SYF9e63bc7995084e4191f22afacb9a93a2Registry ID: 2024-513515-27-00|UnknownPhase 2Results
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interventional
N/A
1 country
1
The primary objective was to assess the 6-month overall survival and 4-month quality of life of ramucirumab alone or in combination with paclitaxel.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 19, 2024
Actual (reported)Six months survival rate and quality of life at 4 months
description of observed toxicities graded according to NCI-CTC V4 and description of SAEs
dose intensity will be assessed by the ratio (expressed as a %): actual dose(DR)/theoretical dose(DT) for each chemotherapy product (Ramucirumab or Paclitaxel)
The time to deterioration in autonomy was defined as the time between the date of randomisation and the date on which the IADL score decreased by at least 1 point compared with the score calculated at inclusion. Patients who were alive or who died without deterioration in autonomy were censored at the date of the last IADL assessment or at the date of death.
Time to deterioration of quality of life scores is defined as the time between the date of randomisation and the date of deterioration of the EORTC QLQC30 and ELD 14 scores by 10 points relative to the score at inclusion. Patients alive or who died without deterioration will be censored at the date of last QoL assessment or at the date of death.
Overall survival is defined as the time from the date of randomisation to the date of death from any cause. Patients lost to follow-up or alive at the time of analysis will be censored at the date of last news.
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Formulated product
Cyramza 10 mg/ml concentrate for solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
PACLITAXEL AHCL 6 mg/ml, solution à diluer pour perfusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Cyramza 10 mg/ml concentrate for solution for infusion
Named ingredient: Ramucirumab
View registry recordPACLITAXEL AHCL 6 mg/ml, solution à diluer pour perfusion
Named ingredient: Paclitaxel
View registry recordCentre Hospitalier Universitaire De Rennes
Rennes, 35000, France
Manon PELKOWSKI
First Submitted
June 19, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
A study to investigate the efficacy of ramucirumab in combination with dacarbazine in patients with progressive well-differentiated metastatic neuroendocrine tumors of the pancreas
Contact the study team to confirm eligibility.