Trial · NCT03281681
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimate Overall Response Rate | Every 8 weeks from Screening to achievement of either complete response (CR) or partial response (PR) for at least 6 months | Overall number of tumor complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria or GCIG criteria using computed tomography (CT) or magnetic resonance imaging (MRI) |
| Secondary | Safety evaluation of VAL-083 for adverse events | From Screening up to 28 days following last study treatment with VAL-083 | Using NCI CTCAE version 4 criteria to assess frequency, severity and study drug relationship of clinically significant changes in vital signs, lab test results, EKGs or any other adverse events reported while patients are receiving treatment with VAL-083 |
| Secondary | Efficacy evaluation of VAL-083 against CA-125 biomarker | From Screening to achievement of either complete response (CR) or partial response (PR) for at least 6 months | To measure the changes in concentration of CA-125 antigen levels in blood |
| Secondary | Progression-free Survival | Every 30 days from Screening until disease progression or patient death, whichever occurs first, for at least 6 months | Time from start of treatment until first occurrence of progression or patient death, whichever occurs first |
| Secondary | Comparative Progression-free Survival | Every 30 days from Screening until disease progression or patient death, whichever occurs first, for at least 6 months | Progression-free Survival for VAL-083 compared to Progression-free Survival for patient's last treatment regimen received |
| Secondary | Duration of Response | Every 8 weeks from Screening to achievement of either complete response (CR) or partial response (PR) for at least 6 months | Time from start of treatment to achievement of either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria or GCIG criteria using computed tomography (CT) or magnetic resonance imaging (MRI) |
| Secondary | Overall Survival | Every 30 days from Screening until patient death or for at least 6 months, whichever occurs first | Length of time from start of treatment until patient death |
| Secondary | Cmax | Treatment Day 1 pre-dose, then 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of i.v. infusion of VAL-083 | Maximum observed plasma concentration of VAL-083 in the first 10 study subjects receiving VAL-083 |
| Secondary | Tmax | Treatment Day 1 pre-dose, then 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of i.v. infusion of VAL-083 | Time of maximum observed plasma concentration of VAL-083 in the first 10 study subjects receiving VAL-083 |
| Secondary | AUClast | Treatment Day 1 pre-dose, then 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of i.v. infusion of VAL-083 | Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration of VAL-083 in plasma for the first 10 study subjects receiving VAL-083 |
| Secondary | AUCinf | Treatment Day 1 pre-dose, then 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of i.v. infusion of VAL-083 | Area under the concentration-time curve extrapolated to infinity for VAL-083 in plasma of the first 10 study subjects receiving VAL-083 |
| Secondary | Lambda z | Treatment Day 1 pre-dose, then 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of i.v. infusion of VAL-083 | Terminal elimination rate constant determined by selection of at least 3 decreasing data points on the terminal phase of the concentration-time curve for VAL-083 in plasma of the first 10 study subjects receiving VAL-083 |
| Secondary | T 1/2 | Treatment Day 1 pre-dose, then 15 ± 5 min, 30 ± 5 min, 60 ± 10 min, 120 ± 10 min, 240 ± 15 min, and 360 ± 15 min after the end of the of i.v. infusion of VAL-083 | Terminal elimination half-life of VAL-083 in plasma of the first 10 study subjects receiving VAL-083 |
| Secondary | Quality of Life | Every 4 weeks from Screening until disease progression, for at least 6 months | Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI) |
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
Read this list from software.
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