Clinical trials: Maximum Tolerated Dose
Leukemia, Myeloid, Acute
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
Phase I Dose Escalation: Primary objective is to determine the Maximum Tolerated Dose (MTD) and the recommended dose for Phase I Extension.
- Trial name
- NCT02632721
- Testing
- Decitabine, BI 836858
- Where
- 14 sites in United States, Germany and 2 more
- Volunteers
- 49 people
- Sponsor
- Boehringer Ingelheim
Renal Cell Carcinoma, Hereditary Leiomyomatosis
Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma
Background: There are no established treatments for people with certain advanced kidney cancers. These tumors often don't respond well to currently available treatments.
- Conditions
- Renal Cell Carcinoma, Hereditary Leiomyomatosis, Renal Cell Cancer
- Trial name
- NCT02495103
- Testing
- Vandetanib, Metformin, Vandetanib/Metformin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Solid Tumors
An Open-label, Dose Escalation, Pharmacodynamic, Pharmacokinetic, and Effect of Food Phase 1 Study of E7820 to Determine the Maximum Tolerated Dose Following Twice Daily Oral Administration in Subjects With Unresectable Solid Tumors
This study consists of two Parts. Part A (Food Effect Study) and Part B (Determination of Maximum Tolerated Dose [MTD] for twice daily [BID] Dosing).Part A will be initiated first, and Part B will be initiated after the PK…
- Trial name
- NCT01773421
- Testing
- E7820
- Where
- 6 sites in Netherlands, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Eisai Inc.
Advanced Solid Tumor, Lung Cancer
Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor
This Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics (PK) profile and preliminary efficacy of intratumoral injection of Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in patients with advanced…
- Conditions
- Advanced Solid Tumor, Lung Cancer, Pancreas Cancer, Breast Cancer
- Trial name
- CNSI-Fe(II) (NCT06048367)
- Testing
- CNSI-Fe(II) 30 mg, CNSI-Fe(II) 60 mg, CNSI-Fe(II) 90 mg
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Sichuan Enray Pharmaceutical Sciences Company
Advanced Solid Tumors
A Phase 1/2, Open-Label, Dose-Escalation Study of JI-101, in Patients With Advanced Solid Tumors
The purpose of this study, the first clinical trial of JI-101, is to determine the maximum tolerated dose of JI-101 when given orally to patients with solid tumors.
- Trial name
- NCT00842335
- Testing
- JI-101
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Jubilant Innovation Ltd.
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML
To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) and…
- Trial name
- NCT01957644
- Testing
- Azacitidine, Volasertib
- Where
- 14 sites in France, Germany
- Volunteers
- 16 people
- Sponsor
- Boehringer Ingelheim
Leukemia, Neoplasms
Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known
The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group…
- Trial name
- NCT01971476
- Testing
- volasertib
- Where
- 5 sites in Belgium, Czechia and 3 more
- Volunteers
- 22 people
- Sponsor
- Boehringer Ingelheim
Diabetes, Diabetes Mellitus, Type 2
A Trial Investigating the Efficacy and Safety of Insulin Detemir Versus Insulin NPH in Combination With Metformin and Diet/Exercise in Children and Adolescents With Type 2 Diabetes Insufficiently Controlled on Metformin With or Without Other Oral Antidiabetic Drug(s) With or Without Basal Insulin
This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of insulin detemir versus insulin Neutral Protamine Hagedorn (NPH) in combination with the maximum tolerated dose of metformin and…
- Trial name
- iDEAt2 (NCT02131272)
- Testing
- Insulin detemir, Insulin NPH, Diet/exercise
- Where
- 82 sites in United States, Argentina and 22 more
- Volunteers
- 42 people
- Sponsor
- Novo Nordisk A/S
Rheumatoid Arthritis
Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients
Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate.
- Trial name
- NCT00669942
- Testing
- AIN457
- Where
- 24 sites in United States, Belgium and 4 more
- Volunteers
- 104 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against human IL-17 - BCD-085.
- Trial name
- NCT02380287
- Testing
- humanized monoclonal antibody against human IL-17
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Biocad
Leukemia, Myeloid, Myelodysplastic Syndromes
Lenalidomide After Allo-Hematopoietic Cell Transplant (HCT) in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS) Subjects With Minimal Residual Disease
The purpose of this study is to determine the maximum tolerated dose, dose limiting side effects, and the safety of increasing doses of lenalidomide in patients with AML and MDS who have a small amount of detectable disease after…
- Trial name
- UF-BMT-MRD-101 (NCT02370888)
- Testing
- Lenalidomide
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Florida
Metastatic Soft-tissue Sarcoma
A Study of NOX66 Plus Doxorubicin in Anthracycline-naïve, Adult Patients With Soft Tissue Sarcoma
This is a Phase I, open-label, dose-escalation and dose-expansion study of NOX66 given rectally, in cohorts of patients with metastatic soft tissue sarcoma (STS) who have not been exposed to anthracycline therapy, using a fixed…
- Trial name
- NCT05100628
- Testing
- NOX66, Doxorubicin
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Noxopharm Limited
Non-Hodgkin's B-cell Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
The purpose of this study is to evaluate the safety and tolerability of MT-3724 in subjects with relapsed or refractory B-Cell NHL or relapsed and refractory CLL (Part 1 only) and relapsed and refractory DLBCL (Part 2 and Part…
- Conditions
- Non-Hodgkin's B-cell Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Small Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma
- Trial name
- MT-3724NHL001 (NCT02361346)
- Testing
- MT-3724 Phase 1, MT-3724 Phase 2
- Where
- 41 sites in United States, Belarus and 8 more
- Volunteers
- 38 people
- Sponsor
- Molecular Templates, Inc.
Carcinoma, Non-Small-Cell Lung
A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations
This trial is divided into Part A and Part B. The primary objective of Part A is to establish the Maximal Tolerated Dose of intermittent high dose afatinib.
- Trial name
- NCT01647711
- Testing
- Dose escalation followed by treatment with MTD
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Boehringer Ingelheim
Neoplasms
Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours
Study to determine the maximum tolerated dose of BIBW 2992 when combined with backbone chemotherapies consisting in cisplatin plus paclitaxel or cisplatin plus 5 FU.
- Trial name
- NCT00716417
- Testing
- BIBW 2992
- Where
- 3 sites in Belgium
- Volunteers
- 47 people
- Sponsor
- Boehringer Ingelheim
Non-small Cell Lung Cancer
Maximum Tolerated Dose, Safety and Efficacy of Docetaxel / Cisplatin + STI571
This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC). This research study has 2 parts to it.
- Trial name
- NCT02127372
- Testing
- Docetaxel, Cisplatin and STI571, Docetaxel, Cisplatin
- Volunteers
- 43 people
- Sponsor
- Duke University
Advanced Solid Tumors
Study of PARPi 2X-121 as Monotherapy and in Combination With Dovitinib in Patients With Advanced Solid Tumors
This is a Phase Ib, two-part, multi-center study. In Part 1, the study will evaluate the safety and tolerability, antitumor activity, pharmacokinetics, and determine the maximum tolerated dose (MTD) of 2X-121 monotherapy (at BID…
- Trial name
- NCT05571969
- Testing
- 2X-121 600 mg, 2X-121 800 mg, 2X-121 1000 mg
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- Allarity Therapeutics
Colorectal Neoplasms, Colorectal Carcinoma
ISIS 183750 With Irinotecan for Advanced Solid Tumors or Colorectal Cancer
Background: Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the deoxyribonucleic acid (DNA) of growing cancer cells. It is most often used with other chemotherapy drugs.
- Conditions
- Colorectal Neoplasms, Colorectal Carcinoma, Colorectal Tumors
- Trial name
- NCT01675128
- Testing
- ISIS 183750, Irinotecan
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- National Cancer Institute (NCI)
Melanoma, Prostate Cancer
A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with…
- Conditions
- Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma
- Trial name
- IVY (NCT02009449)
- Testing
- Pegilodecakin, Paclitaxel or Docetaxel and Carboplatin or Cisplatin, FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
- Where
- 10 sites in United States
- Volunteers
- 353 people
- Sponsor
- Eli Lilly and Company
Advanced Solid Tumors
First-in-human Study of M4076 in Advanced Solid Tumors (DDRiver Solid Tumors 410)
The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with…
- Trial name
- NCT04882917
- Testing
- M4076
- Where
- 3 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.