Trial · NCT03691207
A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
NCT03691207, Phase 2, Completed, Ayala Pharmaceuticals, Inc,; results first posted 2024-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations. Trials, record NCT03691207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03691207
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of AL101In Patients With Adenoid Cystic Carcinoma (ACC) Bearing Activating Notch Mutations
- NCT number
- NCT03691207
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 87 participants, actual
- Lead sponsor
- Ayala Pharmaceuticals, Inc,
- Conditions
- Adenoid Cystic Carcinoma
- Interventions
- AL101
- First posted
- 2018-10-01
- Last updated
- 2024-01-31
- Results first posted
- 2024-01-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | 3 years and 7 months | ORR is defined as partial response (PR) + complete response (CR) as assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for target lesions assessed by MRI. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Clinical Benefit Response Rate (CBR) | 3 years and 7 months | Clinical benefit response rate (CBR) is defined as complete response (CR) + partial response (PR) + stable disease (SD) by investigator review based on RECIST v1.1 for target lesions assessed by MRI. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage (at least 30%) to qualify for PR nor sufficient increase (more than 20%) to qualify for PD, taking as reference the smallest sum diameters. |
| Secondary | Overall Survival | 3 years and 5 months | Overall survival is defined at the time from first infusion of investigational product to death due to any cause. Subjects with no documentation of death were censored at the last known date known to be alive. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | 3 years and 7 months | Efficacy evaluable analysis set includes all subjects who receive at least one complete infusion of study drug, have measurable disease at baseline per RECIST v1.1 or modified MDA criteria for bone-exclusive disease and have at least one post-baseline on-study assessment of tumor response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit Response Rate (CBR) | 3 years and 7 months | Efficacy evaluable analysis set includes all subjects who receive at least one complete infusion of study drug, have measurable disease at baseline per RECIST v1.1 or modified MDA criteria for bone-exclusive disease and have at least one post-baseline on-study assessment of tumor response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | 3 years and 5 months | Efficacy evaluable analysis set includes all subjects who receive at least one complete infusion of study drug, have measurable disease at baseline per RECIST v1.1 or modified MDA criteria for bone-exclusive disease and have at least one post-baseline on-study assessment of tumor response. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Cohort 1 - AL101 4mg | 3 | Participants | ||
| Overall Response Rate (ORR) | Cohort 2 - AL101 6mg | 2 | Participants | ||
| Clinical Benefit Response Rate (CBR) | Cohort 1 - AL101 4mg | 28 | Participants | ||
| Clinical Benefit Response Rate (CBR) | Cohort 2 - AL101 6mg | 24 | Participants | ||
| Overall Survival | Cohort 1 - AL101 4mg | 9.3 | 95% Confidence Interval 6.6 to 14.2 | months | |
| Overall Survival | Cohort 2 - AL101 6mg | 9.4 | 95% Confidence Interval 5.9 to 11.9 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 - AL101 4mg | 45 | |
| Overall Study | STARTED | Cohort 2 - AL101 6mg | 42 | |
| Overall Study | COMPLETED | Cohort 1 - AL101 4mg | 0 | |
| Overall Study | COMPLETED | Cohort 2 - AL101 6mg | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 - AL101 4mg | 45 | |
| Overall Study | NOT COMPLETED | Cohort 2 - AL101 6mg | 42 |
Source ClinicalTrials.gov
Adverse events270
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 | Cohort 1 - AL101 4mg | 31 | 45 | |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 2 - AL101 6mg | 33 | 42 | |
| other | Nausea | Gastrointestinal disorders | Cohort 1 - AL101 4mg | 30 | 45 | |
| other | Nausea | Gastrointestinal disorders | Cohort 2 - AL101 6mg | 19 | 42 | |
| other | Vomiting | Gastrointestinal disorders | Cohort 1 - AL101 4mg | 21 | 45 | |
| other | Vomiting | Gastrointestinal disorders | Cohort 2 - AL101 6mg | 13 | 42 | |
| other | Constipation | Gastrointestinal disorders | Cohort 1 - AL101 4mg | 10 | 45 | |
| other | Constipation | Gastrointestinal disorders | Cohort 2 - AL101 6mg | 10 | 42 | |
| other | Dry mouth | Gastrointestinal disorders | Cohort 1 - AL101 4mg | 7 | 45 | |
| other | Dry mouth | Gastrointestinal disorders | Cohort 2 - AL101 6mg | 13 | 42 |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 - AL101 4mg | 41 | 45 |
| Total, all-cause mortality | Cohort 2 - AL101 6mg | 26 | 42 |
| Total, other adverse events | Cohort 1 - AL101 4mg | 45 | 45 |
| Total, other adverse events | Cohort 2 - AL101 6mg | 42 | 42 |
| Total, serious adverse events | Cohort 1 - AL101 4mg | 23 | 45 |
| Total, serious adverse events | Cohort 2 - AL101 6mg | 26 | 42 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 - AL101 4mg vs Cohort 2 - AL101 6mg: Overall Response Rate (ORR) | Trial comparisons |
| Cohort 1 - AL101 4mg vs Cohort 2 - AL101 6mg: Clinical Benefit Response Rate (CBR) | Trial comparisons |
| Cohort 1 - AL101 4mg vs Cohort 2 - AL101 6mg: deaths from any cause | Trial comparisons |
| Cohort 1 - AL101 4mg vs Cohort 2 - AL101 6mg: serious adverse events | Trial comparisons |
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/NCT03691207
GET https://conductscience.org/api/trials/v1/NCT03691207/events?page=2