Enchant: An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer

Sponsor

Synta Pharmaceuticals Corp. (Industry)

Overall Status

Completed

CT.gov ID

NCT01677455

Collaborator

(none)

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 determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer HER-2 Positive Breast Cancer Triple Negative Breast Cancer ER/Progressive Response (PR) + Refractory to Prior Hormonal Treatment	Drug: ganetespib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HER2+ breast cancer	Drug: ganetespib Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
Experimental: Triple negative breast cancer Closed to enrollment	Drug: ganetespib Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
Experimental: ER/PR+ Refractory to Prior Hormonal Treatment	Drug: ganetespib Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.

Arm

Intervention/Treatment

Experimental: HER2+ breast cancer

Drug: ganetespib

Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.

Experimental: Triple negative breast cancer

Closed to enrollment

Drug: ganetespib

Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.

Experimental: ER/PR+ Refractory to Prior Hormonal Treatment

Drug: ganetespib

Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.

Outcome Measures

Primary Outcome Measures

Objective response rate [Week 12]
Objective response rate is based on RECIST criteria

Secondary Outcome Measures

Duration of response and progression free survival [Every six weeks until progression]
Progressive disease based on RECIST criteria. CT scans at week 6, week 12 and every 6 weeks thereafter for the duration of the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pathologically confirmed diagnosis of invasive breast cancer.
Stage IV disease.
Documented HER2 and hormonal receptor status per protocol, ER/PR+ patients must be refractory to at least one prior hormonal treatment.
ECOG Performance status 0-1.
Measurable disease per RECIST (1.1).
Adequate hematological function per protocol.
Adequate hepatic function per protocol.
Adequate renal function per protocol.
Negative serum pregnancy test at study entry for patients of childbearing potential.
Ability to understand and sign written consent and to comply with the study protocol.

Exclusion Criteria:

Presence of active or untreated CNS metastases as determined by MRI/CT scan performed during screening.
Active malignancies other than MBC within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin.
Bone as the only site of metastatic disease from breast cancer.
Prior radiotherapy to the only area of measurable disease. NOTE: Radiotherapy to a limited area other than the sole site of measurable disease is allowed, if received prior to initiation of ganetespib treatment. Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of ganetespib.
Pregnancy or lactation.
Known serious cardiac illness.
Uncontrolled intercurrent illness per protocol.
Other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Synta Pharmaceuticals Investigative Site	Birmingham	Alabama	United States	35249
2	Synta Pharmaceuticals Investigative Site	Altanta	Georgia	United States	30341
3	Synta Pharmaceuticals Investigative Site	Boston	Massachusetts	United States	02111
4	Synta Pharmaceuticals Investigative Site	New York	New York	United States	10065
5	Synta Pharmaceuticals Investigative Site	Durham	North Carolina	United States	27710
6	Synta Pharmaceuticals Investigative Site	Columbus	Ohio	United States	43210
7	Synta Pharmaceuticals Investigative Site	Philadelphia	Pennsylvania	United States	19111-2497
8	Synta Pharmaceutical Investigative Site	Houston	Texas	United States	77030
9	Synta Pharmaceuticals Investigative Site	Cordoba		Argentina
10	Synta Pharmaceuticals Investigative Site	Rosario Santa Fe		Argentina	S2000KZE
11	Synta Pharmaceuticals Investigative Site	Brussels		Belgium	B-1000
12	Synta Pharmaceutical Investigative Site	Charleroi		Belgium	6000
13	Synta Pharmaceuticals Investigative Site	Wilrijk		Belgium	2610
14	Synta Pharmaceuticals Investigative Site	Sao Paulo		Brazil	01246
15	Synta Pharmaceutical Investigative Site	Seoul	Gangnam-GU	Korea, Republic of
16	Synta Pharmaceuticals Investigative Site	Seoul	Jongno-Gu	Korea, Republic of
17	Synta Pharmacuetical Investigative Site	Seoul	Seodaemun-GU	Korea, Republic of
18	Synta Pharmaceuticals Investigative Site	Seoul	Songpa-Gu	Korea, Republic of
19	Synta Pharmaceuticals Investigative Site	Lima		Peru
20	Synta Pharmaceuticals Investigative Site	Barcelona		Spain	08035
21	Synta Pharmaceutical Investigative Site	Edinburgh		United Kingdom	EH4 2XU
22	Synta Pharmaceutical Investigative Site	Glasgow		United Kingdom	G12 0YN
23	Synta Pharmaceutical Investigative Site	Nottingham		United Kingdom	NG51PB
24	Synta Pharmaceuticals Investigative Site	Oxford		United Kingdom	OX3 9DU
25	Synta Pharmaceutical Investigative Site	Peterborough		United Kingdom	PE3 9GZ