Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT01256762 |
Recruitment Status
:
Completed
First Posted
: December 9, 2010
Last Update Posted
: January 26, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Locally Recurrent or Metastatic Breast Cancer | Drug: Imetelstat sodium Drug: Bevacizumab Drug: Paclitaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 166 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
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
|
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01256762

Study Director: | Ted Shih, PharmD | Geron Corporation | |
Principal Investigator: | Kathy Miller, MD | Indiana University School of Medicine |
Publications:
Responsible Party: | Geron Corporation |
ClinicalTrials.gov Identifier: | NCT01256762 History of Changes |
Other Study ID Numbers: |
CP14B014 |
First Posted: | December 9, 2010 Key Record Dates |
Last Update Posted: | January 26, 2016 |
Last Verified: | December 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 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 |