Part 1: Advanced, treatment-refractory solid tumors Part 2: Advanced non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, ovarian cancer, or sarcoma. ------------------------------------------------------------ Parte 1:tumores sólidos refractarios y avanzados. Parte 2:Cáncer de pulmón no microcítico avanzado (CPNM), cáncer colorrectal (CRC), cáncer pancreático, cáncer de ovario o sarcoma. MedDRA version: 9.1 Level: LLT Classification code 10061451 Term: Colorectal ca
Conditions
Interventions
Product Name: AMG 655
Product Code: AMG 655
Pharmaceutical Form: Intravenous infusion
Current Sponsor code: AMG 655
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease Related - Part 1: Histologically or cytologically confirmed, locally advanced or metastatic, treatment-refractory solid tumors - Part 2: Histologically or cytologically confirmed, locally advanced or metastatic - NSCLC (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens) - CRC (up to 2 prior treatment regimens) - Pancreatic cancer (up to 1 prior treatment regimen) - Ovarian cancer (up to 2 prior treatment regimens), or - Sarcoma (up to 2 prior treatment regimens) - according to cohort availability - Part 2: Measurable disease according to modified RECIST (at least 1 measurable lesion) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix G) - Life expectancy ≥ 3 months Demographic. - Women or men ≥ 16 years of age Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained (Section 12.1) Laboratory Within 7 days before enrollment, the following test results must be obtained: - Hematological function, as follows: - Hemoglobin ≥ 9 g/dL - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Platelet count ≥ 100 x 109/L (without transfusion ≤ 14 days prior to enrollment) - Renal function, as follows: - Serum creatinine ≤ 2 x ULN - Hepatic function, as follows: - Aspartate aminotransferase (AST; SGOT) ≤ 2.5 x ULN ( 5 x ULN if attributable to liver metastases) - Alanine aminotransferase (ALT; SGPT) ≤ 2.5 x ULN (≤ 5 x ULN if attributable to liver metastases) - Total Bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with UGT1A1 promoter polymorphism ie, Gilbert syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to enrollment) - Coagulation: - Partial thromboplastin time (PTT) ≤ 1.3 x ULN - International normalized ratio (INR) ≤ 1.5, - Amylase ≤ 2 x ULN - Lipase ≤ 2 x ULN - Adequate glycemic function, for subjects with known diabetes (Type 1 or 2), as follows: - Must be controlled with a glycosylated hemoglobin (HgbA1c) of ≤ 8.0% - Documented fasting blood sugars ≤ 160 mg/dL. Diabetic subjects who have recently had their glycemic control regimens adjusted and have documented fasting blood glucose concentrations ≤ 160 mg/dL may be considered regardless of HgbA1c value, if per investigator discretion they are considered to have adequate glycemic function - Negative pregnancy test within 3 days prior to enrollment (females of child-bearing potential only) General - Plan to begin protocol specific therapy ≤ 7 days after enrollment Are the trial subjects under 18? yes 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: Disease Related - Presence of uncontrolled central nervous system (CNS) disease: - Subjects with CNS metastases that are both definitively treated and stably controlled are eligible if all of the following apply: (1) definitive therapy has been administered (surgery and/or radiation therapy); (2) there is no additional treatment planned for brain metastases; (3) the subject is clinically stable; and (4) the subject is off corticosteroids or on a stable dose of corticosteroids for at least 14 days prior to enrollment. - Part 2: Any prior or synchronous other malignancy, except: - Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and considered to be at low risk for recurrence by the treating physician - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease - Adequately treated cervical carcinoma in situ without evidence of disease - Prostatic intraepithelial neoplasia without evidence of prostate cancer Cancer Therapy - Systemic chemotherapy, hormonal therapy, immunotherapy, experimental or approved anticancer proteins/antibodies therapy ≤ 28 days before enrollment, except: - In Part 1, patients may continue approved hormonal therapy as medically indicated - Unresolved toxicity(ies) from prior anti-cancer therapy, which may increase the risks associated with study participation - Prior treatment with death receptor agonists (including but not limited to rhApo2L/TRAIL [AMG 951], apomab, mapatumumab, lexatumumab, CS-1008) - Prior treatment with IGF receptor antagonists (including but not limited to CP-751,871, MK0646, AVE1642 or IMC-A12) - Patients may not have received prior radiotherapy to > 25% of the bone marrow. Radiation must have been concluded ≥ 14 days prior to enrollment. Patients must have recovered from all potential side effects and must be clinically stable. Medications/ Treatments - Therapeutic anticoagulation treatment within 7 days prior to enrollment. - Prophylactic anticoagulation of venous access devices (eg, with low-dose coumadin [1-2 mg/day] or low-dose heparin) is allowed, provided PTT and INR eligibility criteria are met. - Recent infection requiring systemic anti-infective treatment that was completed - 14 days before enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection) Medical Conditions - Major surgical procedure ≤ 28 days before enrollment, or not yet recovered from prior major surgery - Minor surgical procedure (eg, open biopsy) ≤ 7 days before enrollment, or not yet recovered from prior minor surgery. Note: uncomplicated placement of vascular access device, fine needle aspiration, thoracocentesis or paracentesis ≥ 3 days prior to enrollment is acceptable - History of bleeding diathesis - Pulmonary embolism or arterial/venous thromboembolism within 6 months - Known positive test for human immunodeficiency virus, hepatitis C virus or acute or chronic hepatitis B infection - Any clinically significant medical or psychiatric condition, co-morbid disease, addictive disorder, or laboratory abnormality (eg, cardiovascular disease or chronic obstructive pulmonary disease), which may increase the risks associated with study participation or study treatments or could interfere with the safe delivery of study treatment or increase risk of toxicity - Subject has any kind of disorder that compromises the ability of the subject to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as DLT Part 2: ORR (confirmed CR and PR, by modified RECIST);Main Objective: Part 1: To identify a dose of AMG 655 in combination with AMG 479 that is safe and tolerated as determined by the incidence of dose limiting toxicity (DLT). Part 2: To estimate the efficacy, as measured by the objective response rate (ORR; confirmed complete response [CR] and partial response [PR] using modified Response Evaluation Criteria in Solid Tumors [RECIST]) of AMG 655 in combination with AMG 479.;Secondary Objective: Part 1: - To evaluate the safety and tolerability of AMG 655 in combination with AMG 479. - To evaluate anti-AMG 655 antibody formation and anti-AMG 479 antibody formation. - To evaluate the pharmacokinetics (PK) of AMG 655 and of AMG 479. Part 2: - To estimate the efficacy of AMG 655 in combination with AMG 479, as measured by time to response, duration of response, and progression-free survival (PFS). - To evaluate the safety and tolerability of AMG 655 in combination with AMG 479. - To evaluate anti-AMG 655 antibody formation and anti-AMG 479 antibody formation. - To evaluate the PK of AMG 655 and of AMG 479. | — |
Countries
Spain
Outcome results
None listed