NCT02664961 · OUTCOME

TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA).

Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN) · Source last updated 2019-07-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 8 weeks

What was measured

Anti-Product Antibody (APA) concentrations will be measured using validated ELISA methods at the time points specified in the protocol. APA concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles. Number of patients with positive APA titers on study will be reported.

Groups in this outcome

TRC105 and/or Bevacizumab

All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks. TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing. Bevacizumab: Bevacizumab will be dosed every two weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
TRC105 and/or Bevacizumab	3

Reported measurements

Source class 1

Number of patients with negative APA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
TRC105 and/or Bevacizumab	1	Not reported	Not reported	Not reported	Not reported

Number of patients with positive APA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
TRC105 and/or Bevacizumab	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
title
Number of patients with negative APA
measurements
group Id
OG000
value
2
title
Number of patients with positive APA

denoms

counts
group Id
OG000
value
3
units
Participants

description

groups

description
All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks. TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing. Bevacizumab: Bevacizumab will be dosed every two weeks.
id
OG000
title
TRC105 and/or Bevacizumab

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

8 weeks

title

TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA).

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice