NCT01112293 · OUTCOME
Number of Participants With a Change of Serum Biomarkers After Therapy
Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural Mesothelioma · Source last updated 2020-04-10
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
- 18 months
What was measured
Evaluation of changes after treatment therapy to a number of potential blood biomarkers of TGF-β effect (serum osteopontin, serum hyaluronan, serum MMP-1, serum MMP-7, serum IL-6, plasma CCL18, plasma VEGF, and plasma PAI-1). Animal models predict acute changes in TGF-β levels in blood associated with changes in serum biomarkers.
Analysis population: Outcome analysis presented in manuscript of results of trial based on 13 participants.
Groups in this outcome
Investigational Drug infusion-for Safety and Effectiveness
Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment
GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
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 |
|---|
| Investigational Drug infusion-for Safety and Effectiveness | 13 |
|---|
Reported measurements
Change in serum osteopontin after treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Investigational Drug infusion-for Safety and Effectiveness | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Change in serum hyaluronan after treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Investigational Drug infusion-for Safety and Effectiveness | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Change in serum MMP-1 after treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Investigational Drug infusion-for Safety and Effectiveness | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Change in serum MMP-7 after treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Investigational Drug infusion-for Safety and Effectiveness | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Change in serum IL-6 V after treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Investigational Drug infusion-for Safety and Effectiveness | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Change in plasma CCL18 v after treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Investigational Drug infusion-for Safety and Effectiveness | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Change in plasma VEGF after treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Investigational Drug infusion-for Safety and Effectiveness | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Change in plasma PAI-1 after treatment
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Investigational Drug infusion-for Safety and Effectiveness | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Change in serum osteopontin after treatment
- title
- Change in serum hyaluronan after treatment
- title
- Change in serum MMP-1 after treatment
- title
- Change in serum MMP-7 after treatment
- title
- Change in serum IL-6 V after treatment
- title
- Change in plasma CCL18 v after treatment
- title
- Change in plasma VEGF after treatment
- title
- Change in plasma PAI-1 after treatment
- description
- Evaluation of changes after treatment therapy to a number of potential blood biomarkers of TGF-β effect (serum osteopontin, serum hyaluronan, serum MMP-1, serum MMP-7, serum IL-6, plasma CCL18, plasma VEGF, and plasma PAI-1). Animal models predict acute changes in TGF-β levels in blood associated with changes in serum biomarkers.
- groups
- description
- Phase II, Single-Arm, Multi-Site study. All subjects will receive the investigational agent, GC1008 in 3 week cycles of treatment
GC1008: GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
- id
- OG000
- title
- Investigational Drug infusion-for Safety and Effectiveness
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Outcome analysis presented in manuscript of results of trial based on 13 participants.
- reporting Status
- POSTED
- time Frame
- 18 months
- title
- Number of Participants With a Change of Serum Biomarkers After Therapy
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle