Trial · NCT01239134
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Adverse Events | through 30 days post last dose | Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal |
| Primary | Part A: TRX518 peak concentration (Cmax) | various timepoints through 1 week post dose | Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518 |
| Primary | Part A: Time to peak concentration (Tmax) | various timepoints through 1 week post dose | Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518 |
| Primary | Part A: Area under the curve (AUC) | various timepoints through 1 week post dose | Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518 |
| Primary | Part A: Define a maximum single dose at which there are tolerable side effects and/or maximum PK/PcD parameter changes | End of Cycle 1 (Day 28) | |
| Primary | Parts B and C: Adverse Events | through 30 days post dose | Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal |
| Secondary | Part A: Evaluate the effect of TRX518 on lymphoid cell subset number and function | At baseline and at various timepoints up to 6 weeks post dose | |
| Secondary | Part A: Assess TRX518 immunogenicity | At baseline and at various timepoints up to 18 weeks post dose | |
| Secondary | Part A: Evaluate the effect of TRX518 on long-term safety measuring vital signs, tumor status, adverse events | At Months 6, 12, 18 and 24 | |
| Secondary | Parts B & C: TRX518 peak concentration (Cmax) | At each study visit from baseline up to end of treatment visit | Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518 |
| Secondary | Parts B & C: Time to peak concentration (Tmax) | At each study visit from baseline up to end of treatment visit | Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518 |
| Secondary | Parts B & C: Area under the curve (AUC) | At each study visit from baseline up to end of treatment visit | Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518 |
| Secondary | Parts B & C: Evaluate multi-dose TRX18 monotherapy for any evidence of antitumor activity (objective response rate, [ORR] progression free survival [PFS], duration of response and overall survival [OS]; RECIST v1.1 will be utilized | Every 8 weeks while on study treatment and every 12 weeks for survival until death or lost to follow up. | objective response rate \[ORR\], progression free survival \[PFS\], duration of response \[DoR\] and overall survival \[OS\]); RECIST v1.1 criteria will be utilized |
| Secondary | Parts B & C: Evaluate the effect of multi-dose TRX518 monotherapy on lymphoid cell subset number and function | At baseline and at various timepoints up to end of treatment visit | |
| Secondary | Parts B & C: Assess TRX518 immunogenicity | At baseline and at various timepoints up to end of treatment visit |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT01239134/registered