Clinical trials: Genetic Mutation
Metastatic Melanoma, BRAF V600 Mutation Positive
A Study to Investigate the Effect of Itraconazole and Rifampin on Pharmacokinetics (PK) of Vemurafenib at Steady State
This is a two-part, Phase 1, open-label, multicenter, two-period, one-sequence study to investigate the effect of itraconazole and rifampin on the PK of vemurafenib following multiple 960 milligrams (mg) twice daily (BID) dosing…
- Trial name
- NCT02608034
- Testing
- Itraconazole, Rifampin, Vemurafenib
- Where
- 11 sites in United States, Israel and 2 more
- Volunteers
- 32 people
- Sponsor
- Genentech, Inc.
Metastatic Breast Cancer
Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer
The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel…
- Trial name
- NCT01506609
- Testing
- Veliparib, Carboplatin, Temozolomide
- Where
- 120 sites in United States, Argentina and 18 more
- Volunteers
- 294 people
- Sponsor
- AbbVie
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)
The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- MARCH-PFIC (NCT03905330)
- Testing
- Maralixibat
- Where
- 31 sites in United States, Argentina and 15 more
- Volunteers
- 93 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cancer
Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam
This is an open-label, multi-center, fixed sequence study in subjects with BRAF V600 mutation positive tumors. Subjects will receive single oral doses of 10 milligram (mg) of rosuvastatin and 3 mg of midazolam in the morning of…
- Trial name
- NCT02082665
- Testing
- Rosuvastatin10 mg tablet, Midazolam 3 mg syrup, Dabrafenib 75 mg capsule
- Where
- 4 sites in United States, Spain
- Volunteers
- 6 people
- Sponsor
- GlaxoSmithKline
Solid Tumor Malignancies
A Study to Investigate the Safety and Efficacy of KQB548 in Participants With Advanced Solid Malignancies
The goal of this trial is to learn if KQB548 works to treat patients with advanced solid malignancies with a KRAS G12D mutation. It will also learn about the safety of KQB548.
- Trial name
- NCT07207707
- Testing
- KQB548
- Where
- 13 sites in United States
- Volunteers
- 78 people
- Sponsor
- Kumquat Biosciences Inc.
Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer
A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors
This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult
- Trial name
- NCT07020221
- Testing
- VS-7375, Cetuximab, Carboplatin + Pemetrexed + Pembrolizumab
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 616 people
- Sponsor
- Verastem, Inc.
Non-small Cell Lung Cancer
Tepotinib With Gefitinib in Participants With Locally Advanced or Metastatic NSCLC (INSIGHT)
This is a multi-center, open-label, randomized, Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) and to evaluate the efficacy in terms of progression free survival (PFS) of Tepotinib when used in combination with…
- Trial name
- NCT01982955
- Testing
- Tepotinib, Gefitinib, Pemetrexed
- Where
- 44 sites in China, Italy and 5 more
- Volunteers
- 88 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Carcinoma, Non-Small-Cell Lung
An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI
- Trial name
- NCT01853826
- Testing
- Afatinib
- Where
- 118 sites in Australia, Austria and 9 more
- Volunteers
- 481 people
- Sponsor
- Boehringer Ingelheim
Acute Myeloid Leukemia With Gene Mutations
Expanded Treatment Protocol for Adults With FLT3-ITD Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) to Receive Quizartinib
An expanded access program (EAP): Allows doctors to give medicine to patients, Before it is approved by health authorities. This EAP is for: Quizartinib Patients with FLT3-ITD mutated AML, AML that has come back, or Is resistant…
- Trial name
- NCT03746912
- Testing
- Quizartinib Dihydrochloride
- Sponsor
- Daiichi Sankyo
Non Small Cell Lung Cancer
Phase II Trial to Evaluate the Efficacy and Safety of HM61713 as the 1st-line NSCLC Anticancer Therapy
A multi-center, single-arm. Phase 2 exploratory trial to evaluate the efficacy and safety of HM61713 as the 1st-line anticancer agent in none-small cell lung cancer patients with EGFR mutation
- Trial name
- NCT02444819
- Testing
- HM61713
- Where
- South Korea
- Volunteers
- 33 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Chronic Lymphocytic Leukemia (CLL)
A Study to Compare the Efficacy and Safety of a Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/ Bendamustine And Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL (17P) or TP53 Mutation
This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a…
- Trial name
- CRISTALLO (NCT04285567)
- Testing
- Obinutuzumab, Venetoclax, Fludarabine
- Where
- 40 sites in United States, Australia and 3 more
- Volunteers
- 166 people
- Sponsor
- Hoffmann-La Roche
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Locally Advanced or Metastatic NSCLC
ASK120067 Versus Gefitinib as First-line Treatment for EGFRm Locally Advanced or Metastatic NSCLC
To assess the efficacy and safety of ASK120067 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor Gefitinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
- Trial name
- NCT04143607
- Testing
- ASK120067, Gefitinib
- Where
- 3 sites in China
- Volunteers
- 337 people
- Sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by…
- Conditions
- RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms
- Trial name
- AcceleRET-Lung (NCT04222972)
- Testing
- Pralsetinib, Carboplatin, Cisplatin
- Where
- 74 sites in Argentina, Australia and 20 more
- Volunteers
- 223 people
- Sponsor
- Hoffmann-La Roche
Anticancer Treatment
AZD9291 (Osimertinib) Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal…
- Trial name
- AURA3 (NCT02151981)
- Testing
- Chemotherapy, Cross-over to Osimertinib
- Where
- 150 sites in United States, Australia and 16 more
- Volunteers
- 421 people
- Sponsor
- AstraZeneca
Nonsmall-cell Lung Cancer
Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2)
This study is designed to evaluate safety and antitumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. This is the first time the drug is tested in human.
- Trial name
- NCT06813365
- Testing
- DZD6008
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Dizal Pharmaceuticals
Advanced Non-small Cell Lung Cancer, EGFR Mutation
First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body.
- Conditions
- Advanced Non-small Cell Lung Cancer, EGFR Mutation, HER2 Mutation
- Trial name
- NCT05099172
- Testing
- BAY2927088_formulation A, BAY2927088_formulation B_1, BAY2927088_formulation B_2
- Where
- 94 sites in United States, Belgium and 14 more
- Volunteers
- 430 people
- Sponsor
- Bayer
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC.
- Trial name
- SUNRAY-01 (NCT06119581)
- Testing
- LY3537982, Pembrolizumab, Cisplatin
- Where
- 415 sites in United States, Australia and 27 more
- Volunteers
- 1,264 people
- Sponsor
- Eli Lilly and Company
Retinitis Pigmentosa (RP)
Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65)
The purpose of this study is: To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in RP subjects with an autosomal dominant mutation in RPE65.
- Trial name
- NCT01543906
- Testing
- QLT091001
- Where
- 2 sites in Canada, Ireland
- Volunteers
- 5 people
- Sponsor
- QLT Inc.
EGFR Mutant Advanced Non-Small Cell Lung Cancer
First-in-Human Study of BBT-207 in Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation After Treatment With EGFR TKI
This is an open label, multi-center, Phase 1/2 study evaluating the safety, tolerability, PK, PD, and preliminary efficacy (antitumor activity) of BBT-207.
- Trial name
- NCT05920135
- Testing
- BBT-207
- Where
- 3 sites in South Korea
- Volunteers
- 24 people
- Sponsor
- Bridge Biotherapeutics, Inc.
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