Elesclomol (STA-4783) With Paclitaxel Versus Paclitaxel Alone in Melanoma

Sponsor

Synta Pharmaceuticals Corp. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00522834

Collaborator

(none)

630

Enrollment

101

Locations

Arms

Duration (Months)

6.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

"Elesclomol (STA-4783), N-malonyl-bis (N'-methyl-N'-thiobenzoylhydrazide) is a new chemical entity with a novel structure. STA-4783 induces an oxidative stress response in cells. This response is characterized by increased production of gene families that protect against different cellular stresses, including excessive heat, the presence of reactive oxygen species such as oxygen radicals, or the presence of heavy metals.

Subjects will participate in up to 2 weeks of screening during which time they will complete all screening procedures. Eligible subjects who have not received any prior cytotoxic chemotherapeutic agent for melanoma will be randomized in a 1:1 ratio to receive either STA-4783 213 mg/m2 in combination with paclitaxel 80 mg/m2 or paclitaxel 80 mg/m2 alone.

One treatment cycle will consist of weekly treatments for 3 weeks, followed by a 1-week rest period. Cycles will be repeated every 4 weeks until disease progression. Tumor assessments will be performed every 8 weeks from the date of randomization or sooner if the Investigator suspects progression has occurred based on clinical signs and symptoms. "

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: Elesclomol (STA-4783) Drug: Paclitaxel	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

630 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Phase 3 Trial of Elesclomol (STA-4783) in Combination With Paclitaxel Versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects With Stage IV Metastatic Melanoma (SYMMETRY)

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Elesclomol (STA-4783) in Combination With Paclitaxel	Drug: Elesclomol (STA-4783) 213 mg/m2 Elesclomol (STA-4783) plus 80 mg/m2 paclitaxel administered intravenously once a week for the first 3 weeks of a 4 week cycle. Number of cycles: Until progression or unacceptable toxicity develops
Other: 2 Paclitaxel alone	Drug: Paclitaxel 80 mg/m2 paclitaxel alone administered intravenously once a week for the first 3 weeks of a 4 weeks cycle. Number of cycles: Until progression or unacceptable toxicity develops

Arm

Intervention/Treatment

Active Comparator: 1

Elesclomol (STA-4783) in Combination With Paclitaxel

Drug: Elesclomol (STA-4783)

213 mg/m2 Elesclomol (STA-4783) plus 80 mg/m2 paclitaxel administered intravenously once a week for the first 3 weeks of a 4 week cycle. Number of cycles: Until progression or unacceptable toxicity develops

Other: 2

Paclitaxel alone

Drug: Paclitaxel

80 mg/m2 paclitaxel alone administered intravenously once a week for the first 3 weeks of a 4 weeks cycle. Number of cycles: Until progression or unacceptable toxicity develops

Outcome Measures

Primary Outcome Measures

Progression free survival [June 2009]

Secondary Outcome Measures

Overall Survival [December 2009]
Objective response rate [December 2009]
Clinical benefit rate [December 2009]
Duration of objective response [December 2009]
Safety [December 2009]
Pharmacokinetics [December 2009]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed metastatic (Stage IV) melanoma of cutaneous origin
ECOG performance status of <=2
Measurable disease according to modified RECIST
Life expectancy of greater than 12 weeks
LDH <= 2.0 x ULN
Clinical lab values within protocol parameters.
At least 18 years old and able and willing to provide informed consent to participate

Exclusion Criteria:

