Trial · NCT02594384
A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma
NCT02594384, Phase 1, Completed, IRulya Therapeutics Inc.; results first posted 2024-08-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma. Trials, record NCT02594384. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02594384
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma
- NCT number
- NCT02594384
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 62 participants, actual
- Lead sponsor
- IRulya Therapeutics Inc.
- Conditions
- Lymphoma, Non-Hodgkin; Leukemia, Chronic Lymphocytic
- Interventions
- LAM-002A, Rituximab, Atezolizumab
- First posted
- 2015-11-03
- Last updated
- 2024-08-22
- Results first posted
- 2024-08-22
- Limitations and caveats
Participants receiving LAM-002A with a regimen of 125 mg BID were accrued to both dose escalation (N=6) and then dose expansion (N=14), the results for the combined total (N=20) for this group is presented. Additionally, a MTD for the intermittent dosing regimen (3 days on and 4 days off every 7 days) was not established due to the shift of the trial to the dose expansion (monotherapy or combination therapy); the intermittent regimen was not further pursued after 3 subjects had been accrued.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determination of the Maximum Tolerated Dose (MTD) of Continuous Oral LAM-002A | 28 days | MTD was determined by testing increasing doses up to 125 mg twice a day or 75 mg three times a day orally on dose escalation cohorts with 3 to 6 participants each. In the dose escalation, the cohort sizes of 3 to 6 subjects allow evaluation of regimen safety using a standard definition of MTD (ie, the highest starting dose associated with DLT in \<33% of subjects during the first cycle of therapy) when administered continuously (daily administration) and then when administered intermittently (repeated courses of 3 days on and 4 days off). |
| Secondary | Peak Plasma Concentration (Cmax) of LAM-002A | 8 days | Evaluation of the peak plasma concentration (Cmax) of LAM-002A and its metabolites in plasma on Day 1 and Day 8. |
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A | 8 days | Evaluation of the Area under the concentration-time curve from time-zero to the time of the last quantifiable concentration (AUClast) of LAM-002ALAM-002A and its metabolites in plasma on Day 1 and Day 8. |
| Secondary | Objective Response Rate | 1 cycle (28 days) up to a maximum of 24 cycles | Anti-tumor response as assessed by investigator according to modified Hallek or Lugano Response Criteria by Disease Type and Cohort |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determination of the Maximum Tolerated Dose (MTD) of Continuous Oral LAM-002A | 28 days | Full analysis set=All subjects who receive ≥1 dose of study drug. | mg BID | NUMBER |
| SECONDARY | Peak Plasma Concentration (Cmax) of LAM-002A | 8 days | The PK population included all evaluable subjects who were dosed and had sufficient concentration-time data to estimate ≥1 of the planned PK parameters, as determined by the study pharmacokineticist. | ng/mL | MEAN |
| SECONDARY | Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A | 8 days | The PK population included all evaluable subjects who were dosed and had sufficient concentration-time data to estimate ≥1 of the planned PK parameters, as determined by the study pharmacokineticist. | h*ng/mL | MEAN |
| SECONDARY | Objective Response Rate | 1 cycle (28 days) up to a maximum of 24 cycles | Full Analysis Set: All participants who received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group137
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determination of the Maximum Tolerated Dose (MTD) of Continuous Oral LAM-002A | All Participants | 125 | mg BID | ||
| Peak Plasma Concentration (Cmax) of LAM-002A | LAM-002A Continuous Monotherapy - 50 mg BID | Apilimod - Day 1 | 117 | Standard Deviation 69.6 | ng/mL |
| Peak Plasma Concentration (Cmax) of LAM-002A | LAM-002A Continuous Monotherapy - 75 mg TID | Apilimod - Day 1 | 158 | Standard Deviation 61.6 | ng/mL |
