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

PharmaEngine Inc.0 个研究点目标入组 123 人开始时间: 2007年4月26日最近更新: 2019年11月25日

适应症

试验速览

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•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.
•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

•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.

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