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<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ALLEVIATE A; BRIEF: The purpose of the study is to evaluate the safety & efficacy of Epratuzumab with standard treatments for patients with SLE. ; DRUG USED: Epratuzumab - SLE; DRUG CLASS: Biologic; INDICATION: Systemic Lupus Erythematosus (SLE); TARGET: Cluster of Differentiation 22 (CD22); THERAPY: Monotherapy; LEAD SPONSOR: UCB Pharma; CRITERIA: Inclusion Criteria: - Has SLE by ACR revised criteria (meets <4 criteria); - Has SLE with at least one elevated lupus antibody; - Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic Exclusion Criteria: - Active severe CNS or Renal disease defined by BILAG as Level A - Allergy to murine or human antibodies - Antiphospholid antibodies AND a history of thrombocytopenic events ; PRIMARY OUTCOME: Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks.; SECONDARY OUTCOME 1: Proportion of patients with complete response or partial response;[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ERA 223 - w/Abiraterone; BRIEF: To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine. ; DRUG USED: Xofigo; DRUG CLASS: New Molecular Entity (NME); INDICATION: Prostate Cancer; TARGET: DNA, Radiopharmaceutical, Tumor Cells; THERAPY: Combination; LEAD SPONSOR: Bayer; CRITERIA: Inclusion Criteria: - Histologically confirmed adenocarcinoma of the prostate - Male subjects of age ≥ 18 years - Prostate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 - Two or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis - Asymptomatic or mildly symptomatic prostate cancer - Subjects who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment - Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L) - Eastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1 Exclusion Criteria: - Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes, mitoxantrone and estramustine - Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone twice daily - Pathological finding consistent with small cell carcinoma of the prostate - History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations - History of or known brain metastasis - Malignant lymphadenopathy exceeding 3 cm in short-axis diameter - Blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization - Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered - Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime during the 4- week period prior to randomization. ; PRIMARY OUTCOME: Symptomatic Skeletal Event Free Survival (SSE-FS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ENRICH (2nd Line w/Irinotecan; JPN/KOR); BRIEF: This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer. ; DRUG USED: Nimotuzumab; DRUG CLASS: Biologic; INDICATION: Gastric Cancer; TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Combination; LEAD SPONSOR: Kuhnil Pharmaceutical Co., Ltd.; CRITERIA: Inclusion Criteria: 1. Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma. 2. Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent and platinum agent. 3. Subjects with EGFR overexpression (2+ or 3+ in IHC) Exclusion Criteria: 1. Subjects who have received irinotecan 2. Subjects who have received EGFR-directed therapy 3. Other active malignancy within the last 5 years ; PRIMARY OUTCOME: Overall Survival; SECONDARY OUTCOME 1: Progression Free Survival[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - ATTAIN (w/Brain Mets); BRIEF: This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient). ; DRUG USED: Onzeald; DRUG CLASS: New Molecular Entity (NME); INDICATION: Breast Cancer; TARGET: Topoisomerase I (Topo-I); THERAPY: Monotherapy; LEAD SPONSOR: Nektar Therapeutics; CRITERIA: Inclusion Criteria: - Female or male, age ≥ 18 years. - Histologically-confirmed carcinoma of the breast (either the primary or metastatic lesions) for whom single-agent cytotoxic chemotherapy is indicated. Patients may have either measurable or non-measurable disease according to RECIST version 1.1. - Patients must have a history of brain metastases that are non-progressing. - For triple-negative breast cancer, a minimum of 1 prior cytotoxic chemotherapy regimen must have been administered for the indication of metastatic disease.Depending on receptor status, 1 or 2 prior cytotoxic regimens are required prior to enrollment in this trial; hormonal and/or human epidermal growth factor receptor 2 (HER2) -targeted agents may be required. - Have had prior therapy (administered in the neoadjuvant, adjuvant, and/or metastatic setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be omitted if not medically appropriate or contraindicated for the patient). - Last dose of anticancer therapy must have been administered within 6 months of the date of randomization into this study. - All anticancer- and radiation therapy-related toxicities must be completely resolved