Trial · NCT03107988
NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)
NCT03107988, Phase 1, Completed, New Approaches to Neuroblastoma Therapy Consortium; results first posted 2025-09-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922). Trials, record NCT03107988. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03107988
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)
- NCT number
- NCT03107988
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 65 participants, actual
- Lead sponsor
- New Approaches to Neuroblastoma Therapy Consortium
- Conditions
- Neuroblastoma
- Interventions
- Lorlatinib, Cyclophosphamide, Topotecan, Filgrastim/pegfilgrastim
- First posted
- 2017-04-11
- Last updated
- 2025-09-15
- Results first posted
- 2025-09-15
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MTD/RP2D Determination A1 | All toxicities from enrollment until completion of course 2 (Day 56) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | MTD/RP2D Determination A2 | All toxicities from enrollment until completion of course 2 (Day 56) | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | MTD/RP2D Determination B2 | All toxicities from enrollment until completion of course 1 (Day 28) | Participants | COUNT_OF_PARTICIPANTS | |
| 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 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Hematological Toxicities (A1 and B1) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Non-Hematological Toxicities (A2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Hematological Toxicities (A2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Non-Hematological Toxicities (B2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Describe Hematological Toxicities (B2) | All toxicities from enrollment through 30 days following end of protocol therapy, an average of 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| 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) | No AUCtau is included for patients in Cohort B1DL5 as they do not have the sufficient samples at the necessary time points to calculate a terminal half-life so any estimation would not be reliable. | hours*ng/mL | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group77
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MTD/RP2D Determination A1 | Cohort A1 DL1 | 0 | Participants | ||
| MTD/RP2D Determination A1 | Cohort A1 DL2 | 0 | Participants | ||
| MTD/RP2D Determination A1 | Cohort A1 DL3 | 0 | Participants | ||
| MTD/RP2D Determination A1 | Cohort A1 DL4 | 0 | Participants | ||
| MTD/RP2D Determination A1 | Cohort A1 DL5 | 1 | Participants | ||
| MTD/RP2D Determination A2 | Cohort A2 DL 3A | 0 | Participants | ||
| MTD/RP2D Determination A2 | Cohort A2 DL4A | 1 | Participants | ||
| MTD/RP2D Determination A2 | Cohort A2 DL4A Expansion | 2 | Participants | ||
| MTD/RP2D Determination B2 | Cohort B2 DL4B | 0 | Participants | ||
| MTD/RP2D Determination B2 | Cohort B2 DL5B | 1 | Participants |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 results by groupParticipant flow39
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A1 DL1 | 3 | |
| Overall Study | STARTED | Cohort A1 DL2 | 3 | |
| Overall Study | STARTED | Cohort A1 DL3 | 3 | |
| Overall Study | STARTED | Cohort A1 DL4 | 10 | |
| Overall Study | STARTED | Cohort A1 DL5 | 6 | |
| Overall Study | STARTED | Cohort A2 DL 3A | 6 | |
| Overall Study | STARTED | Cohort A2 DL4A | 6 | |
| Overall Study | STARTED | Cohort A2 DL4A Expansion | 4 | |
| Overall Study | STARTED | Cohort B1 DL5 | 6 | |
| Overall Study | STARTED | Cohort B2 DL4B | 3 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 participant flowAdverse events3,341
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Cohort A1 DL1 | 1 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort A1 DL2 | 3 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort A1 DL3 | 1 | 3 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort A1 DL4 | 7 | 10 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort A1 DL5 | 3 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort A2 DL 3A | 4 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort A2 DL4A | 4 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort A2 DL4A Expansion | 2 | 4 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort B1 DL5 | 3 | 5 | |
| other | Anemia | Blood and lymphatic system disorders | Cohort B2 DL4B | 3 | 3 |
1 to 10 of 3,341Source ClinicalTrials.gov
See all 3,341 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A1 DL1 | 2 | 3 |
| Total, all-cause mortality | Cohort A1 DL2 | 3 | 3 |
| Total, all-cause mortality | Cohort A1 DL3 | 2 | 3 |
| Total, all-cause mortality | Cohort A1 DL4 | 9 | 10 |
| Total, all-cause mortality | Cohort A1 DL5 | 3 | 6 |
| Total, all-cause mortality | Cohort A2 DL 3A | 4 | 6 |
| Total, all-cause mortality | Cohort A2 DL4A | 2 | 6 |
| Total, all-cause mortality | Cohort A2 DL4A Expansion | 0 | 4 |
| Total, all-cause mortality | Cohort B1 DL5 | 3 | 5 |
| Total, all-cause mortality | Cohort B2 DL4B | 2 | 3 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03107988
GET https://conductscience.org/api/trials/v1/NCT03107988/results?page=2