEG35156 will be given as a 2-hour intravenous infusion once weekly only on weeks when paclitaxel 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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically or cytologically confirmed breast adenocarcinoma who are candidates for paclitaxel single agent chemotherapy for metastatic breast cancer
  • ECOG performance \< 2
  • One or more metastatic tumors measurable by RECIST criteria on CT scan or MRI (Phase 2 part only)
  • Life expectancy of at least 6 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
  • +6 more criteria

You may not qualify if:

  • Prior taxane chemotherapy for metastatic disease.
  • More than one prior chemotherapy regimen for metastatic disease
  • 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
  • Grade \> 2 peripheral neuropathy
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Cancer Centers of Florida, P.A.

Ocoee, Florida, 34761, United States

Location

Central Indiana Cancer Center

Indianapolis, Indiana, 46219, United States

Location

New York Oncology & Hematology P. C., Albany Cancer Center

Albany, New York, 12206, 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

Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Northwest Cancer Specialists, P. C.

Vancouver, Washington, 98684, United States

Location

Related Publications (4)

  • Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106.

    PMID: 16514137BACKGROUND

  • Perez EA, Vogel CL, Irwin DH, Kirshner JJ, Patel R. Multicenter phase II trial of weekly paclitaxel in women with metastatic breast cancer. J Clin Oncol. 2001 Nov 15;19(22):4216-23. doi: 10.1200/JCO.2001.19.22.4216.

    PMID: 11709565BACKGROUND

  • Seidman, A., et al., CALGB 9840: Phase III study of weekly paclitaxel via 1-hour infusion versus standard 3h infusion every third week in the treatment of metastatic breast cancer (MBC), with trastuzumab (T) for HER2 positive MBC and randomized for T in HER2 normal MBC. Proc Am Soc Clin Oncol, 2004. 23: p. 6s.

    BACKGROUND

  • Greenberg PA, Hortobagyi GN, Smith TL, Ziegler LD, Frye DK, Buzdar AU. Long-term follow-up of patients with complete remission following combination chemotherapy for metastatic breast cancer. J Clin Oncol. 1996 Aug;14(8):2197-205. doi: 10.1200/JCO.1996.14.8.2197.

    PMID: 8708708BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

AEG 35156

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David M Loesch, MD

    Central Indiana 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

November 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

December 2, 2009

Record last verified: 2009-11

Locations

US(10)