Clinical trial · Interventional
Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer
A Phase 1B Study of Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer
NCT02489214CI-TRIAL-00066218terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Corporate policy adjustments
Summary
Brief summary (as posted)
This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib in advanced gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| donafenib tosilate tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- donafenib tosilate tablets
- description
- 200mg bid
- interventionNames
- Drug: donafenib tosilate tablets
Primary outcomes (1)
- measure
- Number of Participants with Adverse Events
- timeFrame
- 54 weeks
- description
- patients with adverse events/all patients\*100%
Secondary outcomes (2)
- measure
- Tumor response
- timeFrame
- 54 weeks
- description
- complete response and partial response patients/all patients\*100%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * All patients provided written, informed consent. * Have histological or cytological documentation of gastric adenocarcinoma; * Have received currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects. * Standard therapies include as many of the following as were licensed: a fluoropyrimidine,oxaliplatin,irinotecan, paclitaxel,docetaxel;and trastuzumab for patients who had Her-2 positive tumours; * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Life expectancy of at least 3 months; * Have adequate bone-marrow, liver, and renal function at the start of the trial. * Prothrombin time international normalized ratio≤1.5; Exclusion Criteria: * Patients with brain metastases. * Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks. * Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin \>1.5 times upper limit of reference range, aspartate or alanine aminotransferase\>2.5 times the upper limit of normal if no demonstrable liver disease).
References
Publications (0)
Data not yet available
No reference posted for this study.