Cancer of Unknown Primary Site MedDRA version: 20.0 Level: LLT Classification code 10032248 Term: Other malignant neoplasm of unspecified site System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Alecensa
Product Name: Alectinib
Product Code: RO5424802/F03, RO5424802/F16
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ALECTINIB
Current Sponsor code: RO5424802
Other descript
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >=18 years - Histologically-confirmed unresectable poor-risk or unfavorable prognosis subset of CUP as defined by European Society for Medical Oncology 2015 clinical practice guidelines for CUP - At least one lesion that is measurable according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) - Availability of a tumor Formalin-fixed paraffin-embedded (FFPE) block =12 weeks - Eligible for platinum-based chemotherapy - Adequate hematologic and end-organ function - Agrees to use protocol defined methods of contraception 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 190 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 600
Exclusion criteria
Exclusion criteria: - Squamous cell CUP - Patients with histology and immunohistology profiles (per 2015 ESMO guidelines) that are not adenocarcinoma or poorly differentiated carcinoma / adenocarcinoma, i.e., non-epithelial cancer, extragonadal germ-cell tumor, neuroendocrine tumors, sarcoma, melanoma, mesothelioma, hematologic malignancies (list is not limitative) - Patient with an immunohistochemistry profile that provides a definitive clinical indication of a primary cancer with a specific treatment - Patients who can be assigned to a specific subset of CUP for which a specific treatment is recommended by the 2015 ESMO Clinical Practice Guidelines for CUP or with a clinical and IHC profile indicative of a specific primary tumor are also excluded. These are: Poorly differentiated carcinoma with midline distribution, women with papillary adenocarcinoma of the peritoneal cavity, women with adenocarcinoma involving only the axillary lymph nodes, squamous cell carcinoma of the cervical lymph nodes, poorly differentiated neuroendocrine tumors, men with blastic bone metastases and elevated prostate-specific antigen, patients with a single, small, potentially resectable tumor, colon cancer-type CUP (with a CK7 negative, CK20 positive, CDX-2 positive immunohistochemistry profile), CK7 positive, CK20 negative and TTF-1 positive tumors in a context suggestive of lung adenocarcinoma or thyroid cancer, IHC profile definitely indicative of breast cancer OR an IHC profile indicative of breast cancer and either a history of breast cancer or lymph nodes in the drainage areas of the breast, high-grade serious carcinoma histology and elevated CA125 tumor marker and/or a mass in the gynecological tract or any tumor mass or lymph node in the abdominal cavity, IHC profile suggestive of renal cell carcinoma and renal lesions, with a Bosniak classification higher than IIF, IHC profile compatible with cholangiocarcinoma or pancreatobiliary and 1 or 2 liver lesions without extrahepatic disease or with only pulmonary metastases and/or lymph nodes in the drainage areas of the liver - Known presence of brain or spinal cord metastasis, as determined by CT or magnetic resonance imaging evaluation during screening - History or known presence of leptomeningeal disease - Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current alcohol abuse, or cirrhosis - Human immunodeficiency virus infection - Positive for hepatitis C virus antibody at screening. If a patient has a positive HCV antibody test at screening, an HCV RNA test must also be performed. A patient will be excluded from the study only if the HCV antibody and the HCV RNA test are positive. If the HCV antibody test is positive, but the HCV RNA test is negative, the patient may enroll in the study - Positive for hepatitis B surface antigen (HBsAg) at screening. If HBsAg test is negative but the total hepatitis B core antibody test (HBcAb) is positive, hepatitis B virus DNA must be performed and if the resulting HBV DNA test is positive, the patient will be excluded from the study - Active tuberculosis at screening - Active infections requiring intravenous antibiotics - Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina - History of malignancy within 5 years prior to initiation of study treatment with the exception of th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of molecularly-guided therapy versus platinum-based chemotherapy in terms of Progression free survival in patients with CUP whose best response to 3 cycles of platinum induction chemotherapy was assessed complete response(CR), partial response(PR) or stable disease(SD);Secondary Objective: ?To evaluate the efficacy of molecularly-guided therapy versus platinum-based chemotherapy in terms of objective survival, overall response rate, duration of response and disease control rate in patients with CUP whose best response to 3 cycles of platinum induction chemotherapy was assessed CR, PR or SD ?To evaluate the safety of molecularly-guided therapy or chemotherapy in all patients in the study who receive targeted therapy or cancer immunotherapy ;Primary end point(s): 1. Progression-free survival;Timepoint(s) of evaluation of this end point: 1. Up to 68 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall survival 2. Objective response rate 3. Duration of response 4. Disease control rate 5. Incidence, nature and severity of adverse events (AEs), with severity determined according to NCI CTCAE v5.0 6. Incidence and reasons for any dose reductions, interruptions, or premature discontinuation of any component of study treatment 7. Change from baseline in targeted vital signs 8. Incidence in clinical abnormalities;Timepoint(s) of evaluation of this end point: 1-8. Up to 68 months | — |
Countries
Australia, Austria, Brazil, Bulgaria, Chile, Colombia, Croatia, Cyprus, Czechia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Republic of, Latvia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Spain, Switzerland, Thailand, Turkey, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed