Clinical trials: Phase I
Acute Myeloid Leukemia
Decitabine and Talazoparib in Untreated AML and R/R AML
The purpose of this study is to find the best way to combine a new chemotherapy drug with one that is already in use to treat AML.
- Trial name
- 1565GCC (NCT02878785)
- Testing
- Decitabine, talazoparib
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Maryland, Baltimore
Breast Cancer
Trastuzumab in Treating Older Women With Early-Stage Breast Cancer
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- NCT00796978
- Testing
- trastuzumab, laboratory biomarker analysis, adjuvant therapy
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cynthia Owusu, MD
Pharmacokinetics
Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects
This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males.
- Trial name
- NCT02802735
- Testing
- Apremilast
- Where
- South Korea
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Amgen
Multiple Myeloma and Plasma Cell Neoplasm
Bortezomib, Doxorubicin Hydrochloride Liposome, and Thalidomide as First-line Therapy in Treating Patients With Previously Untreated Stage I, II, or III Multiple Myeloma
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth…
- Trial name
- NCT00523848
- Testing
- bortezomib, pegylated liposomal doxorubicin hydrochloride, thalidomide
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Roswell Park Cancer Institute
Acute Ischemic Stroke
Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy
The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours.
- Trial name
- NCT03198715
- Testing
- DS1040b
- Where
- 20 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Amenorrhea
Study to Evaluate Menses Induction in Women Administered Proellex
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
- Trial name
- NCT00881608
- Testing
- Proellex
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Healthy
A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers
This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in…
- Trial name
- NCT00901576
- Testing
- SPD503, Concerta, SPD503 + Concerta
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Shire
HIV Infections
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion…
- Trial name
- NCT03928821
- Testing
- PGT121, PGDM1400, 10-1074
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
The purpose of this study is to learn about the side effects (safety) of the study medicine PF-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate COVID-19 infection in adults with severe renal impairment.
- Trial name
- NCT05487040
- Testing
- PF-07321332 (nirmatrelvir)/ritonavir
- Where
- 52 sites in United States
- Volunteers
- 15 people
- Sponsor
- Pfizer
Relapsed, Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05)
This study is a phase 1, dose finding, open-label study in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
- Trial name
- NCT02658968
- Testing
- Betalutin
- Where
- 10 sites in United States, Germany and 3 more
- Volunteers
- 18 people
- Sponsor
- Nordic Nanovector
Healthy
Compare IBI305 and Bevacizumab on Pharmacokinetics/Safety/Immunogenicity on Healthy Male
To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .
- Trial name
- NCT03083990
- Testing
- IBI305(Bevacizumab Biosimilar), Avastin(Bevacizumab)
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Recurrent Pediatric ALL, Relapsed Pediatric ALL
ABT-751 With Chemotherapy for Relapsed Pediatric ALL
This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred).
- Conditions
- Recurrent Pediatric ALL, Relapsed Pediatric ALL, Acute Lymphoblastic Leukemia, Refractory Pediatric ALL
- Trial name
- NCT00439296
- Testing
- ABT-751, Dexamethasone, PEG-asparaginase
- Where
- 5 sites in United States
- Volunteers
- 9 people
- Sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
Cancer: Solid Tumors
An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors
The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no…
- Trial name
- NCT00280397
- Testing
- E7080
- Where
- Japan
- Volunteers
- 27 people
- Sponsor
- Eisai Inc.
Pediatric Brain Tumor, Diffuse Intrinsic Pontine Glioma
A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG
This research study involves an investigational product: Ad-RTS-hIL-12 given with veledimex for production of human IL-12. IL-12 is a protein that can improve the body's natural response to disease by enhancing the ability of the…
- Trial name
- NCT03330197
- Testing
- Ad-RTS-hIL-12, Oral Veledimex - Arm 1 (Pediatric Brain Tumor), Oral Veledimex - Arm 2 (DIPG)
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Alaunos Therapeutics
Metastatic Cancer, Solid Tumor
Sym022 (Anti-LAG-3) in Patients With Advanced Solid Tumor Malignancies or Lymphomas
This is the first study to test Sym022 in humans. The primary purpose of this study is to see if Sym022 is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas…
- Conditions
- Metastatic Cancer, Solid Tumor, Lymphoma
- Trial name
- NCT03489369
- Testing
- Sym022
- Where
- 3 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- Symphogen A/S
HTLV-I Infection, T Cell Leukemia
Anti-Tac for Treatment of Leukemia
The purpose of the study was to determine: (1) the toxicity and maximum tolerated dose (MTD) of humanized anti-Tac (daclizumab), (Zenapax(Registered Trademark)) in patients with adult T-cell leukemia/lymphoma (ATL); (2) to define…
- Trial name
- NCT00001941
- Testing
- daclizumab
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- National Cancer Institute (NCI)
Hepatitis B
Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B
This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir.
- Trial name
- NCT02496897
- Testing
- FP-02.2 Vaccine, IC31® Adjuvant
- Where
- 21 sites in South Korea, United Kingdom
- Volunteers
- 61 people
- Sponsor
- Altimmune, Inc.
Advanced Malignancies, Advanced Cancer
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen
The purpose of this study was to evaluate the safety, tolerability, and clinical response of ASP7517, and determine the Recommended Phase 2 Dose (RP2D) and/or the Maximum Tolerated Dose (MTD) of ASP7517 when administered as a…
- Trial name
- NCT04837196
- Testing
- ASP7517, Pembrolizumab
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Multiple Myeloma
A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma
This is an open-label, multicentre, dose escalation study to characterize the safety and preliminary efficacy of the human anti-CD38 antibody MOR03087 (MOR202), in adult subjects with relapsed/refractory multiple myeloma, as…
- Trial name
- NCT01421186
- Testing
- MOR03087 phase 1 dose escalation, MOR03087, Dexamethasone
- Where
- 10 sites in Austria, Germany
- Volunteers
- 91 people
- Sponsor
- MorphoSys AG
Stage I Non-Small Cell Lung Cancer, Stage IA Non-Small Cell Lung Cancer
Osimertinib in Treating Participants With Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer Before Surgery
This phase II trial studies how well osimertinib works in treating participants with stage I-IIIA Epithelial Growth Factor Receptor (EGFR) -mutant non-small cell lung cancer before surgery.
- Conditions
- Stage I Non-Small Cell Lung Cancer, Stage IA Non-Small Cell Lung Cancer, Stage IB Non-Small Cell Lung Cancer, Stage II Non-Small Cell Lung Cancer
- Trial name
- NCT03433469
- Testing
- Osimertinib, Therapeutic Conventional Surgery
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- University of California, San Francisco
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