Know Cancer

or
forgot password

A Phase I/II Study of GRN163L in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

A Phase I/II Study of GRN163L in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer


GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety
of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and
is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in
antineoplastic effects.


Inclusion Criteria:



- Histologically or cytologically confirmed adenocarcinoma of the breast with
measurable locally recurrent or metastatic disease

- May have had one prior non-taxane chemotherapy regimen for metastatic disease

- If HER2 positive, must have had prior treatment with trastuzumab (Herceptin®)

- If previously treated with an anthracycline, anthracenedione, or trastuzumab must be
tested by MUGA scan or echocardiogram and have LVEF ≥ 50%

- Must have recovered from most recent radiation treatment or surgical procedure

- ECOG performance status of 0 or 1

- Life expectancy ≥ 3 months

Exclusion Criteria:

- Locally recurrent disease amenable to resection with curative intent

- Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior to first
study drug administration

- Investigational therapy within 4 weeks prior to first study drug administration

- Prior hormonal therapy within 2 weeks prior to first study drug administration

- Prior radiotherapy within 2 weeks prior to first study drug administration

- Cytotoxic chemotherapy within 2 weeks prior to first study drug administration

- Therapeutic anticoagulation or regular use of anti-platelet therapy within 2 weeks
prior to first study drug administration NOTE: Low-dose anticoagulant therapy to
maintain patency of a vascular access device is allowed.

- Prolongation of PT or INR, aPTT > ULN, or fibrinogen < LLN

- Active or chronically current bleeding (eg, active peptic ulcer)

- Clinically significant cardiovascular or cerebrovascular disease including

Any history of:

- Cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage

- Ischemic bowel

Within the last 12 months:

- MI

- Unstable angina

- NYHA grade II or greater CHF

- Grade 2 or greater peripheral vascular disease

Active at study entry:

- Uncontrolled hypertension defined as SBP > 160 or DBP > 90

- Uncontrolled or clinically significant arrhythmia

- Clinically relevant active infection

- Nonhealing wound or fracture

- Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or
chronic restrictive pulmonary disease

- Active autoimmune disease requiring immunosuppressive therapy

- Known positive serology for HIV

- Prior malignancy (within the last 3 years) except for adequately treated basal cell
or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in
situ prostate cancer, or other cancer for which the patient has been disease-free for
at least 3 years

- Any other severe, acute, or chronic medical or psychiatric condition, laboratory
abnormality, or difficult complying with protocol requirements that may increase the
risk associated with study participation or study drug administration or may
interfere with the interpretation of study results and, in the judgment of the
investigator, would make the patient inappropriate for this study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety, MTD, efficacy

Outcome Time Frame:

First 4 weeks

Safety Issue:

Yes

Principal Investigator

Kathy Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

GRN163L CP14A010

NCT ID:

NCT00732056

Start Date:

July 2008

Completion Date:

March 2012

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Cancer
  • Recurrent Breast Cancer
  • Breast Neoplasms

Name

Location

Ingalls Memorial Hospital Harvey, Illinois  60426
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289