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A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks (Q3W) in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy.

The purpose of this study is to evaluate the safety of darbepoetin alfa, inclusive of the effects on survival and cancer progression, and the necessity of blood transfusions.

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Cancer-Related Pain, Followed by an Open-Label Extension Phase

The objective of this study is to evaluate the safe use of JNJ-42160443 compared to placebo and to demonstrate whether patients JNJ-42160443 will, in addition to their standard treatment for pain, more pain relief than more patients receiving…

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Single Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Effect of Food on Pharmacokinetics of CAL-120 in Healthy Male Subjects

Primary:to evaluate the safety and tolerability of single dose administration of the study drug in healthy male subjectsto determine the pharmacokinetic parameters following single dose administration of the study drug in healthy male subjectso…

A randomized, double-blind placebo- and active-controlled study of the pharmacokinetics, pharmacodynamics and safety of single ascending doses of HM10660A (LAPS-Interferon Alpha-2B) in healthy male subjects

to study the safety and tolerability of HM10660A (LAPS-interferon alpha-2b), including immunogenicity, as compared to Pegasys® (PEG-interferon alpha-2a)to study the pharmacokinetics and pharmacodynamics of HM10660A (LAPS interferon alpha-2b) as…

Prospective, randomized, pharmacological intervention study; evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan versus placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab

Primary objectives:1) To determine whether concurrent ATII-antagonist treatment can prevent trastuzumab-related cardiotoxicity, defined as a decline in LVEF of more than 15% or a decrease to an absolute value <45%Secondary objectives:1) To…

A confirmatory, placebo-controlled, randomised, double-blind, single-dummy, parallel group, ratio-finding study in constipated pain patients to establish an optimal hydromorphone â¤* naloxone ratio with an improved bowel function and a comparable analgesic efficacy compared to hydromorphone alone

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A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC)

This study will evaluate the antitumor activity of RAD001 versus placebo in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).

Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer - Cachexia (NSCLC-C): An Extension Study;(ROMANA-3)

Based on the data available, Anamorelin HCl produces an increase in total body weight and Lean Body Mass in patients with advanced cancer, and specifically in patients with NSCLC, in addition to increasing muscle strength and improving quality of…

Anamorelin HCl in the Treatment of
Non-Small Cell Lung Cancer - Cachexia (NSCLC-C):
A Randomized, Double-Blind, Placebo-Controlled,
Multicenter, Phase III Study to Evaluate the
Safety and Efficacy of Anamorelin HCl
in Patients with NSCLC-C

Based on the data available, Anamorelin HCl produces an increase in total body weight and Lean Body Mass in patients with advanced cancer, and specifically in patients with NSCLC, in addition to increasing muscle strength and improving quality of…

A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

This study will evaluate the antitumor activity of RAD001 versus placebo in patients with angiomyolipoma associated with either TSC or LAM.

Phase III Randomized Double-blind Cross-over trial of Supersaturated Calcium-phosphate rinse (Caphosol®) versus NaCl 0.9% in the relief of Oral Mucositis in patients receiving Targeted Therapy

To assess the effect of Caphosol® oral rinse on clinical outcomes of selected oral symptom burden (oral mucositis/stomatitis (aphthous-like), oral pain, taste change (dysgeusia), difficulty swallowing (dysphagia), difficulty oral intake, and dry…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of PEGylated Recombinant Human Hyaluronidase (PEGPH20) in Combination With nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus nab-Paclitaxel and Gemcitabine in Subjects with Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Primary objective is: * To determine the overall survival (OS) benefit of PAG treatment, compared with AG treatment, in subjects with HA-high Stage IV previously untreated PDA.Secundary objectives are:* To determine the PFS benefit of PAG treatment…

A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC).

The primary objective of the study is to assess the incidence of pathological complete response (pCR) in breast and ipsilateral axillary tissue after daily treatment with veliparib in combination with neoadjuvant carboplatin and paclitaxel followed…

A phase 1 randomized, double-blind, placebo-controlled, maximum tolerated dose escalation, safety, tolerability and pharmacokinetic adaptive study of RAD1901 administered to healthy postmenopausal women

The purpose of the study is to investigate to what extent RAD1901 is tolerated.It will also be investigated how quickly and to what extent RAD1901 is absorbed and eliminated from the body.In addition, in Group 6 it will be investigated to what…

A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF AVELUMAB IN COMBINATION WITH STANDARD OF CARE CHEMORADIOTHERAPY (CISPLATIN PLUS DEFINITIVE RADIATION THERAPY) VERSUS STANDARD OF CARE CHEMORADIOTHERAPY IN THE FRONT LINE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

To demonstrate that treatment with avelumab in combination with standard of care (SOC) CRT is superior to SOC CRT alone in prolonging progression-free survival (PFS) in front-line patients with high-risk (as defined in Inclusion Criterion 2),…

Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer
(HER2CLIMB-02)

This study has been transitioned to CTIS with ID 2024-514733-38-00 check the CTIS register for the current data. Primary* Compare progression-free survival (PFS) by investigator assessment per Response Evaluation Criteria inSolid Tumors (RECIST) v1.…

DAVINCY trial: optimal Duration of (fos)aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in children: a double-blind placebo-controlled crossover randomized phase III trial*

This study has been transitioned to CTIS with ID 2024-517846-32-00 check the CTIS register for the current data. To evaluate the effect of prolonged duration of (fos)aprepitant prophylaxis on the prevention of delayed CINV (complete remission in the…

Erector spinae plane block for post-operative analgesia management following video-assisted thoracoscopic surgery

This study aims to test the hypothesis that ultrasound guided ESPB compared to patient controlled analgesia with Morphine, after a VATS lobectomy of wedge excision, reduces acute post-operative pain and opioid consumption. Our secondary aims are to…

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-DOSE ESCALATION, MULTIPLE-DOSE ESCALATION, AND FOOD EFFECT STUDY OF FLX475 IN HEALTHY MALE AND FEMALE SUBJECTS

The purpose of this study is to investigate how safe the new compound FLX475 is when it is administered to healthy subjects. FLX475 has not been administered to humans before. It has been previously tested in the laboratory and on animals. FLX475…

First-in-human phase I safety, pharmacokinetic, and pharmacodynamic study of G1T28-1 in healthy male and female subjects.

The purpose of the study is to investigate to what extent G1T28-1 is tolerated. It will also be investigated how quickly and to what extent G1T28-1 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, a possible…