Clinical trial · Interventional
Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer
A Phase Ib, Multi-center, Open-label Study of Z650 and Gemcitabine in Advanced Pancreatic Cancer
NCT04131192CI-TRIAL-00058314terminatedPhase 1ClinicalTrials.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): Combined with the analysis of the existing data of the trial, there was no obvious advantage compared with the clinical standard treatments, and the clinical trial was decided to be terminated based on the benefit of the subjects.
Summary
Brief summary (as posted)
This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic 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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Z650 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- z650 and Gemcitabine
- description
- Z650:250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal Gemcitabine: intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle FOR the 4-6 cycles
- interventionNames
- Drug: Z650
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- Rate of dose limiting toxicities of each subject
- timeFrame
- 21 days
- description
- Rate will be assessed through summaries of adverse events, clinical laboratory abnormalities, and changes in physical exam and vital signs. All subjects who receive a single dose of study medication will be considered evaluable for safety.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 18 ≤ age ≤ 75 years old, male or female is not limited; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Life expectancy of ≥ 12 weeks Pathologically confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally recurrent, or metastatic disease. Exclusion Criteria: adjuvant treatment with gemcitabine within 6 months prior to the first dose; Radiotherapy and anti-cancer Chinese patent medicine treatment were performed within 4 weeks before the first dose; Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction); Doppler ultrasound evaluation of Left ventricular ejection fraction \< 50%
References
Publications (0)
Data not yet available
No reference posted for this study.