A PHASE 2, PROSPECTIVE, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, ACTIVE- CONTROL, PARALLEL-GROUP STUDY TO DETERMINE THE SAFETY OF AND TO SELECT A TREATMENT REGIMEN OF CC-4047 EITHER AS SINGLE-AGENT OR IN COMBINATION WITH PREDNISONE TO STUDY FURTHER IN SUBJECTS WITH MYELOFIBROSIS WITH MYELOID METAPLASIA - ND

• Register: EUCTR
• Last refreshed on: 26 November 2013
• Main ID: EUCTR2006-004553-17-IT
• Date of registration: 04/07/2007
• Prospective Registration: No
• Primary sponsor: Celgene Corporation
• Public title: A PHASE 2, PROSPECTIVE, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, ACTIVE- CONTROL, PARALLEL-GROUP STUDY TO DETERMINE THE SAFETY OF AND TO SELECT A TREATMENT REGIMEN OF CC-4047 EITHER AS SINGLE-AGENT OR IN COMBINATION WITH PREDNISONE TO STUDY FURTHER IN SUBJECTS WITH MYELOFIBROSIS WITH MYELOID METAPLASIA - ND
• Scientific title: A PHASE 2, PROSPECTIVE, RANDOMIZED, MULTICENTER, DOUBLE-BLIND, ACTIVE- CONTROL, PARALLEL-GROUP STUDY TO DETERMINE THE SAFETY OF AND TO SELECT A TREATMENT REGIMEN OF CC-4047 EITHER AS SINGLE-AGENT OR IN COMBINATION WITH PREDNISONE TO STUDY FURTHER IN SUBJECTS WITH MYELOFIBROSIS WITH MYELOID METAPLASIA - ND
• Date of first enrolment: 07/03/2007
• Target sample size: 80
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004553-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no

Countries of recruitment

Austria, Germany, Italy, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Must be 61619;18 years of age at the time of voluntarily signing an Institutional Review Board/Independent Ethics Committee IRB/IEC -approved informed consent form. 2. Must be diagnosed with myelofibrosis requiring therapy including myelofibrosis with myeloid metaplasia MMM , de novo presentation i.e., agnogenic myeloid metaplasia AMMM , and developing after an antecedent history of Polycythemia Vera i.e., post-polycythemic myeloid metaplasia PPMM , or Essential Thrombocythemia i.e., post thrombocythemic myeloid metaplasia PTMM . 3. Eligibility is based on local pathology review of bone marrow aspirate and biopsy. Adequate slides also to be sent to Central Reviewer for confirmation . 4. Screening total hemoglobin level 10g/dL or transfusion-dependent anemia defined as per IWG criteria. Transfusion dependency defined by a history of at least 2 units of red blood cell transfusions in the last 28 days for hemoglobin 8.5 g/dL that was not associated with overt bleeding . 5. Must have adequate organ function as demonstrated by the following 8804; 14 days prior to starting study drug 61623; ALT SGPT /AST SGOT 61603; 3 x upper limit of normal ULN , unless upon judgment of the treating physician, it is believed to be due to extramedullary hematopoiesis EMH . 61623; Total Bilirubin 3x ULN or Direct Bilirubin 2 x ULN 61623; Serum creatinine 8804; 2.0 mg/dL 61623; Absolute neutrophil count 8805; 1,000/ 956;L 8805; 1 x 109/L . 61623; Platelet count 8805; 50,000 / 956;L 8805; 50 x 109/L . 6. Subjects must be willing to receive transfusion of blood products 7. ECOG performance status PS of 0, 1, or 2 at screening. 8. Must be able to adhere to the study visit schedule and other protocol requirements. 9. No active malignancies with the exception of controlled prostate cancer , basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast. 10. Females of childbearing potential FCBP must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study 1 for at least 28 days before starting study drug; 2 while participating in the study; and 3 for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method i.e. intrauterine device IUD , hormonal birth control pills, injections, or implants , tubal ligation, partner s vasectomy and one additional effective barrier method i.e. latex condom, diaphragm, cervical cap . FCBP must be referred to a qualified provider of contraceptive methods if needed.
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. Known positive status for HIV, hepatitis B carrier, or active hepatitis C infection. 2. Previous untoward reaction to corticosteroid specifically, prednisone therapy that was severe enough, in the opinion of the treating physician, to preclude study participation. 3. The use of any growth factors, cytotoxic chemotherapeutic agents e.g. hydroxyurea and anagrelide , corticosteroids, or experimental drug or therapy within a minimum of 28 days of starting CC-4047 and/or lack of recovery from all toxicity from previous therapy to grade 1 or better e.g. alpha interferon may require 84 days or longer for washout . 4. Prior therapy with CC-4047, lenalidomide or thalidomide for MMM. Prior prednisone use as a therapy for MMM is allowed, but not within 28 days of starting CC-4047 . 5. History of deep vein thrombosis or pulmonary embolism. 6. Any serious medical condition or psychiatric illness that would prevent, as judged by the treating physician the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 7. Pregnant or lactating females


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

Health Condition(s) or Problem(s) studied

MYELOFIBROSIS WITH MYELOID METAPLASIA
MedDRA version: 9.1 Level: LLT Classification code 10028537 Term: Myelofibrosis

Intervention(s)

Product Code: CC-4047
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Thalidomide
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Product Code: CC-4047
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Thalidomide
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Product Name: Prednisone
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Prednisone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: 61623; To determine the safety of CC-4047 as single-agent and in combination with prednisone in the treatment of myelofibrosis with myeloid metaplasia.

Primary end point(s): Best overall response as determined by International Working Group Criteria over the first 6 cycles 168 days of study treatment.

Main Objective: 61623; To select a treatment regimen of CC-4047 either as single-agent or in combination with prednisone to study further in subjects with myelofibrosis with myeloid metaplasia.

Secondary ID(s)

2006-004553-17-GB

CC-4047-MMM-001