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Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
This study has been completed.
Sponsor:
Geron Corporation
Information provided by (Responsible Party):
Geron Corporation
ClinicalTrials.gov Identifier:
NCT01256762
First received: December 2, 2010
Last updated: December 22, 2015
Last verified: December 2015
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Purpose
The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have not received chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Locally Recurrent or Metastatic Breast Cancer | Drug: Imetelstat sodium Drug: Bevacizumab Drug: Paclitaxel | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase II Study Of Imetelstat (GRN163L) In Combination With Paclitaxel (With Or Without Bevacizumab) in Patients With Locally Recurrent Or Metastatic Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
Further study details as provided by Geron Corporation:
Primary Outcome Measures:
- Progression-free survival [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ]Defined as the time from randomization to documented disease progression, as determined by the investigator's assessment according to RECIST, or death from any cause, whichever occurs first.
Secondary Outcome Measures:
- Objective response [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ]Objective response as determined by the investigator according to RECIST for patients with measurable disease at baseline.
- Clinical benefit rate [ Time Frame: Occurring post randomization through end of study period (9 mos. after the last participant is randomized) ]Clinical response rate includes patients with objective response and stable disease lasting at least 6 months.
| Enrollment: | 166 |
| Study Start Date: | November 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Imetelstat + Paclitaxel (with or without bevacizumab) |
Drug: Imetelstat sodium
Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.
Other Name: GRN163L
Drug: Bevacizumab
Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
Other Name: Avastin
Drug: Paclitaxel
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Other Name: Taxol
|
| Experimental: Paclitaxel (with or without bevacizumab) alone |
Drug: Bevacizumab
Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
Other Name: Avastin
Drug: Paclitaxel
Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
Other Name: Taxol
|
Detailed Description:
Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the breast that is either locally recurrent or metastatic. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent
- Either have not received chemotherapy or may have had one prior non-taxane chemotherapy regimen for metastatic disease (there are no restrictions on prior hormonal therapy)
- Prior use of bevacizumab is allowed provided that it was not administered in combination with a taxane
- ECOG performance status 0-1
-
Adequate bone marrow reserve as indicated by:
- ANC > 1500/uL (without use of growth factors within 7 days)
- Platelet count > 100,000 (without transfusion in prior 7 days)
- Hemoglobin > 9.0 g/dL
Exclusion Criteria:
- Women who are pregnant or breast feeding
- Locally recurrent disease amenable to resection with curative intent
- HER-2-positive breast cancer
- Active central nervous system (CNS) metastatic disease including those patients receiving radiotherapy and/or steroid treatment (within the last 3 months)
- Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior of first relapse
- Investigational therapy within 4 weeks of first study drug administration
- Prior radiation, cytotoxic, or hormonal therapy within 2 weeks of first study drug administration
- Therapeutic anti-coagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration (low dose anti-coagulant therapy to maintain patency of a vascular access device is allowed)
- Grade ≥ 2 neuropathy
- Uncontrolled clinically significant atrial or ventricular arrhythmias (unless pacemaker in place)
- Severe conduction disturbance including clinically significant QTC prolongation > 450 ms (unless pacemaker in place)
- Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
- Clinically relevant active infection
- Known positive serology for human immunodeficiency virus (HIV)
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: NCT01256762
Show 55 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256762
Show 55 Study Locations
Sponsors and Collaborators
Geron Corporation
Investigators
| Study Director: | Ted Shih, PharmD | Geron Corporation |
| Principal Investigator: | Kathy Miller, MD | Indiana University School of Medicine |
More Information
Publications:
| Responsible Party: | Geron Corporation |
| ClinicalTrials.gov Identifier: | NCT01256762 History of Changes |
| Other Study ID Numbers: |
CP14B014 |
| Study First Received: | December 2, 2010 |
| Last Updated: | December 22, 2015 |
Keywords provided by Geron Corporation:
|
imetelstat imetelstat sodium GRN163L telomerase inhibitor telomerase inhibition metastatic breast cancer locally recurrent breast cancer |
Bevacizumab Paclitaxel Avastin Taxol HER-2-negative First-Line Chemotherapy Second-Line Chemotherapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Albumin-Bound Paclitaxel Bevacizumab Niacinamide Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Vitamin B Complex Vitamins Micronutrients |
ClinicalTrials.gov processed this record on June 23, 2017