GALAXY: Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer

• Sponsor: Synta Pharmaceuticals Corp. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01348126
• Collaborator: (none)
• Enrollment: 385
• Locations: 53
• Arms: 2
• Duration (Months): 53
• Patients Per Site: 7.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of subjects with advanced non-small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer Stage IIIB; Non-small Cell Lung Cancer Stage IV; Non-small Cell Lung Cancer Metastatic	Drug: Docetaxel; Drug: Combination of ganetespib and docetaxel	Phase 2/Phase 3

Detailed Description

Preliminary signals of clinical activity of ganetespib as a single agent have been observed in NSCLC. A novel approach to treatment of NSCLC is the combination of Hsp90 inhibitors, such as ganetespib, and taxanes. Such combinations have shown potential for synergy in preclinical and clinical evaluations with other Hsp90 inhibitors. Preclinical studies with ganetespib and taxanes have indicated that the combination of these drugs was more effective than either drug alone at inducing cell death, and an ongoing phase 1 study indicates that the combination is well tolerated and warrants systematic evaluation in a larger study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 385 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Phase IIB/III Study of Ganetespib (STA-9090) in Combination With Docetaxel Versus Docetaxel Alone in Subjects With Stage IIIb or IV Non-Small-Cell Lung Cancer
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single agent docetaxel	Drug: Docetaxel; 75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion
Experimental: Combination of ganetespib and docetaxel	Drug: Combination of ganetespib and docetaxel; Ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2. On Day 1 of each 3-week treatment cycle, ganetespib and docetaxel will be administered as separate 1-hour intravenous infusions. Ganetespib 150 mg/m2 will be administered again on Day 15 of each cycle.

Outcome Measures

Primary Outcome Measures

1. Progression-free survival in two co-primary populations [14 months]

Secondary Outcome Measures

1. Overall Response Rate [14 months]

   ORR is the proportion of subjects who achieve tumor response

2. Determine qualitative and quantitative toxicities [14 months]

   AEs will be graded by NCI-CTC criteria. Tabulations of adverse events by frequency, relatedness and severity will be presented. Data will be presented by treatment arm and overall. No formal statistical analyses are planned.

3. Determine plasma drug concentrations of the combination [14 months]

   Assessed via measurement of Cmax levels.

4. Evaluate Quality of Life [14 months]

   As measured by the EORTC QLQ -C30 questionnaire

5. Disease Control Rate [14 months]

   Disease Control Rate is defined as the proportion of patients with best response, according to modified RECIST 1.1, of CR, PR or SD, where the SD must be for at least 6 weeks or 12 weeks.

6. Tumor size change [14 months]

   Tumor size changes from baseline to at least 6 and 12 weeks

7. Overall survival [21 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• confirmed diagnosis of NSCLC

• Stage IIIB or IV NSCLC

• ECOG Performance Status 0 or 1

• Prior therapy defined as 1 prior systemic therapy for advanced disease

• measurable disease

• Radiologic evidence of disease progression following most recent prior treatment.

• Adequate hematologic, hepatic, renal function

Exclusion Criteria:

