A Phase 2 trial for patients with prostate cancer to receive study drugsof CP-751,871 in combination with Docetaxel/Prednisone orDocetaxel/Prednisone alone.

• Conditions: Metastatic hormone refractory (androgen indepedent) progressive prostate cancer (HRPC); MedDRA version: 14.0Level: LLTClassification code 10062904Term: Hormone-refractory prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-002717-21-DE
• Lead Sponsor: Pfizer Inc. 235 East 42nd Street, New York, NY 10017, USA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-28
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

1.Histologically confirmed adenocarcinoma of the prostate (a new
diagnostic biopsy
is not required).
2.Evidence of metastatic disease either on bone or CT scans.
3.At least 18 years old.
4.PSA above 5 ng/mL. 5.Progressive disease after at least 1 hormonal treatment (orchiectomy,
estrogens, LHRH therapy etc.) with documented testosterone levels less
than 50 ng/dL (equivalent to 1.7 nmol/L) and progressive disease
defined by the following:
- An increase in PSA>50% over nadir value on hormonal therapy
measured on 3 successive occasions at least 1 week a part. If the third
measurement is lower than the second, a fourth measurement will be
taken. Only if the fourth measurement is higher than the second, the
patient will be enrolled in the study.
- Disease progression as defined by RECIST
- Two or more new bone lesions
6.Concurrent use of LHRH agonist is required if the patient has not been
surgically castrated.
7.Eastern Cooperative Oncology Group (ECOG) performance status of 0,
1 or 2 determined within 2 weeks prior to enrollment (Appendix E).
8.Recovered to CTCAE of prior cancer therapy. CTCAEs > Grade 1 that are not considered a
safety risk by the sponsor and investigator will be allowed.
9.Stable level of pain for at least one week before enrollment.
10.Absolute neutrophil count of >1.5 x 109/L and platelets >100 x
109/L.
11.Adequate blood chemistry parameters as defined by:
- Creatinine <1.7 mg/dL (equivalent to 151 micromol/L). If creatinine is
>1.7 mg/dL, the calculated creatinine clearance must be >40 ml/min
from the Cockcroft Gault or MDRD formulas (Appendix D).
- Bilirubin - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
<1.5 x ULN
12. Hemoglobin >10 g/dL.
13. Written and voluntary informed consent understood, signed and
dated.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 59
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 145

Exclusion Criteria

1.Prior chemotherapy or radioisotopes treatment for prostate cancer.
2.Prior anti IGF 1R and antibody based investigational therapies. Other
investigational therapies (targeted or vaccine), unless otherwise agreed
by investigators and sponsor, will require 4 weeks wash out period
before enrollment.
3.Antiandrogen therapy (eg, flutamide) for primary cancer within 4
weeks prior to enrollment (6 weeks in the case of bicalutamide,
nilutamide or other long acting anti androgens).
4.Radiation therapy to more than 25% of the bone marrow.
5.Local radiation within 2 weeks of enrollment.
6.Surgery within 4 weeks prior to study enrollment or not fully recovered
from side effects of previous procedures.
7.Use of products known to affect PSA levels within 4 weeks of
enrollment (eg, PC Calm, PC Plus, PC SPES, finasteride).
8.A serious uncontrolled medical disorder or active infection that would
impair the ability to receive study treatment.
9.Significant active cardiac disease including: uncontrolled high blood
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pressure (ie, systolic blood pressure >160 mmHg, 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.
10.Subjects who are receiving chronic high dose immunosuppressive
steroid therapy. Use of high dose corticosteroids within 2 weeks prior to
enrollment (=100 mg prednisone per day or >40 mg dexamethasone per
day). Previous steroid treatment is allowed but must be stopped at
enrollment. Low dose steroid use for the control of nausea and vomiting
(eg, dexamethasone 20 mg/day for up to 5 days) will be allowed.
Topical steroid use is permitted. Inhaled steroids are permitted. Use of
dexamethasone as pre medication is not an exclusion criterion.
11. Known severe hypersensitivity reactions to docetaxel or other drugs
formulated in polysorbate 80.
12. Medical contraindication to any of the docetaxel pre medications.
13. Neuropathy greater than Grade 1 or evidence of unstable
neurological symptoms within 4 weeks prior to enrollment.
14. Brain metastasis. Unevaluated central nervous system (CNS)
symptoms suggestive of brain metastases within 2 weeks prior to
enrollment. CNS symptoms must be evaluated with a computerized
tomography (CT) scan or magnetic resonance imaging (MRI).
15. Dementia or significantly altered mental status that would limit the
understanding or rendering of informed consent and compliance with the
requirements of this protocol.
16. Subjects with reproductive potential who are not using adequate
barrier methods on treatment.
17. Active malignancy other than prostate cancer within the past five
years with the exception of non melanoma skin cancer (basal or
squamous-cell skin cancer).
18. Subjects who have been admitted to an institution by virtue of an
order issued by either the judicial or administrative authorities.

Study & Design

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