Trial · NCT06994572
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 monotherapy | Up to 12 months | Safety and tolerability of CT-01 will be evaluated by monitoring the incidence of TEAEs, SAEs, AESIs, and TEAEs leading to study discontinuation or death. Unit of Measure: Number, nature, sverity and relation plausibility of AE |
| Primary | Maximum tolerated dose (MTDm) of CT-01 monotherapy | Up to 12 months | The MTDm will be determined based on the incidence and type of dose-limiting toxicities (DLTs) during Cycle 1 of CT-01 monotherapy. Unit of Measure: mg/day |
| Primary | Number of participants with treatment-emergent adverse events (TEAEs) during CT-01 and everolimus combination therapy | Up to 12 months | Safety and tolerability will be assessed through monitoring of TEAEs, SAEs, AESIs, and TEAEs leading to study discontinuation or death during combination therapy. Unit of Measure: Number, nature, sverity and relation plausibility of A |
| Primary | Maximum tolerated dose (MTDc) of CT-01 in combination with everolimus | Up to 12 months | The MTDc will be determined based on the incidence of DLTs during Cycle 1 of the combination therapy. Unit of Measure: mg/day |
| Secondary | Objective response rate (ORR) per RECIST v1.1 and mRECIST for CT-01 monotherapy | Up to 12 months | Proportion of participants achieving complete or partial response as per RECIST v1.1 and mRECIST. Unit of Measure: Percentage of participants |
| Secondary | Objective response rate (ORR) per RECIST v1.1 and mRECIST for CT-01 and everolimus | Up to 12 months | Proportion of participants achieving complete or partial response during combination therapy. Unit of Measure: Percentage of participants |
| Secondary | Maximum plasma concentration (Cmax) | Up to 12 months | Cmax will be determined for CT-01 using non-compartmental analysis. Unit of Measure: ng/mL |
| Secondary | Area under the concentration-time curve (AUC) | Up to 12 months | AUC will be calculated for active metabolite of CT-01 using non-compartmental methods (AUC₀-t and AUC₀-inf). Unit of Measure: ng·h/mL |
| Secondary | Time to maximum concentration (Tmax) | Up to 12 months | Tmax will be recorded as the time to reach Cmax for CT-01. Unit of Measure: Hours |
| Secondary | Change from baseline in MELD-Na score during combination therapy | Up to 12 months | Change in MELD-Na score (range: typically 6 to 40; higher scores indicate worse liver function) from baseline during CT-01 and everolimus treatment. Unit of Measure: score |
| Secondary | Change from baseline in Child-Pugh score during combination therapy | Up to 12 months | Change in Child-Pugh score (range: 5-15; higher scores indicate worse liver function) from baseline during CT-01 and everolimus treatment. Unit of Measure: score |
| Secondary | Change from baseline in Albumin-Bilirubin (ALBI) score during combination therapy | Up to 12 months | Change from baseline in ALBI score will be evaluated during CT-01 and everolimus combination therapy. The ALBI score is calculated using serum bilirubin and albumin. Changes from baseline will be summarized by time point. Higher scores indicate worse liver function. Unit of Measure: score |
| Secondary | Change from baseline in lipid profile during combination therapy | Up to 12 months | Change in serum lipid parameters (total cholesterol, LDL, HDL, triglycerides) from baseline during CT-01 and everolimus treatment. Unit of measure: mmol/L |
| Secondary | Change from baseline in serum glucose levels during combination therapy | Up to 12 months | Change in blood glucose concentration from baseline during CT-01 and everolimus treatment. Unit of Measure: mmol/L |
| Secondary | Change from baseline in serum alpha-fetoprotein (AFP) levels during combination therapy | Up to 12 months | Change in serum AFP concentration from baseline during treatment with CT-01 in combination with everolimus. AFP is a tumor marker used in hepatocellular carcinoma. Unit of Measure: ng/mL |
| Secondary | Terminal half-life (T1/2) | Up to 12 months | T1/2 will be estimated for active metabolite of CT-01 from the log-linear terminal phase of the concentration-time curve. Unit of Measure: Hours |
| Secondary | Title: Maximum plasma concentration (Cmax) | Up to 12 months | Cmax will be determined for CT-01 in combination with everolimus using non-compartmental analysis. Unit of Measure: ng/mL |
| Secondary | Change from baseline in serum glucose levels during monotherapy | Up to 12 months | Change in blood glucose concentration from baseline during CT-01 monotherapy. Unit of Measure: mmol/L |
| Secondary | Area under the concentration-time curve (AUC) | Up to 12 months | AUC for active metabolite of CT-01 in combination with everolimus will be calculated using non-compartmental methods. ng·h/mL |
| Secondary | Time to maximum concentration (Tmax) | Up to 12 months | Tmax will be recorded for CT-01 when administered with everolimus. Unit of Measure: Hours |
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/NCT06994572/registered