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NCT ID: NCT03816839 Active, not recruiting - Breast Cancer Clinical Trials

Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)

AMEERA-2
Start date: March 25, 2019
Phase: Phase 1
Study type: Interventional

Primary Objective: To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative advanced breast cancer. Secondary Objective: - To characterize the overall safety profile of SAR439859 administered as monotherapy. - To characterize the pharmacokinetic profile of SAR439859 administered as monotherapy. - To evaluate the antitumor activity of SAR439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).

NCT ID: NCT03816163 Active, not recruiting - Pancreatic Cancer Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

Start date: March 15, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM, determine overall survival and assess the safety and tolerability of the combination treatment. This study will also evaluate tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM, and health-related quality of life (HRQoL).

NCT ID: NCT03815643 Active, not recruiting - Solid Tumors Clinical Trials

Avelumab Program Rollover Study

Start date: March 22, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study.

NCT ID: NCT03811535 Active, not recruiting - Clinical trials for Growth Hormone Deficiency in Children

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

REAL4
Start date: May 20, 2019
Phase: Phase 3
Study type: Interventional

The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

NCT ID: NCT03811002 Active, not recruiting - Clinical trials for Stage III Lung Cancer AJCC v8

Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC)

Start date: July 26, 2019
Phase: Phase 3
Study type: Interventional

This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.

NCT ID: NCT03807778 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer

Start date: February 4, 2019
Phase: Phase 1
Study type: Interventional

This study is in 2 parts. Different participants will take part in the 1st and 2nd parts of the study. The main aim of the 1st part of the study is to check how much Mobocertinib adults with non-small cell lung cancer (NSCLC) can receive without getting side effects from it. The main aim of the 2nd part of the study is to learn if the condition of adults with non-small cell lung cancer improves after treatment with Mobocertinib. Another aim is to continue checking for side effects from Mobocertinib. In the 1st part of the study, at the first visit, the study doctor will check who can take part. For those that can take part, participants will take a capsule of Mobocertinib once a day for 28 days. This will count as 1 cycle. Different small groups of participants will receive lower to higher doses of Mobocertinib. The study doctors will check for side effects after each dose of TAK 788. In this way, researchers can work out the best dose of Mobocertinib to give participants in the 2nd part of the study. Participants will visit the clinic 30 days after their treatment has finished for a final check-up. In the 2nd part of the study, at the first visit, the study doctor will check who can take part. Participants will receive the best dose of Mobocertinib worked out from the 1st part of the study. Participants will receive Mobocertinib in the same way as those from the 1st part of the study. The study doctors will learn if the condition of these participants improves after treatment with Mobocertinib. The study doctors will also check for side effects from Mobocertinib. After treatment has finished, participants will visit the clinic every 12 weeks until the end of the study. In both parts of the study, participants can receive Mobocertinib for up to just over 1 year, or longer if their condition stays improved.

NCT ID: NCT03800134 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

AEGEAN
Start date: December 6, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

NCT ID: NCT03798626 Active, not recruiting - Colorectal Cancer Clinical Trials

Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers

Start date: May 22, 2019
Phase: Phase 1
Study type: Interventional

This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.

NCT ID: NCT03783442 Active, not recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma (ESCC)

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

Start date: December 11, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).

NCT ID: NCT03778957 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

EMERALD-1
Start date: November 30, 2018
Phase: Phase 3
Study type: Interventional

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma