Locally Advanced or Metastatic Gastric or Gastroesophageal Adenocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10066354 Term: Adenocarcinoma of the gastroesophageal junction MedDRA version: 9.1 Level: LLT Classification code 10063916 Term: Metastatic gastric cancer
Conditions
Interventions
Product Name: liposomal irinotecan
Product Code: PEP02
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: irinotecan hydroc
Sponsors
PharmaEngine Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction. Have failed only one prior systemic chemotherapy for locally advanced or metastatic disease, including patients whose diseases recur within 6 months after the completion of (neo)adjuvant chemotherapy. Chemotherapy administered with concurrent radiotherapy is NOT considered as systematic chemotherapy. Have at least one measurable lesion according to the RECIST criteria. Aged 18 or above. ECOG performance status of 0,1 or 2. Normal ECG Life expectancy greater than or equal to 3 months Have adequate organ and marrow function as defined by the limits in the protocol. Ability to understand and willing to sign the Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. Have known brain metastasis. Have active multiple cancers or had treatment for other carcinomas within the last 5 years, except cured non-melanoma skin and treated in-situ cervical cancer. Have had previous irinotecan or taxane 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. Have pre-existing peripheral neuropathy (greater than grade 2) Have a history of allergic reaction to liposome product or other drugs formulated with polysorbate. Have uncontrolled intercurrent illness (specified in the protocol). Have received any investigational agents or have participated in any investigational drug study within 3 weeks of the start of the study. With intestinal obstruction. Have receives St John's Wort, CYP3A4 inducing convulsants (phenytoin, phenobarbital, and carbamazepine), rifampin and rifabutin within 2 weeks or ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem and verapamil within 1 week before the administration of study medications Pregnant or breastfeeding females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the objective tumour response in the single agent treatment of PEP02, irinotecan or docetaxel; Secondary Objective: To assess other efficacy variables i.e PFS, TTP etc To evaluate toxicities of study agents To explore dose intensities of study agents To characterise the pharmacokinetics of PEP02 and irinotecan To explore the association of pharmacogenetics of PEP02 and irinotecan including UGT-1A family ;Primary end point(s): Objective tumour response rate (ratio of the number of patients who have confirmed partial response or complete response according to RECIST criteria) | — |
Countries
Spain, United Kingdom
Outcome results
None listed