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Sorafenib plus paclitaxel metronomic chemotherapy in adreno-cortical-carcinoma patients progressing after 1st or snd line cytotoxic chemotherapy - PAXO

Sorafenib plus paclitaxel metronomic chemotherapy in adreno-cortical-carcinoma patients progressing after 1st or snd line cytotoxic chemotherapy - PAXO

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-000759-91-IT
Enrollment
25
Registered
2008-07-28
Start date
2008-04-24
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACC MedDRA version: 9.1 Level: SOC Classification code 10014698 Term: Endocrine disorders MedDRA version: 9.1 Level: LLT Classification code 10001326 Term: Adrenal carcinoma

Interventions

Trade Name: NEXAVAR*112CPR RIV 200MG Pharmaceutical Form: Tablet INN or Proposed INN: sorafenib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Trade Name: T

Sponsors

AZIENDA OSPEDALIERA S. LUIGI GONZAGA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - histologically confirmed diagnosis of ACC - locally advanced or metastatic disease not amenable to radical surgery resection 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: - history of prior malignancy - severe renal insufficiency

Design outcomes

Primary

MeasureTime frame
Main Objective: To determine the activity and side effects of Sorafenib plus weekly Paclitaxel;Secondary Objective: To assess che clinical benefit as misured by a non progressing rate after 4 months;Primary end point(s): - survival without disease mprogression

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026