Clinical trials: Phase 1b
Malaria
Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP
A single-centre Phase 1b study to assess the safety, tolerability, pharmacokinetic profile, and antimalarial activity of single doses of coadministered artefenomel (OZ439) and piperaquine phosphate (PQP) against early Plasmodium…
- Trial name
- NCT03542149
- Testing
- 480 mg Piperaquine phosphate, 640 mg Piperaquine phosphate, 200 mg OZ 439
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Hepatocellular Carcinoma
A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma
This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC).
- Trial name
- NCT03006926
- Testing
- lenvatinib, pembrolizumab (200 mg)
- Where
- 26 sites in United States, France and 5 more
- Volunteers
- 104 people
- Sponsor
- Eisai Co., Ltd.
Carcinoma, Non-Small-Cell Lung
Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC
This is a multi-center, open-label, nonrandomized, dose-escalation, Phase 1b study of carotuximab in combination with standard dose nivolumab in patients with NSCLC that has progressed on or after platinum-based chemotherapy or…
- Trial name
- NCT03181308
- Testing
- Carotuximab (TRC105), OPDIVO
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Tracon Pharmaceuticals Inc.
Solid Tumors
Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer
In the dose escalation phase (Part 1), this study will determine the dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) and recommended Phase 2 (RPII) dose of NC 6004 in combination with gemcitabine.
- Trial name
- NCT02240238
- Testing
- NC-6004, Gemcitabine
- Where
- 22 sites in United States, Bulgaria and 3 more
- Volunteers
- 119 people
- Sponsor
- NanoCarrier Co., Ltd.
Diabetes Mellitus, Type 1
OPT101 in Type 1 Diabetes Patients
Phase 1b designed to assess safety, pharmacokinetics, immunological and clinical effects of multiple ascending doses of OPT101.
- Trial name
- NCT05428943
- Testing
- OPT101
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Op-T LLC
Hepatitis C, Chronic
A Study of Pharmacokinetics, Efficacy, Safety, Tolerability, of the Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV) in Patients With Recurrent Chronic Hepatitis C Genotype 1b Infection After Orthotopic Liver Transplantation
The purpose of the study is to evaluate effect of steady-state (when the amount of drug administered (in a given time period is equal to the amount of drug eliminated in that same period) of simeprevir and daclatasvir on the…
- Trial name
- NCT01938625
- Testing
- Simeprevir, Daclatasvir, Ribavirin
- Where
- 6 sites in Germany, Poland and 1 more
- Volunteers
- 35 people
- Sponsor
- Janssen R&D Ireland
Chronic Hepatitis C
Safety and PK Study of MP-424 to Treat Chronic Hepatitis C
The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C.
- Trial name
- NCT00591214
- Testing
- MP-424 (Telaprevir)
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Tanabe Pharma Corporation
Carcinoma, Non-Small-Cell Lung
A Study of XL184 (Cabozantinib) With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer (NSCLC)
The study consisted of a Phase 1 dose escalation/dose de-escalation portion to determine a safe and tolerable combination dose(s) of cabozantinib and erlotinib, and a Phase 2 Simon optimal 2-stage design portion with randomized…
- Trial name
- NCT00596648
- Testing
- XL184, erlotinib
- Where
- 13 sites in United States
- Volunteers
- 92 people
- Sponsor
- Exelixis
Small Cell Lung Cancer
Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced…
- Trial name
- NCT02514447
- Testing
- Trilaciclib, Topotecan
- Where
- 50 sites in United States, Belgium and 6 more
- Volunteers
- 123 people
- Sponsor
- G1 Therapeutics, Inc.
Solid Tumor, Non-Small Cell Lung Cancer Recurrent
A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma
The main purpose of this study is to evaluate the safety, tolerability, and efficacy of the study drug known as galunisertib in combination with nivolumab in participants with advanced refractory solid tumors and in recurrent or…
- Conditions
- Solid Tumor, Non-Small Cell Lung Cancer Recurrent, Hepatocellular Carcinoma Recurrent
- Trial name
- NCT02423343
- Testing
- Galunisertib, Nivolumab
- Where
- 9 sites in United States, Spain
- Volunteers
- 41 people
- Sponsor
- Eli Lilly and Company
Advanced Solid Tumors, Head and Neck Cancer
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
Phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid tumors.
