A Phase 2 Single-Arm study of gemcitabine in combination with Oxaliplatin in Pediatric patients with relapsed or refractory neuroblastoma or miscellaneous solid non-CNS tumors - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2005-005219-36-IT
• Date of registration: 09/05/2006
• Prospective Registration: No
• Primary sponsor: ELI LILLY
• Public title: A Phase 2 Single-Arm study of gemcitabine in combination with Oxaliplatin in Pediatric patients with relapsed or refractory neuroblastoma or miscellaneous solid non-CNS tumors - ND
• Scientific title: A Phase 2 Single-Arm study of gemcitabine in combination with Oxaliplatin in Pediatric patients with relapsed or refractory neuroblastoma or miscellaneous solid non-CNS tumors - ND
• Date of first enrolment: 23/01/2006
• Target sample size: 49
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-005219-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
1 Histologically proven malignancy at diagnosis either neuroblastoma or other non-CNS solid tumors excluding osteosarcoma . 2 Measurable primary and/or metastatic disease 3 Relapsed or refractory tumors in which standard approaches to treatment have failed. 4 No more than one salvage therapy for relapsed or refractory disease. 5 6 months to 18 years of age. 6 Lansky play score 70 , or Eastern Cooperative Oncology Group ECOG performance status 1 where more appropriate . 7 Life expectancy 3 months. 8 Adequate organ function
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1 Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. 2 Concurrent administration of any other antitumor therapy. 3 Have a serious concomitant systemic disorder for example, active infection including HIV, or cardiac disease that, in the opinion of the investigator, would compromise the patient s ability to complete the study. 4 Have symptomatic brain metastases. 5 Pre-existing sensory or motor neuropathy Grade 2 excluding neuropathy due to disease .


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with neuroblastoma and Miscellaneous Solid NOn-CNS tumor
MedDRA version: 6.1 Level: HLGT Classification code 10027655

Intervention(s)

Trade Name: GEMZAR 1G POLV. EV 1 FL
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Gemcitabine
CAS Number: 122111-03-9
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Trade Name: ELOXATIN IV 1 FL 100 MG
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Oxaliplatin
CAS Number: 61825-94-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: to characterize the safety and adverse event profile of the combination to assess the following time-to-event endpoints o duration of response o time to treatment failure o time to progressive disease o overall survival.

Main Objective: The primary objective is to assess the antitumor activity, as measured by objective response rate, of the gemcitabine plus oxaliplatin combination in pediatric patients with neuroblastoma. The antitumor activity of the miscellaneous solid non-CNS tumor cohort will be assessed by describing the responses seen in each tumor type.

Primary end point(s): Assessment of the efficacy of the combination

Secondary ID(s)

B9E-MC-S378

2005-005219-36-DE