Locally Recurrent or Metastatic Breast Cancer Clinical Trial
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
| Verified date | December 2015 |
| Source | Geron Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 166 |
| Est. completion date | December 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Grand River Regional Cancer Centre | Kitchener | Ontario |
| Canada | McGill University | Montreal | Quebec |
| Canada | Stronach Regional Cancer Centre at Southlake | Newmarket | Ontario |
| Canada | The Ottawa Hospital Cancer Centre | Ottawa | Ontario |
| Canada | Sunnybrook Health Services Centre | Toronto | Ontario |
| United States | New Mexico Cancer Center | Albuquerque | New Mexico |
| United States | Northeast Georgia Cancer Care | Athens | Georgia |
| United States | Emory University | Atlanta | Georgia |
| United States | Peachtree Hematology Oncology | Atlanta | Georgia |
| United States | Univ. Colorado at Denver | Aurora | Colorado |
| United States | Alta Bates Summit Medical Center | Berkeley | California |
| United States | Southbay Oncology Hematology Partners | Campbell | California |
| United States | Carolinas Hematology/Oncology | Charlotte | North Carolina |
| United States | Ingalls Memorial Hospital | Chicago | Illinois |
| United States | Rush University | Chicago | Illinois |
| United States | Case Western Reserve Univ. | Cleveland | Ohio |
| United States | Michigan State University | East Lansing | Michigan |
| United States | Cancer Care Associates | Fresno | California |
| United States | Northeast Georgia Medical Center | Gainesville | Georgia |
| United States | The Jones Clinic | Germantown | Tennessee |
| United States | Moses Cone Medical System | Greensboro | North Carolina |
| United States | Pinnacle Health | Harrisburg | Pennsylvania |
| United States | Penn. State Univ. | Hershey | Pennsylvania |
| United States | Clearview Cancer Center | Huntsville | Alabama |
| United States | Community Hospitals of Indiana | Indianapolis | Indiana |
| United States | Indiana University | Indianapolis | Indiana |
| United States | Florida Oncology Associates | Jacksonville | Florida |
| United States | Horizon Oncology Center | Lafayette | Indiana |
| United States | Prohealth Associates | Lake Success | New York |
| United States | Memorial Miller Hospital | Long Beach | California |
| United States | Central Georgia Cancer Care | Macon | Georgia |
| United States | The West Clinic | Memphis | Tennessee |
| United States | Montgomery Cancer Care | Mount Sterling | Kentucky |
| United States | Peninsula Cancer Institute | Newport News | Virginia |
| United States | Mid Illinois Hematology & Oncology | Normal | Illinois |
| United States | Northern Utah Associates | Ogden | Utah |
| United States | Mercy Physicians of Oklahoma | Oklahoma City | Oklahoma |
| United States | St. Joseph Hospital | Orange | California |
| United States | Desert Regional Comprehensive Cancer Center | Palm Springs | California |
| United States | Hematology Oncology Associates | Port St. Lucie | Florida |
| United States | Kaiser Northwest | Portland | Oregon |
| United States | Kootenai Medical Center | Post Falls | Idaho |
| United States | UC San Diego | San Diego | California |
| United States | Redwood Regional Medical Group | Santa Rosa | California |
| United States | Summit Cancer Care | Savannah | Georgia |
| United States | Medical Oncology Associates | Spokane | Washington |
| United States | Stony Brook University | Stony Brook | New York |
| United States | Northwest Medical Specialties | Tacoma | Washington |
| United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
| United States | Scott & White Healthcare | Temple | Texas |
| United States | Connecticut Oncology & Hematology | Torrington | Connecticut |
| United States | Cancer Care Associates | Tulsa | Oklahoma |
| United States | Medical Oncology Hematology | Waterbury | Connecticut |
| United States | Cancer Center of Kansas | Wichita | Kansas |
| United States | Cancer Treatment Centers of America | Zion | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Geron Corporation |
United States, Canada,
Goldblatt EM, Gentry ER, Fox MJ, Gryaznov SM, Shen C, Herbert BS. The telomerase template antagonist GRN163L alters MDA-MB-231 breast cancer cell morphology, inhibits growth, and augments the effects of paclitaxel. Mol Cancer Ther. 2009 Jul;8(7):2027-35. doi: 10.1158/1535-7163.MCT-08-1188. Epub 2009 Jun 9. — View Citation
Herbert BS, Wright WE, Shay JW. Telomerase and breast cancer. Breast Cancer Res. 2001;3(3):146-9. Epub 2001 Feb 22. Review. — View Citation
Hochreiter AE, Xiao H, Goldblatt EM, Gryaznov SM, Miller KD, Badve S, Sledge GW, Herbert BS. Telomerase template antagonist GRN163L disrupts telomere maintenance, tumor growth, and metastasis of breast cancer. Clin Cancer Res. 2006 May 15;12(10):3184-92. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival | 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. | Occurring post randomization through end of study period (9 mos. after the last participant is randomized) | No |
| Secondary | Objective response | Objective response as determined by the investigator according to RECIST for patients with measurable disease at baseline. | Occurring post randomization through end of study period (9 mos. after the last participant is randomized) | No |
| Secondary | Clinical benefit rate | Clinical response rate includes patients with objective response and stable disease lasting at least 6 months. | Occurring post randomization through end of study period (9 mos. after the last participant is randomized) | No |