Clinical trial · Interventional
Study of PEP02, Irinotecan or Docetaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
A Randomized Phase II Study of PEP02, Irinotecan or Docetaxel as a Second Line Therapy in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess objective tumor response in the single agent treatment of PEP02, irinotecan, or docetaxel for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| irinotecan | Drug | Irinotecan | ALIAS |
| PEP02 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1. PEP02
- description
- liposome irinotecan
- interventionNames
- Drug: PEP02
- type
- ACTIVE_COMPARATOR
- label
- 2. irinotecan
- interventionNames
- Drug: irinotecan
- type
- ACTIVE_COMPARATOR
- label
- 3. docetaxel
- interventionNames
- Drug: docetaxel
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric or gastroesophageal junction * Failed to only one systemic chemotherapy for locally advanced or metastatic disease, including patients whose diseases recur within 6 months after (neo)adjuvant chemotherapy. Chemotherapy administered with concurrent radiotherapy is NOT considered as systemic chemotherapy. * Have at least one measurable lesion according to the RECIST criteria * Aged above or equal to 18 years, at the time of acquisition of informed consent * With ECOG performance status 0, 1, or 2 * Life expectancy equal to or more than 3 months * With adequate organ and marrow function as defined below: * With ability to understand and the willingness to sign a written Informed Consent Form Exclusion Criteria: * Had systemic chemotherapy within 3 weeks before the commencement of study treatment * Had radiotherapy within 4 weeks before the commencement of study treatment * With known brain metastasis * With active multiple cancers or had treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer * With prior irinotecan or taxane (paclitaxel, docetaxel) treatment * Have received irradiation affecting \> 30% of the active bone marrow * Had major surgery within 4 weeks of the start of study treatment (laparotomy, line placement is not considered major surgery) * Have not recovered from prior treatments * With preexisting peripheral neuropathy \> grade 2 * With history of allergic reaction to liposome product or other drugs formulated with polysorbate * With uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, active gastrointestinal bleeding, watery stools, central nervous system disorders or psychiatric illness/social situation that would limit compliance with study requirements or judged to be ineligible for the study by the investigator * Have received any investigational agents within 3 weeks preceding the start of study treatment * Pregnant or breastfeeding females (a pregnancy test must be performed on all female patients who are of child-bearing potential before entering the study, and the result must be negative) * With intestinal obstruction * Have received St. John's Wort, CYP3A4 inducing anticonvulsants (phenytoin, phenobarbital, and carbamazepine), rifampin and rifabutin within two weeks, or ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem and verapamil within one week before the administration of study medications
References
Publications (1)
- DERIVEDRoy AC, Park SR, Cunningham D, Kang YK, Chao Y, Chen LT, Rees C, Lim HY, Tabernero J, Ramos FJ, Kujundzic M, Cardic MB, Yeh CG, de Gramont A. A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma. Ann Oncol. 2013 Jun;24(6):1567-73. doi: 10.1093/annonc/mdt002. Epub 2013 Feb 13. PMID 23406728