Trial · NCT03768505
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
NCT03768505, Phase 2, Terminated, MEI Pharma, Inc.; results first posted 2024-02-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL). Trials, record NCT03768505. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03768505
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
- NCT number
- NCT03768505
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 169 participants, actual
- Lead sponsor
- MEI Pharma, Inc.
- Conditions
- Follicular Lymphoma (FL), Non Hodgkin Lymphoma, Marginal Zone Lymphoma
- Interventions
- Zandelisib (ME-401)
- First posted
- 2018-12-07
- Last updated
- 2024-12-31
- Other registries' IDs
- eudract:2018-002896-17
- Results first posted
- 2024-02-01
- Limitations and caveats
- The study was closed prematurely for business reasons.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL | 3 years 9 months | ORR is measured as the proportion of subjects achieving the best response rating of CR or PR prior to first PD |
| Secondary | Duration of Response (DOR) | 3 years 9 months | Duration of Response will be measured as the time from documentation from CR or PR to time of disease progression |
| Secondary | Complete Response (CR) Rate | 3 years 9 months | Complete response rate will be measured by the number of subjects that achieve CR |
| Secondary | Progression-free Survival (PFS) | 3 years 9 months | Progression-free survival will be measurement of time from initiation of treatment (Day 1) until disease progression or death |
| Secondary | Overall Survival | 2 years | Overall survival will be measured as the time from initiation of treatment (Day 1) until death |
| Secondary | Overall Incidence of Treatment Emergent Adverse Events (TEAEs) | 3 years 9 months | The incidence of TEAEs is measured by the proportion of subjects with at least one TEAE. |
| Secondary | PK of ME-401 | 3 years 9 months | The PK of ME-401 will be determined by the peak plasma concentration (Cmax) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL | 3 years 9 months | A company decision was made to terminate all Zandelisib studies early due to business reasons including this Phase 2 study. Due to the study being terminated early, no data was collected to analyze ORR | ||
| SECONDARY | Duration of Response (DOR) | 3 years 9 months | A company decision was made to terminate all Zandelisib studies early due to business reasons including this Phase 2 study. Due to the study being terminated early, no data was collected to analyze DOR | ||
| SECONDARY | Complete Response (CR) Rate | 3 years 9 months | A company decision was made to terminate all Zandelisib studies early due to business reasons including this Phase 2 study. Due to the study being terminated early, no data was collected to analyze CR | ||
| SECONDARY | Progression-free Survival (PFS) | 3 years 9 months | A company decision was made to terminate all Zandelisib studies early due to business reasons including this Phase 2 study. Due to the study being terminated early, no data was collected to analyze PFS. | ||
| SECONDARY | Overall Survival | 2 years | Study was terminated early, therefore data was not available to measure OS at time of termination | ||
| SECONDARY | Overall Incidence of Treatment Emergent Adverse Events (TEAEs) | 3 years 9 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | PK of ME-401 | 3 years 9 months | A company decision was made to terminate all Zandelisib studies early due to business reasons including this Phase 2 study. Due to the study being terminated early, no data was collected to analyze PK |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Incidence of Treatment Emergent Adverse Events (TEAEs) | Zandelisib (ME-401) Open Label | 162 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zandelisib (ME-401) Open Label | 169 | |
| Overall Study | COMPLETED | Zandelisib (ME-401) Open Label | 0 | |
| Overall Study | NOT COMPLETED | Zandelisib (ME-401) Open Label | 169 |
Source ClinicalTrials.gov
Adverse events445
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 | Diarrhoea | Gastrointestinal disorders | Zandelisib (ME-401) Open Label | 66 | 169 | 66 |
| other | Nausea | Gastrointestinal disorders | Zandelisib (ME-401) Open Label | 38 | 169 | 38 |
| other | Abdominal pain | Gastrointestinal disorders | Zandelisib (ME-401) Open Label | 24 | 169 | 24 |
| other | Constipation | Gastrointestinal disorders | Zandelisib (ME-401) Open Label | 22 | 169 | 22 |
| other | Vomiting | Gastrointestinal disorders | Zandelisib (ME-401) Open Label | 11 | 169 | 11 |
| other | Dyspepsia | Gastrointestinal disorders | Zandelisib (ME-401) Open Label | 10 | 169 | 10 |
| other | Stomatitis | Gastrointestinal disorders | Zandelisib (ME-401) Open Label | 9 | 169 | 9 |
| other | Colitis | Gastrointestinal disorders | Zandelisib (ME-401) Open Label | 6 | 169 | 6 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Zandelisib (ME-401) Open Label | 7 | 169 | 7 |
| other | Abdominal pain upper | Gastrointestinal disorders | Zandelisib (ME-401) Open Label | 6 | 169 | 6 |
1 to 10 of 445Source ClinicalTrials.gov
See all 445 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zandelisib (ME-401) Open Label | 35 | 169 |
| Total, other adverse events | Zandelisib (ME-401) Open Label | 162 | 169 |
| Total, serious adverse events | Zandelisib (ME-401) Open Label | 69 | 169 |
Source ClinicalTrials.gov
Papers0
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/NCT03768505
GET https://conductscience.org/api/trials/v1/NCT03768505/events?page=2