A phase 2, multicenter, open-label, single arm, two-stage study to evaluate the efficacy and safety of CC-4047 (Pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to systemic anticancer therapy

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-005670-31-AT
• Date of registration: 21/07/2008
• Prospective Registration: Yes
• Primary sponsor: Celgene Corporation
• Public title: A phase 2, multicenter, open-label, single arm, two-stage study to evaluate the efficacy and safety of CC-4047 (Pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to systemic anticancer therapy
• Scientific title: A phase 2, multicenter, open-label, single arm, two-stage study to evaluate the efficacy and safety of CC-4047 (Pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to systemic anticancer therapy
• Date of first enrolment: 13/03/2009
• Target sample size: 167
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005670-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion criteria:
· Must understand and voluntarily sign an informed consent form

· Must be = 18 years of age at the time of consent

· Must be able to adhere to the study visit schedule and requirements of the protocol

· Must have histologically confirmed soft tissue sarcoma

· Must have locally recurrent, unresectable or metastatic soft tissue sarcoma, and
have failed or relapsed after a minimum of one and a maximum of 3 prior systemic
anticancer therapy regimens

- Prior treatment must not have included any anti-angiogenic therapy
- Prior treatment must have included both doxorubicin and ifosfamide
- Adjuvant therapy containing doxorubicin and/or ifosfamide will be considered as prior systemic anticancer therapy regimen if subject has relapsed within 12 months of the completion of the adjuvant therapy

· Must have measurable or evaluable disease determined as per RECIST criteria

· Must have documented disease progression (PD) determined as per RECIST
criteria within 3 months prior to study enrollment

· Must have an Eastern Cooperative Oncology Group (ECOG) performance status
score of 0 or 1

· Must have life expectancy of = 12 weeks

· A female of childbearing potential (FCBP) must agree to use two reliable forms
of contraception simultaneously or to practice complete abstinence from
heterosexual intercourse for at least 28 days before starting study drug, while
participating in the study and for at least 28 days after the treatment discontinuation visit. FCBP must agree to pregnancy testing (weekly for the 1st 28 days) and contraceptive counseling every 28 days during the study. FCBP must also refrain from donating blood and or eggs or ovum while participating in the study and for at least 28 days after the treatment discontinuation visit

· Males must agree to use a latex condom during any sexual contact with FCBP
while participating in this study and for at least 28 days following the treatment
discontinuation visit even if he has undergone a successful vasectomy. Males must
also agree to refrain from donating blood, semen, or sperm while participating in
this study and for at least 28 days after the treatment discontinuation visit

· Study subjects must agree to not share study drug with anyone during participation
in the study

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:
· Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the study subject from signing the informed consent form

· Pregnant or lactating females

· Prior therapy with Thalidomide or Lenalidomide

· Prior use of any anti-angiogenic therapy

· Prior use of experimental/investigational drug therapy < 3 months prior to
treatment initiation

· Prior chemotherapy, biologic or immunotherapy < 3 weeks prior to treatment
initiation

· Prior radiotherapy < 3 weeks prior to treatment initiation

· Prior major surgery < 3 weeks prior to treatment initiation

· Known hypersensitivity to any IMiDs

· Unable to receive prophylactic anti-coagulation

· Any of the following laboratory values:
- Absolute neutrophil count (ANC) < 1.5 x 10^9 cells/L
- Platelet count < 100 x 10^9 cells/L
- Creatinine Clearance < 50 mL/min by Cockcroft-Gault formula
- Total bilirubin > 1.5 x the upper limit of normal (ULN) or > 2.0 x ULN in the
presence of demonstrable liver metastases
- Aspartate transaminase (serum glutamate oxaloacetic transaminase )(AST [SGOT]) and alanine transaminase (serum glutamate pyruvic transaminase)
(ALT [SGPT]) > 3.0 x ULN or > 5.0 x ULN in the presence of demonstrable liver metastases

· Active infection requiring systemic antibiotics

· Known HIV, hepatitis B virus (HBV) and/or
hepatitis C virus (HCV) infection

· Known active CNS metastases

· Any of following subtype of sarcomas:
- Osteosarcoma
- Chondrosarcoma
- Kaposi’s sarcoma associated with HIV
- GIST
- Mesothelioma

· Prior history of malignancies, unless the study subject has been free of the disease
for 2 years. Exceptions include the following:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histological finding of prostate cancer (Tumor Node Metastasis [TNM] stage of T1a or T1b)


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

Health Condition(s) or Problem(s) studied

Locally recurrent, unresectable or metastatic soft tissue sarcomas relapsed or refractory to doxorubicin and ifosfamide chemotherapy
MedDRA version: 9.1 Level: LLT Classification code 10039491 Term: Sarcoma

Intervention(s)

Product Code: CC-4047
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pomalidomide
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.0-

Product Code: CC-4047
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pomalidomide
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.0-

Product Code: CC-4047
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pomalidomide
CAS Number: 19171-19-8
Current Sponsor code: CC-4047
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-

Primary Outcome(s)

Main Objective: To evaluate the efficacy of CC-4047

Primary end point(s): Tumor response (Response Evaluation Criteria in Solid Tumors [RECIST])

Secondary Objective: To evaluate the safety of CC-4047

Secondary ID(s)

CC-4047-STSAR-001