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A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00732056
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Geron Corporation

Tracking Information
First Submitted Date  ICMJE August 7, 2008
First Posted Date  ICMJE August 11, 2008
Last Update Posted Date December 24, 2015
Study Start Date  ICMJE July 2008
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2008)
Safety, MTD, efficacy [ Time Frame: First 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00732056 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2008)
PK and efficacy [ Time Frame: Baseline to end of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer
Official Title  ICMJE A Phase I/II Study of GRN163L in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
Brief Summary 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: GRN163L
25% dose escalation infused over 2 hours weekly
Study Arms  ICMJE Experimental: 1
3+3 cohort dose escalation
Intervention: Drug: GRN163L
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2013)
24
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2008)
35
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00732056
Other Study ID Numbers  ICMJE GRN163L CP14A010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Geron Corporation
Study Sponsor  ICMJE Geron Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathy Miller, MD Indiana University Melvin and Bren Simon Cancer Center
PRS Account Geron Corporation
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP