EFFICACY AND SAFETY OF LANREOTIDE ATG 120 MG IN COMBINATION WITH TEMOZOLOMIDE IN SUBJECTS WITH PROGRESSIVE WELL DIFFERENTIATED THORACIC NEUROENDOCRINE TUMORS
- Conditions
- progressive well differentiated thoracic neuroendocrine tumorsMedDRA version: 20.0Level: PTClassification code 10007282Term: Carcinoid tumour pulmonarySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10062476Term: Neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10037342Term: Pulmonary carcinoid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10068115Term: Metastatic carcinoid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10068118Term: Metastatic carcinoid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10052399Term: Neuroendocrine tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10055108Term: Thymic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005579-10-IT
- Lead Sponsor
- IPSEN S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1)Provision of written Informed Consent prior to any study related procedures;
2)Adult subjects (male or female) = 18 years old ;
3)WHO Performance status = 2;
4)Histological documented unresectable advanced (locally or metastatic) well or moderately differentiated neuroendocrine tumors of the lung or thymus (typical and atypical carcinoids according to the WHO 2004 criteria);
5)Imaging documented progression within 12 months before screening visit (V1), according to RECIST criteria v 1.1;
6)Measurable disease, as defined by RECIST criteria v 1.1, on a CT scan performed at screening visit (V1);
7)Octreoscan or Ga68-DOTA-TATE/TOC/NOC-PET-TC within 12 months before screening visit (V1);
8)Adequate liver, renal and bone marrow function, as defined below:
a.Adequate bone marrow function
Absolute Neutrophil Count (ANC) = 1.5 × 109/L
Platelets = 100 × 109/L
Hemoglobin > 9 g/dL
b.Adequate liver function
Total serum bilirubin = 2.0 × ULN (exception for Gilbert disease)
International Normalized Ratio (INR) < 1.5
ALT and AST = 2.5 × ULN (= 5 × ULN, in subjects with liver metastases)
c.Adequate renal function
Serum creatinine = 1.5 × ULN
9)Willing and able to comply with study restrictions and willing to return to the clinic for the required visits during the study period and for the follow up evaluation as specified in the protocol.
10)Female subjects of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 6 months after participation in the study. Acceptable methods of contraception include double barrier method [i.e. condom and occlusive cap (diaphragm or cervical/vault caps)] with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
11)Male subjects with female partners of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 6 months after participation in the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1)History of hypersensitivity to the IMPs or drugs with a similar chemical structure or any excipient used in the formulation.
2)Any known contraindications to CT scan.
3)Poorly differentiated neuroendocrine carcinoma and mixed NET tumours, according to WHO 2004 criteria.
4)Neuroendocrine tumours other than lung or thymus.
5)Non-neuroendocrine thymic neoplasm.
6)Treated with systemic therapies (chemotherapy, interferon-alpha, somatostatin analogues, molecular target therapies) within 1 month prior to screening visit (V1).
7)Treated with a number of systemic therapy lines > 3 prior to screening visit (V1), and any of the following:
a. for chemotherapy no more than 1 line prior to V1;
b. for somatostatin analogue no more than 1 line therapy, considered as treatment lasting more than 6 months, prior to V1;
c. no therapy with TMZ prior to V1.
8)Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within 6 months prior to screening visit (V1).
9)Sign of recurrence of prior malignancies, or concomitant malignancies, or malignancies requiring active treatment within the last 3 years, other than the investigated disease, with the exception of previous basal cell skin cancer and previous cervical carcinoma in situ or neoplasm radically resected within 3 years prior to screening visit (V1).
10)Undergone major surgery/surgical therapy for any cause within 3 months prior to screening visit (V1).
11)Received external palliative radiotherapy within the last month prior to screening visit (V1).
12)Received locoregional therapies (TAE, TACE, TARF) and SIRT within 3 months prior to screening visit (V1).
13)Presence of symptomatic brain metastasis.
14)Unstable angina pectoris, symptomatic congestive heart failure (NYHA Class III or IV), serious uncontrolled cardiac arrhythmia or a history of myocardial infarction = 6 months prior to screening visit (V1).
15)Active or uncontrolled severe infection or known history of HIV seropositivity.
16)Previous Pneumocistis Carini Pneumonitis infection.
17)Liver cirrhosis, chronic active or persistent hepatitis, HCV and HBV positive test in presence of active disease clinical evidence.
18)Active bleeding diathesis, including abnormal coagulation (PT or APTT greater than 30% above ULN).
19)Uncontrolled diabetes mellitus as defined by HbA1c = 8%, despite adequate therapy. Subjects with history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary.
20)History of cholelithiasis or cholelithiasis found at screening visit (V1).
21)Any current or prior medical condition that may interfere with the conduct of the study.
22)Hypersensitivity to dacarbazine (DTIC).
23)Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
24)Treated with any other IMP within 1 month prior to screening visit (V1).
25)Likely to require treatment during the study with drugs that are not permitted by the study protocol.
26)Female subject pregnant or lactating. A pregnancy test will be performed at the start of the study for all female subjects of childbearing potential (i.e. not surgically sterile or 2 years postmenopausal).
27)Male subject who is planning a sperm donation during the entire study participation and at least 6 months after the last study drug administration.
28)History of, or known curr
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