Trial · NCT03607955
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance | Completion of the enrollment and treatment of all patients (estimated to be approximately 26 months) | * The study will employ the Bayesian optimal interval design (BOIN) to find the MTD. * Select as the MTD the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate. If there are ties, select the higher dose level when the isotonic estimate is lower than the target toxicity rate and select the lower dose level when the isotonic estimate is greater than or equal to the target toxicity rate. |
| Primary | Dose limiting toxicities (DLTs) of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance | Through completion of 1st cycle for all patients (estimated to be 13 months) | -Hematologic DLT any of the following that occur during the 1st cycle (C) that are possibly (pos), probably (prob), or definitely (def) related to the study treatment: * Grade (Gr.) 4 neutropenia or thrombocytopenia \> 7 day * Febrile neutropenia w/ temp \> 38.5 °C * Gr. 4 anemia or Gr. 4 thrombocytopenia which requires transfusion therapy on more than 2 occasions in 7 days * Gr. thrombocytopenia w/ bleeding Non-hematologic DLT is any pos, prob, or def related Gr. 3 or grade 4 non-hematologic toxicity that occurs during C1 with the following exceptions: * Gr. 3/4 nausea/vomiting/anorexia that returns to Gr. 1 prior to the start of C2 * Gr. 3 nausea/vomiting or diarrhea \< 72 hours with adequate antiemetic and other supportive care starting with C2 * Gr. 3 triglycerides will only be considered a DLT for patients who have grade 3 in spite of appropriate lipid lowering drug therapy * Gr. 3 rash (patients who have received 2 weeks of supportive care treatment w/ no improvement) |
| Primary | Tolerability of the combination at the MTD of AVB-S6-500 assessed in combination with standard neoadjuvant chemotherapy as measured by treatment discontinuation | Through completion of treatment (estimated to be 14 months) | |
| Primary | Tolerability of the combination at the MTD of AVB-S6-500 assessed in combination with standard neoadjuvant chemotherapy as measured by number of dose interruption/reductions | Through completion of treatment (estimated to be 14 months) | |
| Primary | Tolerability of the combination at the MTD of AVB-S6-500 assessed in combination with standard neoadjuvant chemotherapy as measured by use of supportive therapies | Through completion of treatment (estimated to be 14 months) | |
| Primary | Tolerability of the combination at the MTD of AVB-S6-500 assessed in combination with standard neoadjuvant chemotherapy as measured by number of hospital admissions | Through completion of treatment (estimated to be 14 months) | |
| Primary | Tolerability of the combination at the MTD of AVB-S6-500 assessed in combination with standard neoadjuvant chemotherapy as measured by number of deaths | Through completion of treatment (estimated to be 14 months) | |
| Secondary | Objective clinical response (cOR) of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance | At the time of interval debulking (approximately 9-12 weeks) | -cOR = clinical response seen at the time of surgery with no visible disease |
| Secondary | Pathological complete response (pCR) at the time of interval debulking surgery of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance | At the time of interval debulking (approximately 9-12 weeks) | -pCR = pathological response seen by the pathology at the time of surgery with treatment effect and no disease seen microscopically |
| Secondary | Progression-free survival (PFS) at 1 year after debulking surgery of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance | 1 year after debulking surgery (approximately 64 weeks) | * PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). |
| Secondary | Progression-free survival (PFS) at 2 years after debulking surgery of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance | 2 years after debulking surgery (approximately 116 weeks) | * PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. * Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). |
| Secondary | Overall survival (OS) by long-term follow-up of AVB-S6-500 in combination with and following conventional chemotherapy and maintenance | 5 years after completion of treatment (approximately 74 months) | -OS is defined as the time from the date of treatment to the date of death, censored at the last follow-up otherwise. |
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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GET https://conductscience.org/api/trials/v1/NCT03607955/registered