Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:14 PM
NCT ID:
NCT01609556
Pre Assignment Details:
Dose expansion Cohort 4 was planned to enroll relapsed/refractory non-small cell lung cancer (NSCLC) adenocarcinoma or bronchoalveolar carcinoma (BAC) but no participants were enrolled due to a company decision to focus on endometrial and ovarian carcinoma for the initial investigation.
Recruitment Details:
A total of 206 participants were enrolled in this study, of whom 69 participants (44 to receive Schedule A and 25 to receive Schedule B treatment) were entered in dose-escalation phase and 137 participants (113 with epithelial ovarian cancer \[EOC\] and 24 with endometrial cancer \[EC\]) were entered in dose-expansion phase. Doses calculated initially based on participant's total body weight (TBW); then from protocol amendment 5 onwards, calculated based on adjusted ideal body weight (AIBW).
Study:
NCT01609556
Study Brief:
Results Section:
NCT01609556