| Peak Plasma Concentration (Cmax) of LAM-002A | LAM-002A Continuous Monotherapy - 100 mg BID | Apilimod - Day 1 | 263 | Standard Deviation 168 | ng/mL |
| Peak Plasma Concentration (Cmax) of LAM-002A | LAM-002A Continuous Monotherapy - 125 mg BID | Apilimod - Day 1 | 207 | Standard Deviation 82.4 | ng/mL |
| Peak Plasma Concentration (Cmax) of LAM-002A | LAM-002A Continuous Monotherapy - 150 mg BID | Apilimod - Day 1 | 243 | Standard Deviation 76.1 | ng/mL |
| Peak Plasma Concentration (Cmax) of LAM-002A | LAM-002A Intermittent Monotherapy - 150 mg | Apilimod - Day 1 | 280 | Standard Deviation 135 | ng/mL |
| Peak Plasma Concentration (Cmax) of LAM-002A | LAM-002A Continuous Monotherapy - 50 mg BID | Apilimod - Day 8 | 140 | Standard Deviation 95.1 | ng/mL |
| Peak Plasma Concentration (Cmax) of LAM-002A | LAM-002A Continuous Monotherapy - 75 mg TID | Apilimod - Day 8 | 339 | Standard Deviation 215 | ng/mL |
| Peak Plasma Concentration (Cmax) of LAM-002A | LAM-002A Continuous Monotherapy - 100 mg BID | Apilimod - Day 8 | 331 | Standard Deviation 273 | ng/mL |
1 to 10 of 137Source ClinicalTrials.gov
See all 137 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LAM-002A Continuous Monotherapy - 50 mg BID | 3 | |
| Overall Study | STARTED | LAM-002A Continuous Monotherapy - 100 mg BID | 8 | |
| Overall Study | STARTED | LAM-002A Continuous Monotherapy - 150 mg BID | 5 | |
| Overall Study | STARTED | LAM-002A Continuous Monotherapy - 75 mg TID | 4 | |
| Overall Study | STARTED | LAM-002A Intermittent Monotherapy - 150 mg BID | 3 | |
| Overall Study | STARTED | LAM-002A Continuous Monotherapy - 125 mg | 20 | |
| Overall Study | STARTED | LAM-002A + Rituximab | 12 | |
| Overall Study | STARTED | LAM-002A + Atezolizumab | 7 | |
| Overall Study | COMPLETED | LAM-002A Continuous Monotherapy - 50 mg BID | 0 | |
| Overall Study | COMPLETED | LAM-002A Continuous Monotherapy - 100 mg BID | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events2,088
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 | Nausea | Gastrointestinal disorders | LAM-002A Continuous Monotherapy - 50 mg BID | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | LAM-002A Continuous Monotherapy - 100 mg BID | 3 | 8 | |
| other | Nausea | Gastrointestinal disorders | LAM-002A Continuous Monotherapy - 150 mg BID | 3 | 5 | |
| other | Nausea | Gastrointestinal disorders | LAM-002A Continuous Monotherapy - 75 mg TID | 3 | 4 | |
| other | Nausea | Gastrointestinal disorders | LAM-002A Intermittent Monotherapy - 150 mg BID | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | LAM-002A Continuous Monotherapy - 125 mg BID | 9 | 20 | |
| other | Nausea | Gastrointestinal disorders | LAM-002A + Rituximab | 6 | 12 | |
| other | Nausea | Gastrointestinal disorders | LAM-002A + Atezolizumab | 6 | 7 | |
| other | Diarrhoea | Gastrointestinal disorders | LAM-002A Continuous Monotherapy - 50 mg BID | 1 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | LAM-002A Continuous Monotherapy - 100 mg BID | 0 | 8 |
1 to 10 of 2,088Source ClinicalTrials.gov
See all 2,088 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LAM-002A Continuous Monotherapy - 50 mg BID | 0 | 3 |
| Total, all-cause mortality | LAM-002A Continuous Monotherapy - 100 mg BID | 1 | 8 |
| Total, all-cause mortality | LAM-002A Continuous Monotherapy - 150 mg BID | 1 | 5 |
| Total, all-cause mortality | LAM-002A Continuous Monotherapy - 75 mg TID | 0 | 4 |
| Total, all-cause mortality | LAM-002A Intermittent Monotherapy - 150 mg BID | 0 | 3 |
| Total, all-cause mortality | LAM-002A Continuous Monotherapy - 125 mg BID | 3 | 20 |
| Total, all-cause mortality | LAM-002A + Rituximab | 0 | 12 |
| Total, all-cause mortality | LAM-002A + Atezolizumab | 3 | 7 |
| Total, other adverse events | LAM-002A Continuous Monotherapy - 50 mg BID | 3 | 3 |
| Total, other adverse events | LAM-002A Continuous Monotherapy - 100 mg BID | 8 | 8 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02594384
GET https://conductscience.org/api/trials/v1/NCT02594384/results?page=2