Trial · NCT05221320
Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies
NCT05221320, Phase 2, Terminated, BioMed Valley Discoveries, Inc; results first posted 2025-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies. Trials, record NCT05221320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05221320
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies
- NCT number
- NCT05221320
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- BioMed Valley Discoveries, Inc
- Conditions
- Tumor, Solid, Gastrointestinal Cancer
- Interventions
- Ulixertinib, Hydroxychloroquine
- First posted
- 2022-02-02
- Last updated
- 2025-09-25
- Results first posted
- 2025-09-25
- Limitations and caveats
Baskets 2 and 3 did not proceed past stage 1 due to futility. No definite conclusions can be drawn from baskets 1, 4 and 5 due to slow enrollment and early closure of the study.~Early termination leading to small numbers of patients analyzed.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator. | from cycle 1 day 1 until safety follow-up visit (up to 24 months) | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate. |
| Primary | The Incidence and Frequency of Serious Adverse Events (SAEs) Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment. | Baseline until safety follow-up visit (up to 24 months) | Reporting of any SAEs, all SAEs were collected/assessed at each study visit. |
| Primary | The Incidence and Frequency of Adverse Events (AEs), Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment. | Baseline until safety follow-up visit (up to 24 months) | Reporting of any AEs, all AEs were collected/assessed at each study visit. |
| Secondary | Progression-free Survival (PFS) as Defined as the Time From Study Drug Initiation to the Time of Documented Disease Progression (as Assessed by RECIST 1.1) or Death From Any Cause. | 18 months | To assess the duration of efficacy of ulixertinib and hydroxychloroquine in patients with advanced, RAS, non-V600 BRAF, ERK, or MEK mutated gastrointestinal malignancies. |
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 | Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator. | from cycle 1 day 1 until safety follow-up visit (up to 24 months) | Outcomes for stage 1 are presented for the total of 47 participants and not broken down by individual basket. None of the patients in Stage 1 met the CR or PR criteria. Stage 2 was never started due to termination of study in Stage 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Incidence and Frequency of Serious Adverse Events (SAEs) Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment. | Baseline until safety follow-up visit (up to 24 months) | Stage 2 is zero because study was terminated in stage 1. | Participants | NUMBER |
| PRIMARY | The Incidence and Frequency of Adverse Events (AEs), Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment. | Baseline until safety follow-up visit (up to 24 months) | Stage 2 was never started. | Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) as Defined as the Time From Study Drug Initiation to the Time of Documented Disease Progression (as Assessed by RECIST 1.1) or Death From Any Cause. | 18 months | Stage 2 is zero because study was terminated in stage 1. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator. | Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma | 0 | Participants | ||
Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator. | Basket 2 - Pancreatic Adenocarcinoma | 0 | Participants | ||
Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator. | Basket 3 - Colorectal Adenocarcinoma | 0 | Participants | ||
Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator. | Basket 4 - Esophageal Adenocarcinoma, Esophageal Squamous, Gastroesophageal Junction | 0 | Participants | ||
Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator. | Basket 5 - Gastric Adenocarcinoma | 0 | Participants | ||
Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator. | Stage 2 - Basket Expansion Based on Stage 1 | 0 | Participants | ||
| The Incidence and Frequency of Serious Adverse Events (SAEs) Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment. | Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma | 3 | Participants | ||
| The Incidence and Frequency of Serious Adverse Events (SAEs) Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment. | Basket 2 - Pancreatic Adenocarcinoma | 10 | Participants | ||
| The Incidence and Frequency of Serious Adverse Events (SAEs) Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment. | Basket 3 - Colorectal Adenocarcinoma | 12 | Participants | ||
| The Incidence and Frequency of Serious Adverse Events (SAEs) Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment. | Basket 4 - Esophageal Adenocarcinoma, Esophageal Squamous Cell, Gastroesophageal Junction | 0 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma | 4 | |
| Overall Study | STARTED | Basket 2 - Pancreatic Adenocarcinoma | 18 | |
| Overall Study | STARTED | Basket 3 - Colorectal Adenocarcinoma | 22 | |
| Overall Study | STARTED | Basket 4 - Esophageal Adenocarcinoma, Esophageal Squamous Cell Gastroesophageal Junction Adeno | 2 | |
| Overall Study | STARTED | Basket 5 - Gastric Adenocarcinoma | 1 | |
| Overall Study | STARTED | Stage 2 - Basket Expansion Based on Stage 1 | 0 | |
| Overall Study | COMPLETED | Basket 1: Cholangiocarcinoma Including Intrahepatic, Perihilar, Extrahepatic Cholangiocarcinoma | 0 | |
| Overall Study | COMPLETED | Basket 2 - Pancreatic Adenocarcinoma | 3 | |
| Overall Study | COMPLETED | Basket 3 - Colorectal Adenocarcinoma | 2 | |
| Overall Study | COMPLETED | Basket 4 - Esophageal Adenocarcinoma, Esophageal Squamous Cell Gastroesophageal Junction Adeno | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events468
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 | Anaemia | Blood and lymphatic system disorders | Stage 1 - Cholangiocarcinoma | 1 | 4 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 - Pancreas | 3 | 18 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 - Colorectal | 4 | 22 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 - Esophageal | 0 | 2 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 1 - Gastric | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Stage 2 - Basket Expansion Based on Stage 1 | 0 | 0 | |
| other | Tachycardia | Cardiac disorders | Stage 1 - Cholangiocarcinoma | 0 | 4 | 0 |
| other | Tachycardia | Cardiac disorders | Stage 1 - Pancreas | 1 | 18 | 1 |
| other | Tachycardia | Cardiac disorders | Stage 1 - Colorectal | 2 | 22 | 2 |
| other | Tachycardia | Cardiac disorders | Stage 1 - Esophageal | 0 | 2 | 0 |
1 to 10 of 468Source ClinicalTrials.gov
See all 468 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1 - Cholangiocarcinoma | 1 | 4 |
| Total, all-cause mortality | Stage 1 - Pancreas | 12 | 18 |
| Total, all-cause mortality | Stage 1 - Colorectal | 15 | 22 |
| Total, all-cause mortality | Stage 1 - Esophageal | 2 | 2 |
| Total, all-cause mortality | Stage 1 - Gastric | 1 | 1 |
| Total, all-cause mortality | Stage 2 - Basket Expansion Based on Stage 1 | 0 | 0 |
| Total, other adverse events | Stage 1 - Cholangiocarcinoma | 4 | 4 |
| Total, other adverse events | Stage 1 - Pancreas | 18 | 18 |
| Total, other adverse events | Stage 1 - Colorectal | 22 | 22 |
| Total, other adverse events | Stage 1 - Esophageal | 2 | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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/NCT05221320
GET https://conductscience.org/api/trials/v1/NCT05221320/results?page=2