Previous cytotoxic chemotherapy treatment for melanoma
Received more than one regimen of immunotherapy, kinase inhibitor, biologic therapy, vaccine or investigational non-chemotherapeutic treatment for melanoma.
Presence of brain metastases
Presence or history (<= 5 years) of a second malignancy other than nonmelanoma skin cancer or cervical carcinoma in situ
Female subjects who are pregnant or nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Cancer Center	Tucson	Arizona	United States	85724
2	Winthrop P. Rockefeller Cancer Institute	Little Rock	Arkansas	United States	72205
3	University of California San Diego Moores UCSD Cancer Center	La Jolla	California	United States	92093
4	University of California, San Diego	La Jolla	California	United States	92093
5	The Angeles Clinic & Research Institute	Los Angeles	California	United States	90025
6	Jonsson Comprehensive Cancer Center Univ. of California Los Angeles	Los Angeles	California	United States	90095
7	Pacific Medical Center Research Institute	San Francisco	California	United States	94115
8	Redwood Regional Medical Group	Santa Rosa	California	United States	94503
9	Anschutz Cancer Pavillion University of Colorado	Aurora	Colorado	United States	80010
10	Hematology Oncology, P.C.	Stamford	Connecticut	United States	06902
11	Bay Pines VA Healthcare System	Bay Pines	Florida	United States
12	Univ. of Miami Hospital and Clinics	Miami	Florida	United States	33136
13	MD Anderson Cancer Center	Orlando	Florida	United States	32806
14	Piedmont Hospital	Atlanta	Georgia	United States	30309
15	Emory University Winship Cancer Institute	Atlanta	Georgia	United States	30322
16	Rush University Hospital	Chicago	Illinois	United States
17	Evanston Northwestern Healthcare	Evanston	Illinois	United States	60201
18	Joliet Oncology/Hematology Associates, LTD	Joliet	Illinois	United States	60435
19	Oncology Specialists, S.C.	Niles	Illinois	United States	60714
20	Oncology Specialists, SC	Park Ridge	Illinois	United States	60068
21	Goshen Center for Cancer Care	Goshen	Indiana	United States	46526
22	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
23	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana	United States	70809
24	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
25	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
26	Karmanos Cancer Institute, Wayne State University	Detroit	Michigan	United States
27	Hubert H. Humphrey Cancer Center	Robbinsdale	Minnesota	United States	55422
28	Ellis Fischels Cancer Center	Columbia	Missouri	United States
29	Southeast Nebraska Hematology/Oncology	Lincoln	Nebraska	United States	68510
30	Nebraska Methodist Cancer Center	Omaha	Nebraska	United States
31	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
32	Atlantic Health Research - Mountainside Hospital	Montclair	New Jersey	United States	07042
33	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-0001
34	Monter Cancer Center North Shore Hospital	Lake Success	New York	United States
35	Weill Medical College of Cornell University - Division of Hematology and Medical Oncology	New York	New York	United States	10021
36	NYU Clinical Cancer Center	New York	New York	United States
37	Stony Brook University Medical Center- Cancer Center	Stony Brook	New York	United States	11794-9446
38	UNC School of Medicine - Division of Hematology/Oncology	Chapel Hill	North Carolina	United States	27599
39	Carolina Hematology & Oncology Associates	Charlotte	North Carolina	United States	28203
40	Duke University Medical Center	Durham	North Carolina	United States	27710
41	Leo W. Jenkins Cancer Center	Greenville	North Carolina	United States	27834
42	Brody School of Medicine at East Carolina State University	Greenville	North Carolina	United States	27858
43	Derrick L. Davis Regional Cancer Center	Winston-Salem	North Carolina	United States	27103
