A PHASE II, SINGLE ARM STUDY OF CP-751,871 IN PATIENTS WITH REFRACTORY METASTATIC ADENOCARCINOMA OF THE COLON OR RECTUM

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2007-004787-49-GB
• Date of registration: 26/11/2007
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc - 235 East 42nd Street, New York, NY 10017
• Public title: A PHASE II, SINGLE ARM STUDY OF CP-751,871 IN PATIENTS WITH REFRACTORY METASTATIC ADENOCARCINOMA OF THE COLON OR RECTUM
• Scientific title: A PHASE II, SINGLE ARM STUDY OF CP-751,871 IN PATIENTS WITH REFRACTORY METASTATIC ADENOCARCINOMA OF THE COLON OR RECTUM
• Date of first enrolment: 08/01/2008
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004787-49
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age >18 years
2. Histologically or cytologically confirmed adenocarcinoma arising in the colon or rectum. Histological evaluation (new biopsy) at the time of enrollment is not required.
3. Radiographic evidence of metastatic, progressive disease following standard therapies. Patients in the United States will have been treated previously with, or have a significant known contraindication to, a fluoropyrimidine, irinotecan and oxaliplatin. These patients may or may not have been treated with bevacizumab (Avastin), cetuximab (Erbitux) and/or Panitumumab (Vectibix). Patients outside of the United States will have been treated with, or have a contraindication to, at least 2 prior chemotherapy regimens with whichever drugs are routinely used and available in standard practice in that country.
4. ECOG performance status 0-1.
5. At least three weeks since the last therapy regimen prior to enrollment. Patients must have recovered to NCI CTCAE v3.0< or equal Grade 1 from all acute toxicities (excluding toxicities that are not considered a safety risk by the sponsor and investigator such as alopecia or residual peripheral neuropathy resulting from prior systemic therapy) or the toxicity must be deemed irreversible by the investigator.
6. At least one week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
7. Patients must have adequate hematologic, renal and liver function determined within 14 days prior to enrollment, defined as:
a. Absolute neutrophil count > or equal 1.0 x 10e9 cells/L.
b. Platelets > or equal 50 x 10e9/L.
c. Hemoglobin > or equal 8 g/dL.
d. Aspartate and alanine aminotransferases (AST, ALT) < or equal 5 x ULN (upper limit of normal).
e. Total serum bilirubin < or equal 2 x ULN
f. Serum creatinine < or equal 2.0 mg/dL.
8. Negative pregnancy test within 72 hours of initial dose of CP-751,871 for females of child-bearing potential. Patients must be surgically sterile or postmenopausal females, or must agree to use double barrier contraception during the period of therapy and for 5 months following the last dose of the study drug. Double barrier contraception is defined as male condom plus spermicide in combination with a female condom, diaphragm, or cervical cap; or male condom plus spermicide in combination with an intrauterine device. Within these limits, the specific form of contraception employed is left to the discretion of the patient or the principal investigator.
9. Evidence of a personally signed and dated informed consent indicating that the patient (or a legally acceptable representative) has been informed of all the pertinent aspects of the study.
10. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

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:
1. Concomitant treatment with other anti-cancer therapy.
2. Prior anti IGF-IR based investigational therapy. Other investigational therapies (targeted or vaccine), unless otherwise agreed by investigators and sponsor, will require 4 weeks wash-out period or 5 half-lives of the agent, which ever is sooner, before enrollment.
3. Symptomatic brain metastases. Brain metastases stable for <2 weeks before dosing or requiring concurrent steroid therapy or with clinical symptoms. Clinical symptoms suggestive of new brain metastasis within 2 weeks of enrollment. If such evidence exists, new brain metastasis must be ruled out by a CT scan or MRI. Patients that develop brain metastasis during the study will not need to have their treatment interrupted to receive a course of cranial radiation.
4. Major surgery within 4 weeks prior to study enrollment or not fully recovered from side effects of previous procedures.
5. Previous or current malignancies at sites other than basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrent disease for 12 months.
6. Significant active cardiac disease including: uncontrolled high blood pressure (ie, systolic blood pressure >180 mm Hg, diastolic blood pressure >95 mm Hg), unstable angina, deep venous thrombosis, pulmonary embolism, cerebro vascular attack, valvular disease, congestive heart failure, myocardial infarction (within the previous 6 months), or serious cardiac arrhythmias.
7. Patients who are receiving chronic high-dose systemic immunosuppressive steroid therapy (> or equal 100 mg prednisone per day or >40 mg dexamethasone per day). Use of high-dose corticosteroids within 2 weeks prior to enrollment.
8. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
9. Pregnancy or breast feeding.
10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Refractory colorectal cancer
MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer

Intervention(s)

Product Code: CP-751,871
Pharmaceutical Form: Solution for infusion
Current Sponsor code: CP-751,871
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Primary end point(s): Six-month overall survival

Secondary Objective: To assess the safety and tolerability of multiple intravenous doses of CP 751,871
To evaluate the efficacy of CP-751,871 in terms of progression free survival (PFS)
To evaluate the efficacy of CP-751,871 in terms of overall survival (OS)
To evaluate the efficacy of CP-751,871 in terms of objective response
To collect pharmacokinetics (PK) data of CP 751,871 for future population PK meta-analysis
To monitor the immunogenicity of CP 751,871 in terms of producing an anti-drug antibody (ADA) response
To explore the feasibility of quantification of circulating tumor cells (CTCs) and that of CTCs expressing the IGF-IR

Main Objective: To evaluate six-month overall survival in refractory, metastatic colorectal cancer patients who receive CP-751,871.

Secondary ID(s)

A4021006

2007-004787-49-ES