- Conditions
- Advanced Solid Tumors, Head and Neck Cancer, Pancreatic Cancer, Ovarian Cancer
- Trial name
- FPA008-003 (NCT02526017)
- Testing
- Cabiralizumab, Nivolumab
- Where
- 39 sites in United States
- Volunteers
- 313 people
- Sponsor
- Five Prime Therapeutics, Inc.
Advanced Cancer
Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers
The purpose of this study is to determine if it is possible to make and administer safely a 'personalized' vaccine to treat patients that have been diagnosed with advanced cancer and are not candidates for curative therapy.
- Trial name
- NCT03568058
- Testing
- Personalized Vaccine, Pembrolizumab
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Aaron Miller
Adenocarcinoma
Study of Weekly Paclitaxel With Ramucirumab in Participants With Advanced Gastric Adenocarcinomas
Investigate the safety and tolerability of ramucirumab (IMC-1121B) drug product (DP) in combination with paclitaxel.
- Trial name
- NCT01253525
- Testing
- Ramucirumab (IMC-1121B ), Paclitaxel
- Where
- 3 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Eli Lilly and Company
Acute Myeloid Leukemia
Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
This is a phase 1b, dose escalation, study of quizartinib to evaluate the safety profile, the pharmacokinetics, and the recommended dose of quizartinib for subsequent clinical studies of the combination of quizartinib and…
- Trial name
- NCT02834390
- Testing
- Quizartinib, Cytarabine, Idarubicin
- Where
- Japan
- Volunteers
- 7 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Pulmonary Hypertension
Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension
mTOR activation has been shown to be relevant in the development and progression of pulmonary hypertension. Inhibition of mTOR has been shown to reverse or regress pulmonary hypertension in animal models.
- Trial name
- NCT02587325
- Testing
- nab-sirolimus
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Aadi Bioscience, Inc.
Huntington's Disease
Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
PRECISION-HD2 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120102 in…
- Trial name
- PRECISION-HD2 (NCT03225846)
- Testing
- WVE-120102
- Where
- 26 sites in United States, Australia and 6 more
- Volunteers
- 88 people
- Sponsor
- Wave Life Sciences USA, Inc.
Metastases, Neoplasm, Carcinoma, Non-small Cell Lung
A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors
Study I3G-MC-JGCB (JGCB) is a multicenter, nonrandomized, open-label, dose-escalation Phase 1b study of LY2584702 in combination with either erlotinib or everolimus.
- Conditions
- Metastases, Neoplasm, Carcinoma, Non-small Cell Lung, Renal Cell Carcinoma, Neuroendocrine Tumors
- Trial name
- NCT01115803
- Testing
- LY2584702, Erlotinib, Everolimus
- Where
- 3 sites in United States, France
- Volunteers
- 29 people
- Sponsor
- Eli Lilly and Company
Fungal Infections
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)
The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.
- Trial name
- NCT01716234
- Testing
- Posaconazole 12 mg/kg/day BID, Posaconazole 18 mg/kg/day BID, Posaconazole 18 mg/kg/day TID
- Volunteers
- 142 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Non-Hematologic Malignancies
CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies
This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel in patients with non-hematologic…
- Trial name
- NCT01653158
- Testing
- CP-751,871, Docetaxel
- Where
- United Kingdom
- Volunteers
- 46 people
- Sponsor
- Pfizer
Acute Myelogenous Leukemia
Study of MLN4924 Plus Azacitidine in Treatment-naive Participants With Acute Myelogenous Leukemia (AML) Who Are 60 Years or Older
The purpose of this study is to establish the maximum tolerated dose (MTD), and to assess the safety and tolerability of MLN4924 (pevonedistat) in combination with azacitidine in treatment naive participants with AML who were 60…
- Trial name
- NCT01814826
- Testing
- MLN4924, Azacitidine
- Where
- 8 sites in United States
- Volunteers
- 64 people
- Sponsor
- Millennium Pharmaceuticals, Inc.