44	The Christ Hospital	Cincinnati	Ohio	United States	45219
45	The Ohio State University.	Columbus	Ohio	United States	43210
46	Mark H. Zangmeister Cancer Center	Columbus	Ohio	United States	43219
47	Providence Cancer Center Clinical Trials	Portland	Oregon	United States	97213
48	St. Luke's Cancer Center	Bethlehem	Pennsylvania	United States	18015
49	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
50	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
51	Cancer Pavilion	Pittsburgh	Pennsylvania	United States	15323
52	Cancer Center of the Carolinas	Greenville	South Carolina	United States
53	Vanderbilt Medical Center	Nashville	Tennessee	United States	27232-6868
54	Texas Oncology, PA	Dallas	Texas	United States	75246
55	San Antonio Cancer Institute	San Antonio	Texas	United States	78229
56	Virginia Oncology Associates	Chesapeake	Virginia	United States	23320
57	Virginia Oncology Associates	Newport News	Virginia	United States	23606
58	Virginia Oncology Associates	Norfolk	Virginia	United States	23502
59	Virginia Cancer Institute	Richmond	Virginia	United States	23230
60	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109-1023
61	Marshfield Clinic	Marshfield	Wisconsin	United States	54449
62	Lismore Base Hospital, Cancer Care & Haematology Unit	Lismore	New South Wales	Australia
63	Newcastle Melanoma Unit - Calvary Mater Newcastle	Waratah	New South Wales	Australia	2298
64	Southern Medical Day Care Centre	Wollongong	New South Wales	Australia	2500
65	Redcliffe Hospital	Redcliffe	Queensland	Australia	4020
66	Princess Alexandra Hospital	Wooloongabba	Queensland	Australia	4102
67	Royal Hobart Hospital	Hobart	Tasmania	Australia
68	Fremantle Hospital	Fremantle	Western Australia	Australia	6160
69	Royal Adelaide Cancer Centre Medical Oncology	Adelaide		Australia	SA 5000
70	Patricia Ritchie Centre for Cancer Care and Research, Mater Hospital	North Sydney		Australia
71	The Tweed Hospital	Tweed Heads		Australia
72	Department of Medical Oncology, Westmead Hospital	Westmead		Australia
73	Tom Baker Cancer Centre	Calgary	Alberta	Canada
74	QE II Health Sciences Center	Halifax	Nova Scotia	Canada
75	Northeastern Ontario Regional Cancer Centre	Sudbury	Ontario	Canada
76	Cross Cancer Institute	Edmonton		Canada	AB T6G 1Z2
77	Princess Margaret Hospital	Toranto		Canada
78	Vivantes Klinikum Im Friedrichshain	Berlin		Germany
79	Vivantes Klinikum Neukölln	Berlin		Germany
80	Elbe-Klinikum Buxtehude	Buxtehude		Germany
81	University Frankfurt	Frankfurt/Main		Germany
82	University of Kiel	Kiel		Germany
83	Universität zu Köln	Köln		Germany
84	Universitätsklinikum Leipzig	Leipzig		Germany
85	Universitätsklinikum Mannheim	Mannheim		Germany
86	Universitätsklinikum Münster	Münster		Germany
87	Universitätsklinikum Würzburg	Würzburg		Germany
88	VA Medical Center	San Juan		Puerto Rico	00927
89	County Hospital Brasov - Oncology Department	Brasov		Romania	500 117
90	Oncology Institute "Prof. Dr. Ion Chiricuta"	Cluj Napoca		Romania	400 015
91	Clinical County Hospital " Alexandru Simionescu" Hunedoara	Hunedoara		Romania	331 057
92	Center of Medical Oncology	Iasi		Romania	700 106
93	Clinical County Hospital Sibiu	Sibiu		Romania	550 245
94	Oncology- Chemotherapy Clinic - Emergency Municipal Clinical Hospital	Timisoara		Romania	300 223
95	Hospital Universitario Central de Asturias	Oviedo	Asturias	Spain	33006
96	Hospital Universitario de la Princessa Servicio de Oncología Médica	Madrid		Spain	28006
97	Clinica Universitaria de Navarra	Pamplona		Spain	31008
98	Hospital Virgen de la Salud - Servicio de Oncología Médica Ciclos	Toledo		Spain
99	Oncology Centre Addenbrookes's Hospital	Cambridge		United Kingdom	CB2 0QQ
100	Northern Centre for Cancer Treatment Newcastle General Hospital	Newcastle upon Tyne		United Kingdom	NE4 6BE
101	Dorset Cancer Centre Poole Hospital NHS Foundation Trust	Poole		United Kingdom	BH15 2JB