A randomized, open-label, multicenter, phase II study evaluating the efficacy and safety of BTH1677 (1,3–1,6 beta glucan; Imprime PGG) in combination with cetuximab and chemotherapy in patients with advanced non-small cell lung cancer

Investigational New Drugs

Volumn 35, Issue 3, 2017, Pages 345-358

  Thomas, M ^a   Sadjadian, P ^b   Kollmeier, J ^c   Lowe, J ^d   Mattson, P ^d   Trout, J R ^e   Gargano, M ^d   Patchen, M L ^d,f   Walsh, R ^d   Beliveau, M ^g   Marier, J F ^g   Bose, N ^d   Gorden, K ^d   Schneller, F ^h  

^a UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^b KLINIKUM MINDEN   (Germany)

^c HELIOS KLINIKUM EMIL VON BEHRING   (Germany)

^d Biothera   (United States)

^e Rutgers University   (United States)

^f Immuno Research Inc Inc   (United States)

^g Pharsight A Certara Company   (Canada)

^h TECHNICAL UNIVERSITY OF MUNICH   (Germany)

Author keywords

Beta glucan; Biomarker; Cetuximab; Immunotherapy; NSCLC

Indexed keywords

BETA(1,6) [POLY (1,3) GLUCOPYRANOSYL]POLY BETA (1,3) GLUCOPYRANOSE; BIOLOGICAL MARKER; CARBOPLATIN; CETUXIMAB; IMMUNOGLOBULIN G ANTIBODY; IMMUNOGLOBULIN M ANTIBODY; IMMUNOMODULATING AGENT; PACLITAXEL; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; BTH1677; GLUCAN;

ABDOMINAL PAIN; ACUTE HEART INFARCTION; ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANAPHYLAXIS; ANEMIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; BACKACHE; BLOOD TOXICITY; BONE PAIN; BRONCHOSPASM; CANCER CONTROL; CANCER PAIN; CANCER PATIENT; CANCER STAGING; CHILL; CONSTIPATION; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DERMATITIS; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; DYSGEUSIA; DYSPHONIA; DYSPNEA; ENZYME LINKED IMMUNOSORBENT ASSAY; EPISTAXIS; FATIGUE; FEMALE; FEVER; GASTROINTESTINAL SYMPTOM; GERMANY; HEADACHE; HEART ATRIUM FLUTTER; HEART FAILURE; HEMOGLOBINOPATHY; HEMOPTYSIS; HUMAN; HYPERSENSITIVITY; HYPOKALEMIA; HYPOMAGNESEMIA; INSOMNIA; LEUKOCYTE COUNT; LEUKOPENIA; LIMB PAIN; LOADING DRUG DOSE; LUNG EMBOLISM; LUNG HEMORRHAGE; LYMPHATIC SYSTEM DISEASE; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MEDICAL PARAMETERS; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; NON SMALL CELL LUNG CANCER; OPEN STUDY; OROPHARYNX PAIN; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PARESTHESIA; PARONYCHIA; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; POLYNEUROPATHY; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; RHINOPHARYNGITIS; SENSORY NEUROPATHY; SIDE EFFECT; SKIN FISSURE; SKIN TOXICITY; STOMATITIS; SURVIVAL TIME; TACHYCARDIA; THORAX PAIN; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TIME TO PROGRESSION; TREATMENT DURATION; TREATMENT RESPONSE; UNITED STATES; VOMITING; BLOOD; CLINICAL TRIAL; KAPLAN MEIER METHOD; LUNG TUMOR; METABOLISM; MIDDLE AGED; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; CETUXIMAB; FEMALE; GLUCANS; HUMANS; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MIDDLE AGED; PACLITAXEL; TREATMENT OUTCOME;

EID: 85015656064     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-017-0450-3     Document Type: Article

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