Trial · NCT02650401
Registered outcomes69
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 69
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | Approximately 6 months | Assessed by National Cancer Institute Common Terminology for Adverse Events Criteria (NCI CTCAE v4.03) |
| Primary | Recommended Phase 2 Dose (RP2D) of F1 Formulation In Pediatric Participants Able To Swallow Intact Capsules | Approximately 6 months | Assessed by NCI CTCAE v4.03 |
| Primary | Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric Participants Able To Swallow Intact Capsules | Approximately 6 months | Assessed by NCI CTCAE v4.03 |
| Primary | Recommended Phase 2 Dose (RP2D) of F06 Formulation In Pediatric In Participants Dosed Via Feeding Tube (Nasogastric Tube Or Gastric Tube) | Approximately 6 months | Assessed by NCI CTCAE v4.03 |
| Primary | Recommended Phase 2 Dose (RP2D) Of Minitablets/F15 Formulation In Pediatric Participants Unable To Swallow Intact Capsules | Approximately 6 months | Assessed by NCI CTCAE v4.03 |
| Primary | Cohort B: Objective Response Rate (ORR) | Approximately 6 months | Assessed by RANO per the BICR |
| Primary | Cohort D: ORR | Approximately 6 months | Assessed by RECIST v1.1 per the BICR |
| Secondary | Safety and Tolerability - AE, ECG and Labs assessed by NCI CTCAE v4.03 | Approximately 24 months | AE, ECG and Labs assessed by NCI CTCAE v4.03 |
| Secondary | Maximum observed plasma drug concentration (Cmax) using F1 Formulation | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | Maximum observed plasma drug concentration (Cmax) using F06 Formulation given intact | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | Maximum observed plasma drug concentration (Cmax) using F06 Formulation administered via feeding tube | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | Maximum observed plasma drug concentration (Cmax) using minitablets/F15 | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | Time to Cmax, by inspection (Tmax) using F1 Formulation | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | Time to Cmax, by inspection (Tmax) using F06 Formulation given intact | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | Time to Cmax, by inspection (Tmax) using F06 Formulation administered via feeding tube | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | Time to Cmax, by inspection (Tmax) using minitablets/F15 | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | AUC at steady state (AUCss) using F1 Formulation | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | AUC at steady state (AUCss) using F06 Formulation given intact | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | AUC at steady state (AUCss) using F06 Formulation administered via feeding tube | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
| Secondary | AUC at steady state (AUCss) using minitablets/F15 | Approximately 24 months | Assessed by plasma concentrations obtained on Days 1, 2, 8, 15, 22 (Cycle 1), Days 1, 2 (Cycle 2) and on Day 1 of every cycle thereafter |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02650401/registered