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A Phase 1-2, Multicenter, Open-Label Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With Weekly Paclitaxel in Patients With Advanced Breast Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Human Mammary Carcinoma

Thank you

Trial Information

A Phase 1-2, Multicenter, Open-Label Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination With Weekly Paclitaxel in Patients With Advanced Breast Cancer

Breast cancer is the most common cancer in women in the United States, the second most
common cause of cancer death, and the main cause of death in women ages 45 to 55. In 2006,
212,920 American women will be diagnosed with breast cancer, and 40,970 will die from this
disease.[1]. Fewer than 10 percent of women present with metastatic disease at the time of
diagnosis. However, the majority of women who relapse after initial definitive therapy for
early stage or locally advanced disease will do so with disseminated metastatic disease
rather than an isolated local recurrence. Treatment for metastatic disease is palliative in
intent and will usually involve hormone therapy and/or chemotherapy with or without
trastuzumab. Active chemotherapy agents include anthracyclines, taxanes, vinorelbine,
alkylating agents and antimetabolites. Taxanes have become the cornerstone of first-line
treatment for metastatic breast cancer. Weekly doses of paclitaxel can be administered
continuously for several weeks with a remarkable lack of myelosuppression [2]. Weekly
paclitaxel (80 mg/m2) was directly compared to every three-week therapy (175 mg/m2) in 585
women with metastatic breast cancer. Weekly therapy was associated with a significantly
higher response rate (40 versus 28 percent) and longer TTP (nine versus five months), but
similar overall survival and worse neurotoxicity [3]. Since patients with metastatic breast
cancer are unlikely to be cured of their disease [4], they should be considered candidates
for a clinical trial.

Inclusion Criteria:

- 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

- Hemoglobin > 9.0 g/dL

- Acceptable coagulation status:

- PT within normal limits

- PTT within normal limits

- For women of child-bearing potential, the use of effective contraceptive methods
during the study

- Prior radiotherapy is allowed provided disease progression outside the radiation
field has been documented, and treatment completed at least 2 weeks prior to

Exclusion Criteria:

- 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

- 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

- Any deviation from these inclusion/exclusion criteria must be discussed with the
sponsor prior to enrolling patient.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

David M Loesch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Central Indiana Cancer Centers


United States: Food and Drug Administration

Study ID:




Start Date:

November 2007

Completion Date:

May 2009

Related Keywords:

  • Human Mammary Carcinoma
  • Breast
  • paclitaxel
  • antisense
  • oligonucleotide
  • Breast Neoplasms
  • Carcinoma



Virginia Oncology Associates Newport News, Virginia  23606
Rocky Mountain Cancer Center Denver, Colorado  80218
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Tyler Cancer Center Tyler, Texas  75702
Cancer Centers of Florida, P.A. Orlando, Florida  
Central indiana Cancer Center Indianapolis, Indiana  46227
Sammons Cancer Center Dallas, Texas  
Dayton Oncology & Hematology, P.A. Kettering, Ohio  45409
New York Oncology & Hematology P. C., Albany Cancer Center Albany, New York  12206
Northwest Cancer Specialists, P. C. Vancouver, Washington  98684