AN EARLY PHASE CLINICAL STUDY AT SEVERAL RESEARCH CENTERS TO EXPLORE THE SAFETY, BLOOD LEVELS AND ANTITUMOR EFFECTS USING DIFFERENT DOSES OF CC-115 TAKEN BY MOUTH FOR PATIENTS WITH ADVANCED SOLID CANCER OR EITHER NON-HODGKIN LYMPHOMA OR MULTIPLE MYELOMA.
- Conditions
- Subjects with advanced solid tumors, non-hodgkin lymphoma (NHL) and multiple myeloma (MM).MedDRA version: 14.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004558-24-ES
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 118
Please refer to protocol section 7.2 for the complete inclusion criteria, which are summarized below.
?Men and women, 18 years or older, with histological or cytological confirmation of advanced unresectable solid tumors, non-hodgkin?s lymphoma (NHL), or multiple myeloma (MM), including those who have progressed on (or not been able to tolerate) standard anticancer therapy or for whom no other conventional therapy exists. Ewing?s sarcoma (ES) subjects may be 12 years or older.
?Consent to screening tumor biopsy (Part A optional; Part B mandatory except as specified for individual tumor types)
?ECOG PS 0 or 1
?Laboratory values: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; hemoglobin (Hgb) >= 9 g/dl; platelets >= 100 x 10^9/L; potassium within normal range or correctable with supplements; AST/SGOT and ALT/SGPT <= 2.5 x ULN or <= 5.0 x ULN if liver tumor is present; serum total bilirubin <= 1.5 x ULN; serum creatinine <= 1.5 x ULN or 24-hr clearance >= 50 mL/min; negative serum or urine pregnancy test within 72 hrs before starting study treatment in females of childbearing potential
Dose expansion part (Part B) of the protocol only:
?Consent to retrieve formalin-fixed, paraffin-embedded (FFPE) archival tumor tissue; an exemption waiver may be granted by the Sponsor in exceptional circumstances.
?Histologically-confirmed tumors of the following types. Please refer to the specific inclusion criteria applicable to each tumor type, described in protocol section 7.2, which are in addition to, or supersede, the above criteria where applicable:
-Glioblastoma multiforme (GBM) or gliosarcoma, excluding WHO Grade IV oligoastrocytoma
-Head & neck squamous cell cancer (HNSCC)
-Triple negative breast cancer (TNBC)
-Hormone receptor-positive breast cancer (HRPBC)
-Castration-resistant prostate cancer (CRPC)
-Ewings Family of Sarcomas
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
Please refer to protocol section 7.2 for the complete exclusion criteria, which are summarized below.
?Symptomatic central nervous system metastases
?Known acute or chronic pancreatitis
?Any peripheral neuropathy >= NCI CTCAE grade 2
?Persistent diarrhea or malabsorption >= NCI CTCAE grade 2, despite medical management. Impaired ability to swallow
?Impaired cardiac function or clinically significant cardiac diseases, including any of the following: LVEF < 45% as determined by MUGA scan or ECHO; complete left bundle branch, or bifasicular, block; congenital long QT syndrome; persistent or history of clinically meaningful ventricular arrhythmias or atrial fibrillation; QTcF > 460 msec on screening ECG (mean of triplicate recordings); unstable angina pectoris or myocardial infarction <= 3 months prior to starting CC-115; other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure >= 160/95 mmHg)
?Diabetes mellitus on active treatment, or subjects with either fasting blood glucose (FBG) >= 126 mg/dL (7.0 mmol/L), or HbA1c >= 6.5%
?Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
?Prior systemic cancer-directed treatments or investigational modalities <= 5 half lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy
?Major surgery <= 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
?Pregnancy or breast feeding
?Adults of reproductive potential not employing two forms of birth control (defined in protocol section 7.2):
?Known HIV infection
?Known chronic hepatitis B or C virus (HBV/HCV) infection, unless this is comorbidity in subjects with HCC
?Concurrent active second malignancy for which the subject is receiving therapy, excluding non-melanomatous skin cancer or carcinoma in situ of the cervix
Dose expansion part (Part B) of the protocol only:
?Prior treatment with agents targeting both mTOR complexes (dual TORC1+TORC2 inhibitors) and/or PI3K/AKT pathways. However, prior treatment with isolated TORC1 inhibitors (e.g., rapalogs) is allowed in both parts of this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method