A phase II study of CP-751,871 in patients with recurrent and/or metastatic squamous head and neck carcinoma - IGF-1R protocol

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004707-59-BE

Enrollment

Registered

2008-10-14

Start date

2008-11-14

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

Palliative patients with recurrent and/or metastatic head and neck cancer after failure of first line standard chemotherapy. MedDRA version: 9.1 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV

Interventions

Product Code: CP-751,871 Pharmaceutical Form: Intravenous infusion Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -recurrent and or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation. -recurrence must be confirmed by anatomopathology(cytology or biopsy) -at least one measurable lesion by MRI or CT-scan -failed or relapsing after first line chemotherapy including a platinum or a taxane-based chemotherapy regimen -patients ineligible for chemotherapy could be included in first line -ECOG performance status 0-2, in stable medical condition -Patients must have an expected survival of at least 3 months -paraffin-embedded tumor tissue available for immunohistochemistery -patients must be over 18 years old and must be able to give written inform 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

Exclusion criteria: -non-squamous head and neck cancer -nasopharynx cancer -brain metastases -more than two lines of chemotherapy for palliative treatment(except if chemotherapy was given as a part of a multimodal treatment given with a curative intent) -surgery or irradiation or investigationnal drugs within 4 weeks before study inclusion -prior anti-IGF-1R therapy -other concomitant anti cancer therapy -other uncontrolled illnesses

Design outcomes

Primary

Measure	Time frame
Main Objective: -Determine the efficacy of CP-751,871 alone in patients with head and neck cancer in term of overall response rate;Secondary Objective: -Determine the safety profile of CP-751,871 alone in patients with head and neck cancer -Determine the efficacy of CP-751,871 alone in patients with head and neck cancer:progression-free survival and survival. -To perform translational research;Primary end point(s): -Determine the safety profile of CP-751,871 alone in patients with head and neck cancer -Determine the efficacy of CP-751,871 alone in patients with head and neck cancer:progression-free survival and survival. -To perform translational research	—

Measure

Time frame

Main Objective: -Determine the efficacy of CP-751,871 alone in patients with head and neck cancer in term of overall response rate;Secondary Objective: -Determine the safety profile of CP-751,871 alone in patients with head and neck cancer -Determine the efficacy of CP-751,871 alone in patients with head and neck cancer:progression-free survival and survival. -To perform translational research;Primary end point(s): -Determine the safety profile of CP-751,871 alone in patients with head and neck cancer -Determine the efficacy of CP-751,871 alone in patients with head and neck cancer:progression-free survival and survival. -To perform translational research

—

Countries

Belgium, France

Outcome results

None listed

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