• Active or untreated CNS metastases

• Active malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin

• Serious cardiac illness or medical conditions

• Pregnant or lactating women

• Uncontrolled intercurrent illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Synta Pharmaceuticals Investigative Site	Tucson	Arizona	United States	85715
2	Synta Pharmaceuticals Investigative Site	Santa Monica	California	United States	90404
3	Synta Pharmaceuticals Investigative Site	Atlanta	Georgia	United States	30322
4	Synta Pharmaceuticals Investigative Site	Chicago	Illinois	United States	60637
5	Synta Pharmaceutials Investigative Site	Boston	Massachusetts	United States	02215
6	Synta Pharmaceuticals Investigative Site	Winston-Salem	North Carolina	United States	27103
7	Synta Pharmaceuticals Investigative Site	Kettering	Ohio	United States	45429
8	Synta Pharmaceuticals Investigative Site	Portland	Oregon	United States	97227
9	Synta Pharmaceuticals Investigative Site	Brussels		Belgium	1200
10	Synta Pharmaceuticals Investigative Site	Jette		Belgium	1090
11	Synta Pharmaceuticals Investigative Site	Yvoir		Belgium	5530
12	Synta Pharmaceuticals Investigative Site	Banja Luka		Bosnia and Herzegovina	78000
13	Synta Pharmaceuticals Investigative Site	Mostar		Bosnia and Herzegovina	88000
14	Synta Pharmaceuticals Investgative Site	Sarajevo		Bosnia and Herzegovina	71000
15	Synta Pharmaceuticals Investigative Site	Sarajevo		Bosnia and Herzegovina	71000
16	Synta Pharmaceuticals Investigative Site	Tuzla		Bosnia and Herzegovina	75000
17	Synta Pharmaceuticals Investigative Site	Hamilton		Canada	L8V 5C2
18	Synta Pharmaceuticals Investigative Site	Montreal		Canada	H3A 1A1
19	Synta Pharmaceuticals Investigative Site	Montreal		Canada	H3G 1A4
20	Synta Pharmaceuticals Investigative Site	Ottawa		Canada	K1H 8L6
21	Synta Pharmaceuticals Investigative Site	Pula		Croatia	52100
22	Synta Pharmaceuticals Investigative Site	Split		Croatia	21000
23	Synta Pharmaceuticals Investigative Site	Zagreb		Croatia	10000
24	Synta Pharmaceuticals Investigative Site	Prague		Czech Republic	180 00
25	Synta Pharmaceuticals Investigative Site	Halle		Germany	06120
26	Synta Pharmaceuticals Investigative Site	Hamburg		Germany	22045
27	Synta Pharmaceuticals Investigative Site	Mainz		Germany	55131
28	Synta Pharmaceuticals Investigative Site	Mannheim		Germany	68167
29	Synta Pharmaceuticals Investigative Site	Offenbach		Germany	63069
30	Synta Pharmaceuticals Investigative Site	Krakow		Poland	31-115
31	Synta Pharmaceuticals Investigative Site	Olsztyn		Poland	10-357
32	Synta Pharmaceuticals Investigative Site	Prabuty		Poland	82-550
33	Synta Pharmaceuticals Investigative Site	Szczecin		Poland	70-891
34	Synta Pharmaceuticals Investigative Site	Cluj - Napoca		Romania	400015
35	Synta Pharmaceuticals Investigative Site	Cluj - Napoca		Romania	400058
36	Synta Pharmaceuticals Investigative Site	Craiova		Romania	200385
37	Synta Pharmaceuticals Investigative Site	Suceava		Romania	720237
38	Synta Pharmaceuticals Investigative Site	Kazan		Russian Federation	420029
39	Synta Pharmaceuticals Investigative Site	Moscow		Russian Federation	105229
40	Synta Pharmaceuticals Investigative Site	Moscow		Russian Federation	115478
41	Synta Pharmaceuticals Investigative Site	Saint-Petersburg		Russian Federation	194075
42	Synta Pharmaceuticals Investigative Site	Saint-Petersburg		Russian Federation	197758
43	Synta Pharmaceuticals Investigative Site	Sochi		Russian Federation	354057
44	Synta Pharmaceuticals Investigative Site	Voronezh		Russian Federation	394000
45	Synta Pharmaceuticals Investigative Site	Belgrade		Serbia	11000
46	Synta Pharmaceuticals Investigative Site	Sremska Kamenica		Serbia	21204
47	Synta Pharmaceuticals Investigative Site	Badalona		Spain	08916
48	Synta Pharmaceuticals Investigative Site	Barcelona		Spain	08035
49	Synta Pharmaceuticals Investigative Site	Madrid		Spain	28040
50	Synta Pharmaceuticals Investigational Site	Leicester		United Kingdom	LE2 7HL
51	Synta Pharmaceuticals Investigative Site	London		United Kingdom	SE1 9RT
52	Synta Pharmaceuticals Investigational Site	London		United Kingdom	SW3 6JJ
53	Synta Pharmaceuticals Investigational Site	Sutton		United Kingdom	SM2 5PT

Sponsors and Collaborators

• Synta Pharmaceuticals Corp.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Synta Pharmaceuticals Corp.
• ClinicalTrials.gov Identifier: NCT01348126
• Other Study ID Numbers: 9090-08
• First Posted: May 5, 2011
• Last Update Posted: Nov 5, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Synta Pharmaceuticals Corp.: Advanced non-small cell lung cancer; NSCLC; Lung cancer
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Docetaxel

Study Results

No Results Posted as of Nov 5, 2015