Trial · NCT03397706
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number (Proportion) of Participants With Adverse Events (AEs) | Up to approximately 2 years | Safety Analysis Set, defined as all enrolled patients who received at least 1 dose of study treatment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b | Cycle 1 (28 days) | Safety Analysis Set, defined as all enrolled patients who received at least 1 dose of study treatment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response Rate | Up to approximately 2 years | Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response | Up to approximately 2 years | Patients who achieved a CR or PR. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | days | MEDIAN |
| SECONDARY | Time to Response | Up to approximately 2 years | Patients who achieved a PR or CR. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | days | MEDIAN |
| SECONDARY | Progression-Free Survival | Up to approximately 2 years | Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | days | MEDIAN |
| SECONDARY | Disease Control Rate | Up to approximately 2 years | Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Up to approximately 2 years | Efficacy Evaluable Analysis Set, defined as all patients with measurable/evaluable disease at screening who met all eligibility criteria and had at least one evaluable post-baseline efficacy tumor assessment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment. | days | MEDIAN |
| SECONDARY | Cmax (ng/mL) of VRx-3996 | Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1 | The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations. | ng/mL | MEAN |
| SECONDARY | Cmax (ng/mL) of Valganciclovir | Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1 | The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations. | ng/mL | MEAN |
| SECONDARY | Area Under Curve (AUC) 0-t of VRx-3996 | Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1 | The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations. The PK Population will also be used for individual and mean figures for plasma concentrations. | h*ng/mL | MEAN |
| SECONDARY | AUC 0-t of of Valganciclovir | Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1 | The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations. | h*ng/mL | MEAN |
| SECONDARY | Half-life of VRx-3996 | Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1 | The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations. | hours | MEAN |
| SECONDARY | Half-life of Valganciclovir | Phase 1b: Cycle 1 Day 1 and Phase 2: multiple doses through Cycle 2 Day 1 | The PK Analysis Set was used for all PK analyses and included all patients in the intent-to-treat population (defined as all enrolled patients) who had at least one postdose measurable PK concentration. The PK Analysis Set will be used for individual plasma concentration listings and summaries of plasma concentrations. | hours | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT03397706/outcomes