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
Conditions
Interventions
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
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion 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
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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of CC-4047;Secondary Objective: To evaluate the safety of CC-4047;Primary end point(s): Tumor response (Response Evaluation Criteria in Solid Tumors [RECIST]) | — |
Countries
Austria
Outcome results
None listed