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A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by Geron Corporation, May 2009
First Received: August 7, 2008   Last Updated: May 27, 2009   History of Changes
Sponsored by: Geron Corporation
Information provided by: Geron Corporation
ClinicalTrials.gov Identifier: NCT00732056
  Purpose

The purpose of this study is to determine the maximum tolerated dose (MTD) of GRN163L in combination with paclitaxel and bevacizumab in patients with locally recurrent or metastatic breast cancer (MBC)


Condition Intervention Phase
Breast Cancer
Drug: GRN163L
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
Official Title: A Phase I/II Study of GRN163L in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Geron Corporation:

Primary Outcome Measures:
  • Safety, MTD, efficacy [ Time Frame: First 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PK and efficacy [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: July 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
3+3 cohort dose escalation
Drug: GRN163L
25% dose escalation infused over 2 hours weekly

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732056

Contacts
Contact: David Rhodes (650) 566-7205 drhodes@geron.com

Locations
United States, Illinois
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Patricia Gowland     708-915-6849     PGOWLAND@ingalls.org    
Principal Investigator: Mark Kozloff, MD            
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Shonkwiler     317-278-7792     jenshonk@iupui.edu    
Principal Investigator: Kathy Miller, MD            
Sponsors and Collaborators
Geron Corporation
Investigators
Principal Investigator: Kathy Miller, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Geron Corporation ( Fabio Benedetti, MD )
Study ID Numbers: GRN163L CP14A010
Study First Received: August 7, 2008
Last Updated: May 27, 2009
ClinicalTrials.gov Identifier: NCT00732056     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Geron Corporation:
Metastatic Breast Cancer
Recurrent Breast Cancer

Study placed in the following topic categories:
Skin Diseases
Paclitaxel
Breast Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Skin Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Breast Neoplasms
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on August 26, 2009