Trial · NCT03107988
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MTD/RP2D Determination A1 | All toxicities from enrollment until completion of course 2 (Day 56) | Proportion of patients with course 1 DLT and/or course 2 neuropsychological DLT in cohort A1 |
| Primary | MTD/RP2D Determination A2 | All toxicities from enrollment until completion of course 2 (Day 56) | Proportion of patients with course 1 DLT and/or course 2 neuropsychological DLT in cohort A2 |
| Primary | MTD/RP2D Determination B2 | All toxicities from enrollment until completion of course 1 (Day 28) | Proportion of patients with course 1 DLT in cohort B2 |
| Primary | Describe Non-Hematological Toxicities (A1 and B1) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Proportion of patients with any grade 3 or greater non-hematological toxicities on any course in A1 and B1 |
| Primary | Describe Hematological Toxicities (A1 and B1) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Proportion of patients with any grade 3 or greater hematological toxicities on any course in A1 and B1 |
| Primary | Describe Non-Hematological Toxicities (A2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Proportion of patients with any grade 3 or greater non-hematological toxicities in A2 |
| Primary | Describe Hematological Toxicities (A2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Proportion of patients with any grade 3 or greater hematological toxicities in A2 |
| Primary | Describe Non-Hematological Toxicities (B2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Proportion of patients with any grade 3 or greater non-hematological toxicities in B2 |
| Primary | Describe Hematological Toxicities (B2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Proportion of patients with any grade 3 or greater hematological toxicities in B2 |
| Secondary | Pharmacokinetics A1 and B1-Steady State AUC | Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose) | Steady State AUC for lorlatinib in patients in cohort A1 and B1 |
| Secondary | Pharmacokinetics A2-Steady State AUC | Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose) | Steady State AUC for lorlatinib in patients in cohort A2 |
| Secondary | Pharmacokinetics B2-Steady State AUC | Day 1 through Day 15 (0, 1, 2, 24, 360, 361, 362, 364, 366 hours post-initial dose) | Steady State AUC for lorlatinib in patients in cohort B2 |
| Secondary | Overall Response A1 and B1 | From Day 1 of protocol therapy through 30 days following end of protocol therapy, an average of 10 months | Proportion of patients evaluable for response with a best overall response of CR/CR-MD/PR for patients in cohort A1 and B1 |
| Secondary | Overall Response A2 | From Day 1 of protocol therapy through 30 days following end of protocol therapy, an average of 10 months | Proportion of patients evaluable for response with a best overall response of CR/CR-MD/PR for patients in cohort A2 |
| Secondary | Overall Response B2 | From Day 1 of protocol therapy through 30 days following end of protocol therapy, an average of 10 months | Proportion of patients evaluable for response with a best overall response of CR/CR-MD/PR for patients in cohort B2 |
| Secondary | Pharmacokinetics A1 and B1-Cmax | Day 15 | Cmax for lorlatinib in patients in cohort A1 and B1 |
| Secondary | Pharmacokinetics A2-Cmax | Day 15 | Cmax for lorlatinib in patients in cohort A2 |
| Secondary | Pharmacokinetics B2-Cmax | Day 15 | Cmax for lorlatinib in patients in cohort B2 |
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/NCT03107988/registered