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

• ClinicalTrials.gov Identifier: NCT00732056
• Recruitment Status: Completed
• First Posted: August 11, 2008
• Last Update Posted: December 24, 2015
• Sponsor: Geron Corporation
• Information provided by (Responsible Party): Geron Corporation

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: GRN163L	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: July 2008
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 3+3 cohort dose escalation	Drug: GRN163L; 25% dose escalation infused over 2 hours weekly

Outcome Measures

Primary Outcome Measures :

1. Safety, MTD, efficacy [ Time Frame: First 4 weeks ]

Secondary Outcome Measures :

1. PK and efficacy [ Time Frame: Baseline to end of treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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:

Related Info 

• Responsible Party: Geron Corporation
• ClinicalTrials.gov Identifier: NCT00732056
• Other Study ID Numbers: GRN163L CP14A010
• First Posted: August 11, 2008
• Last Update Posted: December 24, 2015
• Last Verified: December 2015

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