Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer

Sponsor

Geron Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01256762

Collaborator

(none)

166

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Locally Recurrent or Metastatic Breast Cancer	Drug: Imetelstat sodium Drug: Bevacizumab Drug: Paclitaxel	Phase 2

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.

Study Design

Study Type:

Interventional

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 :

Nov 1, 2010

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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 Names: GRN163L Drug: Bevacizumab Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle Other Names: Avastin Drug: Paclitaxel Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle Other Names: 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 Names: Avastin Drug: Paclitaxel Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle Other Names: Taxol

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 Names:

GRN163L

Drug: Bevacizumab

Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle

Other Names:

Avastin

Drug: Paclitaxel

Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle

Other Names:

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 Names:

Avastin

Drug: Paclitaxel

Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle

Other Names:

Taxol

Outcome Measures

Primary Outcome Measures

Progression-free survival [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Clearview Cancer Center	Huntsville	Alabama	United States	35805
2	Alta Bates Summit Medical Center	Berkeley	California	United States	94704
3	Southbay Oncology Hematology Partners	Campbell	California	United States	95008
4	Cancer Care Associates	Fresno	California	United States	93720
5	Memorial Miller Hospital	Long Beach	California	United States	90806
6	St. Joseph Hospital	Orange	California	United States	92868
7	Desert Regional Comprehensive Cancer Center	Palm Springs	California	United States	92262
8	UC San Diego	San Diego	California	United States	92093
9	Redwood Regional Medical Group	Santa Rosa	California	United States	95403
10	Univ. Colorado at Denver	Aurora	Colorado	United States	80045
11	Connecticut Oncology & Hematology	Torrington	Connecticut	United States	06790
12	Medical Oncology Hematology	Waterbury	Connecticut	United States	06708
13	Florida Oncology Associates	Jacksonville	Florida	United States	32256
14	Hematology Oncology Associates	Port St. Lucie	Florida	United States	34952
15	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33612
16	Northeast Georgia Cancer Care	Athens	Georgia	United States	30607
17	Peachtree Hematology Oncology	Atlanta	Georgia	United States	30318
18	Emory University	Atlanta	Georgia	United States	30322
19	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
20	Central Georgia Cancer Care	Macon	Georgia	United States	31201
21	Summit Cancer Care	Savannah	Georgia	United States	31405
22	Kootenai Medical Center	Post Falls	Idaho	United States	83854
23	Ingalls Memorial Hospital	Chicago	Illinois	United States	60426
24	Rush University	Chicago	Illinois	United States	60612
25	Mid Illinois Hematology & Oncology	Normal	Illinois	United States	61761
26	Cancer Treatment Centers of America	Zion	Illinois	United States	60099
27	Indiana University	Indianapolis	Indiana	United States	46202
28	Community Hospitals of Indiana	Indianapolis	Indiana	United States	46268
29	Horizon Oncology Center	Lafayette	Indiana	United States	47905
30	Cancer Center of Kansas	Wichita	Kansas	United States	67214
31	Montgomery Cancer Care	Mount Sterling	Kentucky	United States	40353
32	Michigan State University	East Lansing	Michigan	United States	48823
33	New Mexico Cancer Center	Albuquerque	New Mexico	United States	87109
34	Prohealth Associates	Lake Success	New York	United States	11402
35	Stony Brook University	Stony Brook	New York	United States	11794
36	Carolinas Hematology/Oncology	Charlotte	North Carolina	United States	28203
37	Moses Cone Medical System	Greensboro	North Carolina	United States	27403
38	Case Western Reserve Univ.	Cleveland	Ohio	United States	44106
39	Mercy Physicians of Oklahoma	Oklahoma City	Oklahoma	United States	73120
40	Cancer Care Associates	Tulsa	Oklahoma	United States	74136
41	Kaiser Northwest	Portland	Oregon	United States	97232
42	Pinnacle Health	Harrisburg	Pennsylvania	United States	17110
43	Penn. State Univ.	Hershey	Pennsylvania	United States	17033
44	The Jones Clinic	Germantown	Tennessee	United States	38138
45	The West Clinic	Memphis	Tennessee	United States	38120
46	Scott & White Healthcare	Temple	Texas	United States	76508
47	Northern Utah Associates	Ogden	Utah	United States	84403
48	Peninsula Cancer Institute	Newport News	Virginia	United States	23601
49	Medical Oncology Associates	Spokane	Washington	United States	99208
50	Northwest Medical Specialties	Tacoma	Washington	United States	98405
51	Grand River Regional Cancer Centre	Kitchener	Ontario	Canada	N2G 1G3
52	Stronach Regional Cancer Centre at Southlake	Newmarket	Ontario	Canada	L3Y 2P9
53	The Ottawa Hospital Cancer Centre	Ottawa	Ontario	Canada	K1H 8L6
54	Sunnybrook Health Services Centre	Toronto	Ontario	Canada	M4N 3M5
55	McGill University	Montreal	Quebec	Canada	H2W 1S6