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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,…

Multi-arm, Non-randomized, Open-Label Phase IB Study to Evaluate GSK3052230 in Combination with Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects with Solid Malignancies and Deregulated FGF Pathway Signaling (FGF117360)

Primary: to characterize the safety and tolerability of GSK3052230 in combination with chemotherapy regimens, to determine the MTD and to assess overall response rate in patients with stage IV or recurrent squamous NSCLC with FGFR1 gene…

A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) versus Paclitaxel, Docetaxel or Vinflunine in Subjects with Recurrent or Progressive Metastatic Urothelial Cancer

Primary Objectives(1) To evaluate the overall survival (OS) of subjects with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy (recurrent/progressive metastatic…

A multi-institutional open label, trial evaluating the efficacy of Gemcitabine and Docetaxel in patients with relapsed or refractory metastatic colorectal adenocarcinoma with methylated CHFR and/or microsatellite instability (MSI) phenotype.

Determine the efficacy of combination gemcitabine and docetaxel chemotherapy in the treatment of metastatic colorectal cancer with CHFR and/or MSI phenotype

A Phase III Randomized Trial of MK-3475 (Pembrolizumab) versus Standard Treatment in Subjects with Recurrent or Metastatic Head and Neck Cancer

Primary Objectives:(1) Objective: To compare the overall survival (OS) in subjects with R/M HNSCC treated with pembrolizumab compared to standard treatment.Secondary Objectives:PD-L1 Positive Population:(1) Objective: To compare Overall Survival (OS…

Phase II Study of Docetaxel, Oxaliplatin, Capecitabine with Bevacizumab and Trastuzumab in case of human epidermal growth factor receptor 2 (HER2)-positivity in Patients with Locally Advanced or Metastatic Gastric Cancer or Adenocarcinoma of the Gastro-oesophageal Junction (B-DOCT study)

Primary: Progression free survival.Secondary: Toxicity, overall survival, response rate, duration of response, translational research.

A multicenter, open-label, randomized phase II study to evaluate the efficacy of AUY922 vs pemetrexed or docetaxel in NSCLC patients with EGFR mutations who have progressed on prior EGFR TKI treatment (CAUY922A2207)

Primary: Progression Free Survival (PFS) in patients treated with AUY922 versus pemetrexed or docetaxel.Secondary: Overall response rate, disease control rate, overall survival, safety and tolerability, PK.

Lean Body Mass as a determinant of docetaxel pharmacokinetics and toxicity (LEANDOC)

Primary objective:To determine which anthropometric parameters, LBM, total body weight (TBW) or BSA correlates best to docetaxel exposure (AUC). Secondary objectives:To determine if occurrence of docetaxel toxicity can be related to dose/LBM.To…

High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency

This study will investigate whether oligometastatic triple negative or BRCA1/2 related breast cancer can be treated effectively with a multimodality approach including induction chemotherapy, and whether high dose alkylating chemotherapy can improve…

A randomized phase II trial of docetaxel plus carboplatin versus docetaxel in hormone refractory prostate cancer patients who have progressed after response to prior docetaxel chemotherapy: RECARDO STUDY

Primary objectives:* Progression-free survival (PFS) defined as either of the following occurrences, whichever comes first:o PSA progression o Progressive disease according to RECIST when measurable diseaseSecondary objectives:* Toxicity profile.*…

A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxoterere* (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA.

To evaluate and compare progression free survival (PSA) between the two treatment arms.

Mass balance of docetaxel after administration of Oral Docetaxel in combination with Ritonavir

The primary objective of this study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism and excretion) of docetaxel (as ModraDoc003 10mg tablets) after administration of a single dose of oral docetaxel in…

Phase III randomized trial with neoadjuvant chemotherapy (TAC) with or without zoledronic acid for patients with large resectable or locally advanced HER2-negative breast cancer.

In this study we want to investigate whether the submission of zoledronic acid to neoadjuvant chemotherapy benefits the pathological complete response, and thus favors a better clinical outcome in patients with large ressectable or locally advanced…

A randomized, open-label, multi-center phase II study to compare AUY922 with docetaxel or irinotecan in adult patients with advanced gastric cancer, who have progressed after one line of chemotherapy

Primary objective: * To assess the treatment effect on progression-free survival in patients who receive AUY922 on a once-weekly schedule versus patients who receive docetaxel or irinotecanSecondary Objectives* To estimate the overall survival…

Weekly administration of (bi-)daily Oral Docetaxel in combination with Ritonavir

The primary objective is to determine the maximum tolerated dose (MTD) of docetaxel (as ModraDoc001) that can safely be administered to patients with cancer in a bi-daily weekly schedule.

Phase I interaction study of Docetaxel and Tolbutamide with supplementation of Milk Thistle

Primary objective: To determine pharmacokinetic interactions between milk thistle and docetaxel and between milk thistle and tolbutamide in patients with cancer.Secundary objective: To determine the safety of the use of milk thistle in combination…

A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared with Docetaxel in 2nd Line Subjects with Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Nonsmall Cell Lung Cancer (MEK114653)

Primary: progression-free survival in the GSK1120212-group in comparison with the docetaxel group. Secondary: safety and tolerability, response rate, duration of response, overall survival, PK.

An Open-label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

Primary ObjectiveTo compare the objective response rate and overall surival of BMS-936558 versus docetaxel in subjects with squamous cell NSCLC after failure of prior platinum-based chemotherapySecondary ObjectivesTo compare the progression-free…

Absorption and excretion of docetaxel (as ModraDoc 005 tablets) after oral administration in combination with ritonavir.

To quantitatively determine the absorption and excretion of docetaxel (as ModraDoc005 10 mg tablets) after administration of a single low dose and a single high dose of oral docetaxel in combination with ritonavir.

A randomized phase III trial of erlotinib versus docetaxel in patients with advanced squamous cell non-small cell lung cancer who failed first line platinum based doublet chemotherapy stratified by VeriStrat Good vs VeriStrat Poor (EMPHASIS, NVALT13, ETOP 3-12)

Primary: Explore the predictive ability of the VeriStrat signature, by testing for interaction between treatment arms (Arm A: erlotinib vs Arm B: docetaxel) and VeriStrat status (VSG vs VSP) using as outcome progression free survival. Secondary…