Clinical trial NCT01360827: EMD 1201081 + 5-FU + Cisplatin + Cetuximab in Subjects With Recurrent / Metastatic Squamous Cell Carcinoma of the Head and Neck
Official title: Phase Ib Trial of Multiple-ascending Doses of EMD 1201081 in Combination With 5-FU/Cisplatin and Cetuximab in First-line Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Safety
tolerability
maximum tolerated dose of EMD 1201081
TLR9 agonists
squamous cell carcinoma of the head and neck
First line subjects
recurrent/metastatic
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN).
* Recurrent and/or metastatic SCCHN, not suitable for local therapy.
* At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0).
* Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry.

Exclusion Criteria:

* Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry.
* Nasopharyngeal carcinoma.
* Medical history of diagnosed interstitial lung disease.
* Known hypersensitivity against any of the components of the trial treatment.
* Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed).
* Relevant cardiovascular co-morbidities.
* Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent.
* Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B.

Primary outcomes:
measure: Maximum-tolerated-dose (MTD) at 0.16 mg/kg cohort size testing
timeFrame: 3 weeks
measure: Maximum-tolerated-dose (MTD) at 0.32 mg/kg cohort size testing
timeFrame: 3 weeks
measure: Maximum-tolerated-dose (MTD) at 0.48 mg/kg cohort size testing
timeFrame: 3 weeks
measure: Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Baseline up to 49 days after last study drug administration
Secondary outcomes:
measure: Number of subjects with best overall response
timeFrame: 8 months
measure: Pharmacokinetic parameters: Cmax, Tmax and AUC (0-t)
timeFrame: Days 1, 8 and 15
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinical Research Unit and Pharmacology Lab EA 3035 Institut Claudius Regaud
Study officials:
affiliation: Clinical Research Unit and Pharmacology Lab EA 3035, Institut Claudius Regaud, Toulouse, France
name: Dr. Jean-Pierre Delord
role: PRINCIPAL_INVESTIGATOR
References: