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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT00732056
First received: August 7, 2008
Last updated: April 11, 2013
Last verified: April 2013
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 24
Study Start Date: July 2008
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Illinois
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
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
ClinicalTrials.gov Identifier: NCT00732056     History of Changes
Other Study ID Numbers: GRN163L CP14A010
Study First Received: August 7, 2008
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014