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

Sponsor
Geron Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00732056
Collaborator
(none)
24
Enrollment
2
Locations
1
Arm
44
Duration (Months)
12
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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
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
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 :
Jul 1, 2008
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Mar 1, 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 [First 4 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Ingalls Memorial Hospital Harvey Illinois United States 60426
2 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Geron Corporation
ClinicalTrials.gov Identifier:
NCT00732056
Other Study ID Numbers:
  • GRN163L CP14A010
First Posted:
Aug 11, 2008
Last Update Posted:
Dec 24, 2015
Last Verified:
Dec 1, 2015
Keywords provided by Geron Corporation
Metastatic Breast Cancer
Recurrent Breast Cancer
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Dec 24, 2015