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TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral
Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic
Chemotherapy in Patients with Mutant EGFR Non-small Cell Lung Cancer
(NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase
Inhibitor (TKI) and Platinum-doublet Chemotherapy

Primary Objective• To compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the progression-free survival (PFS), with that of single-agent cytotoxic chemotherapy in patients with EGFR mutated,…

Phase II trial of the combination of gemcitabine and 131I-MIBG therapy in paediatric patients with relapsed or progressive neuroblastoma

To evaluate the efficacy and toxicity of gemcitabine in combination wth 131I-MIBG in pediatric patients with relapsed or progressive neuroblastoma.

A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator*s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Primary:* To determine if alisertib improves overall response rate (ORR; complete response [CR] plus partial response [PR]) versus a selection of single agents in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)* To determine…

A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator*s Choice in Subjects with Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

The primary objective of this study is to determine the efficacy of administration of aldoxorubicin compared to investigator*s choice of treatment in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have relapsed…

PeRsOnalized treatment fOr patients with pleural eFfusions due to malignant pleural mesothelioma or lung cancer in second or third line. An open label phase II study (Acronym: the PROOF study)

The aim of this study is to evaluate the efficacy of a personalized drug profiling method using short-term cultures of malignant cells derived from the patient*s pleural fluid.

A phase II, randomized, placebo controlled study to evaluate the efficacy of the combination of gemcitabine, erlotinib and metformin in patients with locally advanced and metastastatic pancreatic cancer

In this study we want to determine the activity and safety of concurrent interruption of the MAPK and PI3K pathways by the EGFR tyrosine kinase inhibitor erlotinb and metformin, combined with gemcitabine in patients with metatastatic pancreatic…

Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects with Previously Untreated Stage IV Squamous Non Small Cell Lung Cancer (NSCLC)

The purpose of this study is to find out if the combination of gemcitabine plus carboplatin and iniparib works better than gemcitabine and carboplatin alone in subjects with stage IV squamous non-small-cell lung cancer (NSCLC) that have not…

PHASE I-II STUDY OF GEMCITABINE AND VALPROIC ACID PLUS VALGANCICLOVIR IN PATIENTS WITH ADVANCED NASOPHARYNGEAL CARCINOMA

Primary:The primary objective is to determine the safety and tolerability of the combination treatment, i.e. GCb, VPA and GCV, by evaluation of adverse events (AE*s) serious adverse events (SAE*s) and all clinically significant changes in clinical…

A Phase III, Open-label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination with Tremelimumab, Determined by PD-L1 Expression, Versus Standard of Care in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB IV) who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC)

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 versus Standard of Care in NSCLC patients with PD-L1-positive tumours and the combination of MEDI4736 plus tremelimumab (MEDI4736+…

Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer: a multicentre randomized phase III clinical trial

Primary objectiveTo investigate whether the addition of preoperative radiochemotherapy to the standard treatment, consisting of explorative laparotomy, pancraticoduodenectomy if possible, followed by adjuvant chemotherapy, improves the overall…

An open label, dose escalation followed by dose expansion, safety and tolerability trial of CAN04, a fully humanized monoclonal antibody against IL1RAP, in subjects with solid malignant tumors.

Primary ObjectivesPart I- To define the Maximum Tolerated Dose (MTD) or Recommended Phase 2 dose (RP2D) of CAN04 once weekly (Q1W) in subjects with relapsed or refractory NSCLC, PDAC, TNBC or CRC.Part II- To determine the safety and tolerability of…

A Phase III, Open Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination with Celecoxib and Gemcitabine in Patients with Malignant Pleural Mesothelioma

The primary objective of this study is to compare the overall survival (OS) associated with rAd-IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM…

A Phase III, open-label, multicenter trial of avelumab (MSB0010718C) versus platinum-based doublet as a first-line treatment of recurrent or Stage IV PD-L1+ non*small-cell lung cancer

To demonstrate superiority with regard to Progression Free Survival based on an Independent Review Committeeassessment of avelumab versus platinum-based doublet in NSCLC subjects with PD-L1+

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma (KEYNOTE 966)

This study has been transitioned to CTIS with ID 2023-506657-38-00 check the CTIS register for the current data. To compare pembrolizumab plus gemcitabine plus cisplatin to placebo plus gemcitabine plus cisplatin with respect to overall survival (OS…

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

This study has been transitioned to CTIS with ID 2024-513513-12-00 check the CTIS register for the current data. Primary ObjectivesEvaluate the efficacy of pemigatinib versus gemcitabine plus cisplatin in the first-line treatment of participants…

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens

Primary Objective:• To assess and compare efficacy of sacituzumab govitecan to TPC as measured by progression free survival (PFS) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1…

Neo-adjuvant versus Adjuvant chemotherapy in Upper Tract Urothelial Carcinoma: A feasibility phase II randomized clinical trial (*URANUS*)

This study has been transitioned to CTIS with ID 2024-514991-41-01 check the CTIS register for the current data. To assess the proportion of UTUC patients with adequate renal function and fit to receive either neo- or adjuvant cisplatin-based…

A Phase III Study of BBI-608 plus nab-Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma.

To compare overall survival (OS) of patients with metastatic (Stage IV) PDAC treated with BBI-608 plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine.

Switch maintenance treatment with gemcitabine for patients with malignant mesothelioma who do not progress after 1st line therapy with a pemetrexed-platinum combination. A randomised open label phase II study. ;NVALT 19

Primary objectives:1. Determine the potential improvement of the duration of progression-free survival by maintenance treatment with gemcitabine. Secondary objectives:1. To compare the objective radiological response (ORR) rate2. To compare overall…

An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M4344 (formerly VX-803) as a Single Agent and in Combination With Cytotoxic Chemotherapy in
Participants With Advanced Solid Tumors

Primary Objective part A:* To evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered BIW in subjects withadvanced solid tumors* To determine the MTD and/or RP2D of single-agent M4344 administered BIW in…