The objective of this study is to follow up with females exposed to eleclazine in prior clinical trials.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The endpoints of interest include the number of females enrolled and the number
of females with signs or symptoms potentially consistent with uterine cancer
after eleclazine exposure.
Secondary outcome
none
Background summary
In 2016, Gilead Sciences, Inc. (Gilead) discontinued the development of
Eleclazine because Eleclazine failed to meet the primary endpoint (due to lack
of efficacy) in Study GS-US-356-0101.
Gilead Sciences issued safety notification letter in December 2017 regarding
findings from the eleclazine nonclinical 2-year rat carcinogenicity study
TX-279-2032.
These findings were shared with health authorities and Eleclazine investigators
in December 2017 via a 15 day Safety Notification Letter. During 2018 feedback
from FDA suggested a patient notification and follow-up of all subjects, BfArM
suggested follow-up of females.
Gilead have designed a Follow up Study GS-US 356-5413 for Females who received
at least one dose of Eleclazine in a prior Eleclazine clinical trial. This
Follow up Study (GS-US-356-5413) is a multi-center Study which will be
conducted in up to 11 countries, at approximately 57 sites that enrolled female
subjects in prior Eleclazine clinical trials.
Study objective
The objective of this study is to follow up with females exposed to eleclazine
in prior clinical trials.
Study design
This is a multi-center study. Sites that enrolled female subjects in prior
eleclazine clinical trials will be requested to participate in the study.
Study burden and risks
No experimental treatment will be administered in this study. The intervention
is limited to a study visit/video call with the investigator and referral for a
gynaecological evaluation. The possible risks of taking part in this study are
associated only with these visits and gynaecological examination procedures.
333 Lakeside Drive 333
Foster City CA 94404
US
333 Lakeside Drive 333
Foster City CA 94404
US
Listed location countries
Age
Inclusion criteria
1. Females who received at least one dose of eleclazine in a prior clinical
trial
2. Signed informed consent form (ICF), by the subject or a legally authorized
representative,
obtained before any study-related activities are undertaken
Exclusion criteria
none
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003958-86-NL |
| CCMO | NL81118.100.22 |