Trial · NCT02205463
KD019 and Trastuzumab in Patients With Esophagus, Gastroesophageal Junction and Stomach Cancer
NCT02205463, Phase 1, Withdrawn, NYU Langone Health
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. KD019 and Trastuzumab in Patients With Esophagus, Gastroesophageal Junction and Stomach Cancer. Trials, record NCT02205463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02205463
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- KD019 and Trastuzumab in Patients With Esophagus, Gastroesophageal Junction and Stomach Cancer
- NCT number
- NCT02205463
- Status
- Withdrawn
- Phases
- Phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Esophageal Cancer, Stomach Cancer
- Interventions
- KD019
- First posted
- 2014-07-31
- Last updated
- 2014-08-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) | 28 Days | To determine maximum tolerated dose (MTD) and RP2D of KD019 in combination with trastuzumab and mFOLFOX-6 when given to patients with HER2+ metastatic or unresectable adenocarcinoma of the esophagus, GEJ or stomach (gastric). |
| Secondary | Progression-Free Survival | 3 Years | Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Tumor assessments will be performed using RECIST criteria (Version 1.1). Imaging scans may be done within 4 weeks prior to the first dose of study drug (baseline) and then every 12 weeks (±7 days) after the first dose of study drug until documented progression. Responses will be confirmed by repeat assessments between 28 and 35 days after the response criteria are first met. |
| Secondary | Objective Response Rate | 3 Years | Overall response rates are defined as partial response plus complete response. Tumor response will be based on Response evaluation Criteria in Solid Tumors (RECIST 1.1). Response rates will be estimated with exact 95% confidence intervals for each dose level. Kaplan Meier curves will be used to summarize progression free survival. |
| Secondary | Duration of Response | 3 Years | The duration of overall response is measured from the time measurement are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Tumor response will be based on Response evaluation Criteria in Solid Tumors (RECIST 1.1). |
| Secondary | Clinical Benefit Rate | 3 Years | Clinical benefit rate is defined as complete response plus partial response plus stable disease \>16 weeks, and will be summarized descriptively. Tumor response will be based on Response evaluation Criteria in Solid Tumors (RECIST 1.1). |
| Secondary | Pharmacokinetics of KD019 | Multiple | Patients will undergo pharmacokinetics at the following time points: * Pre- 15 minutes pre-dosing: C1 D1, C1 D15 and then D1 only starting cycle 2 and thereafter Up to and including the cycle 6 visit. * Post- at 1 hour, 2 hours, and 4-6 hours post dosing: C1 D1, C1 D15 and 4-6 hours post dosing only on D1 only starting cycle 2 . * A PK sample will also be drawn if QTc(f) interval increases to an absolute value of \>500 msec. The concentration of KD019 in these samples will be used to confirm exposure to KD019 and to further characterize the plasma PK of KD019 in this subject population. * 30 days post treatment visit. |
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.
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/NCT02205463
GET https://conductscience.org/api/trials/v1/NCT02205463/registered