Trial · NCT07594548
Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
NCT07594548, Phase 1, Not yet recruiting, Northwestern University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma. Trials, record NCT07594548. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07594548
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
- NCT number
- NCT07594548
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 18 participants, estimated
- Lead sponsor
- Northwestern University
- Conditions
Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Locally Advanced Esophageal Adenocarcinoma, Locally Advanced Gastric Adenocarcinoma, Locally Advanced Gastroesophageal Junction Adenocarcinoma, Metastatic Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Unresectable Esophageal Adenocarcinoma, Unresectable Gastric Adenocarcinoma, Unresectable Gastroesophageal Junction Carcinoma
- Interventions
- Biospecimen Collection, Computed Tomography, Futibatinib, Magnetic Resonance Imaging, Paclitaxel, Ramucirumab
- First posted
- 2026-05-18
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose | From cycles 1 day 8 (start of Futibatinib) to cycle 2 day 8 (cycle length = 28 days) | Defined as the highest dose that causes dose-limiting toxicities (DLTs) in \< 2 of 6 subjects. Will be estimated using the Bayesian Optimal Interval algorithm based on observed DLTs. The frequency of DLTs at each dose level will be summarized using descriptive statistics, including proportions and confidence intervals. |
| Primary | Recommended phase 2 dose | Up to 2 years | |
| Secondary | Incidence of adverse events | Up to 2 years | Defined as the frequency of adverse events by type, severity (grade), timing, and attribution to \[study drugs, according the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. |
| Secondary | Objective response rate | From treatment initiation until the response has been confirmed, the patient experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation, up to 2 years after completion of study treatment | Defined as the proportion of treated patients who experience an objective response (confirmed complete response \[CR\] or confirmed partial response \[PR\]) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be calculated with corresponding 95% confidence intervals. |
| Secondary | Duration of response (DOR) | From the first scan showing CR or PR to disease progression or death, up to 2 years after completion of study treatment | Response is defined as confirmed complete response or confirmed partial response per RECIST 1.1; and disease progression is defined as progressive disease per RECIST 1.1. Will be summarized using the Kaplan-Meier method, with estimates of median DOR and corresponding 95% confidence intervals. |
| Secondary | Progression free survival (PFS) | From treatment initiation and the earlier of the day of first documented disease progression or death, up to 2 years after completion of study treatment | PFS will be calculated based on the Kaplan-Meier estimates of PFS. Disease progression is defined as progressive disease per RECIST 1.1, other documented clinical or radiographical progression per physician judgement, or death due to disease. |
| Secondary | Overall survival (OS) | From start of treatment and the date of death from any cause, up to 2 years after completion of study treatment | Median OS will be calculated based on the Kaplan-Meier estimates of OS. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 |
Source NIH RePORTER
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07594548
GET https://conductscience.org/api/trials/v1/NCT07594548/registered