Phase I/II study of lenalidomide and Cetuximab in patients with advanced solid tumors

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10065252Term: Solid tumor; MedDRA version: 9.1Level: LLTClassification code 10065147Term: Malignant solid tumor; Advanced solid tumors

• Registration Number: EUCTR2009-013423-31-AT
• Lead Sponsor: Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-25
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Disease Characteristics:
1.Patients signed informed consent.
2.Histologically or cytologically confirmed SCCHN, NSCLC, or metastatic colorectal adenocarcinoma.
3.At least one unidimensionally measurable lesion.
4.18 – 80 years of age.
5.Eastern Cooperative Oncology Group (ECOG) performance status of = 1.
6.Female subjects of childbearing potential† must:
•Understand that the study medication could have an expected teratogenic risk
•Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. An alternative would be an absolute and continued sexual abstinence. The following are effective methods of contraception*
Implant
Levonorgestrel-releasing intrauterine system (IUS)**
Medroxyprogesterone acetate depot
Tubal sterilisation
Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
* Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception.
•Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mIU/ml not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
•Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence
7.Male subjects must
•Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
•Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
8.All subjects must
•Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
•Agree not to share study medication with another person and to return all unused study drug to the investigator

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

Prior Treatment:
1.Use of chemotherapy, hormonal therapy, immunotherapy, or any other anticancer or experimental therapy within 28 days prior to study medication.
2.Active participation in another clinical trial.
3.Radiotherapy within 28 days prior to study medication.
4.Surgery within 28 days prior to study medication (minimally invasive procedures for the purpose of diagnosis or staging of the disease are permitted).
5.Prior therapy with pomalidomide (CC-4047), lenalidomide, or thalidomide.
Laboratory:
6.Absolute neutrophil count (ANC) < 1.5 x 109/L.
7.Platelet count < 100 x 109/L.
8.Creatinine Clearance < 50 mL/min.
9.Bilirubin > 1.5 x Upper Limit Normal (ULN) (> 2.0 x ULN in the presence of Gilbert’s Syndrome).
10.Serum aspartate transaminase (AST)/SGOT > 3.0 x ULN (> 5 x ULN in the presence of liver metastases).
Other Disease State:
11.Untreated, symptomatic brain metastases (brain imaging not required).
12.Venous thromboembolism within 6 months.
13.Current congestive heart failure (New York Heart Association class II-IV).
14.Uncontrolled hypertension
15.Prior malignancies within 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin or in-situ” carcinoma of the cervix or breast.
General:
16.Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study or confound the ability to interpret data from the study.
17.Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
18.Pregnant or lactating females.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the maximum tolerated dose (MTD) of lenalidomide administered in combination with cetuximab in patients with solid tumors;Secondary Objective: To determine the biological response to monotherapy with lenalidomide and to combination theraby with cetuximab by analysis of molecular markers regarding immunological effects and changes in angiogenic factors<br><br>To assess the safety and tolerability <br><br>To assess the clinical efficacy of lenalidomide adminstered in combination with cetuximab;Primary end point(s): •To determine the maximum tolerated dose (MTD) of lenalidomide administered in combination with cetuximab in subjects with solid tumors.<br><br>•To determine the optimal biologically active dose of lenalidomide given alone and in combination with cetuximab<br>