A Randomised Phase II Study of PEP02, Irinotecan or Docetaxel as a Second Line Therapy in Patients with Locally Advanced or Metastatic Gastric of Gastroesophageal Junction Adenocarcinoma

Phase 1

• Conditions: ocally 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

• Registration Number: EUCTR2006-006452-35-GB
• Lead Sponsor: PharmaEngine Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 123

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the objective tumour response in the single agent treatment of PEP02, irinotecan or docetaxel;<br> Secondary Objective: To assess other efficacy variables i.e PFS, TTP etc<br> To evaluate toxicities of study agents<br> To explore dose intensities of study agents<br> To characterise the pharmacokinetics of PEP02 and irinotecan<br> To explore the association of pharmacogenetics of PEP02 and irinotecan including UGT-1A family<br> ;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)