- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00732056
A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer
December 22, 2015 updated by: Geron Corporation
A Phase I/II Study of GRN163L in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
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)
Study Overview
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
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Harvey, Illinois, United States, 60426
- Ingalls Memorial Hospital
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Melvin and Bren Simon Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
3+3 cohort dose escalation
|
25% dose escalation infused over 2 hours weekly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety, MTD, efficacy
Time Frame: First 4 weeks
|
First 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PK and efficacy
Time Frame: Baseline to end of treatment
|
Baseline to end of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathy Miller, MD, Indiana University Melvin and Bren Simon Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
August 7, 2008
First Submitted That Met QC Criteria
August 8, 2008
First Posted (Estimate)
August 11, 2008
Study Record Updates
Last Update Posted (Estimate)
December 24, 2015
Last Update Submitted That Met QC Criteria
December 22, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GRN163L CP14A010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on GRN163L
-
Geron CorporationCompletedChronic Lymphoproliferative DiseasesUnited States
-
Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI)TerminatedGlioblastoma | Gliosarcoma | Ependymoma | Anaplastic Astrocytoma | Oligodendroglioma | Anaplastic Ependymoma | Giant Cell Glioblastoma | Astrocytoma, Grade II | Brainstem TumorsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnRhabdomyosarcoma | Recurrent Neuroblastoma | Recurrent Osteosarcoma | Hepatoblastoma | Recurrent Childhood Rhabdomyosarcoma | Previously Treated Childhood Rhabdomyosarcoma | Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Recurrent Childhood Liver Cancer
-
Geron CorporationCompletedPrimary Myelofibrosis | Secondary Myelofibrosis | Myeloid MalignanciesUnited States
-
Geron CorporationRecruiting
-
Geron CorporationActive, not recruitingMyelodysplastic SyndromesUnited States, Canada, Belgium, Spain, Czechia, Korea, Republic of, United Kingdom, Netherlands, Israel, Germany, Russian Federation, Switzerland, Italy, France, Turkey, Poland, Ukraine
-
GCP-Service International West GmbHSaint-Louis Hospital, Paris, France; Groupe Francophone des Myelodysplasies; Australasian... and other collaboratorsRecruitingAcute Myeloid Leukemia | Myelodysplastic SyndromesAustralia, France, Germany
-
Geron CorporationCompletedMultiple MyelomaUnited States
-
Geron CorporationCompletedSolid Tumor MalignanciesUnited States
-
Geron CorporationCompleted