or downgraded to Grade 1 or less (neuropathy may be Grade 2 or less). - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Demonstrate adequate organ function obtained within 14 days prior to randomization and analyzed by the central laboratory. - Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control throughout the duration of the study until 6 months following the last dose of study drug. - Males with female partners of child-bearing potential must agree to use a barrier contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository) throughout the duration of the study until 6 months following the last dose of study drug; in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 6 months following the last dose of study drug. Male patients should not donate sperm until 6 months following the last dose of study drug. Exclusion Criteria: - Last dose of anticancer therapy (including HER2-targeted therapy) within 14 days prior to randomization. - High-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic). - Major surgery within 28 days prior to randomization. - Concomitant use of any anticancer therapy or use of any investigational agent(s). - Received prior treatment for cancer with a camptothecin-derived agent. - Lesions on imaging, by cerebrospinal fluid or with neurological findings that are consistent with leptomeningeal disease or meningeal carcinomatosis. - Chronic or acute GI disorders resulting in diarrhea of any severity grade. - Patients who are pregnant or lactating, plan to get pregnant, or have a positive serum pregnancy test prior to randomization. - Enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days of randomization. - Hepatitis B or C, tuberculosis, or HIV. - Cirrhosis. - Prior malignancy (other than breast cancer) unless diagnosed and definitively treated more than 5 years prior to randomization. - Daily use of oxygen supplementation. - Significant known cardiovascular impairment. - Prior treatment with NKTR-102. - Psychiatric illness, social situation, or geographical situation that preclude informed consent or limit compliance. - Known intolerance or hypersensitivity to any of the products used in this study or their excipients. - For patients selecting vinorelbine or gemcitabine as the TPC agent, patients may not receive yellow fever vaccine in the 28 days prior to randomization. ; PRIMARY OUTCOME: Overall Survival (OS) of Patients; SECONDARY OUTCOME 1: Progression-Free Survival (Outside the Central Nervous System)[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - IMbrave251; BRIEF: This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination. ; DRUG USED: Tecentriq; DRUG CLASS: Biologic; INDICATION: Hepatocellular (Liver) Cancer (HCC) (Including Secondary Metastases); TARGET: Immune System, Programmed death-1 receptor (PD-1) / Programmed death ligands (PD-L1 and PD-L2); THERAPY: Combination; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/ cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic patients. - Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment shows either stable disease (SD), partial response (PR), or complete response (CR). - At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1. - Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 7 days prior to randomization - Child-Pugh class A within 7 days prior to randomization - Adequate hematologic and end-organ function Exclusion Criteria: - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. - History of leptomeningeal disease - History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC - History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death ; PRIMARY OUTCOME: Overall Survival (OS); SECONDARY OUTCOME 1: Progression Free Survival (PFS)[/INST]No</s> |
<s>[INST]<<SYS>>Predict if this trial will transition to the next phase. Return the answer as the corresponding label: Yes or No.<</SYS>>TRIAL NAME: Phase III - CURRENTS; BRIEF: This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression. ; DRUG USED: Tarceva; DRUG CLASS: New Molecular Entity (NME); INDICATION: Non-Small Cell Lung Cancer (NSCLC); TARGET: EGFR (Epidermal Growth Factor Receptor); THERAPY: Monotherapy; LEAD SPONSOR: Hoffmann-La Roche; CRITERIA: Inclusion Criteria: - Adult patients aged ≥18 years - inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC) - Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria - Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Life expectancy ≥12 weeks - Current cigarette smoker (having smoked >100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study Exclusion Criteria: - Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR) - Radiotherapy within 28 days prior to enrollment - Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed) ; PRIMARY OUTCOME: Progression-Free Survival (PFS); SECONDARY OUTCOME 1: Overall Survival (OS)[/INST]Yes</s> |