Clinical trials: Maximum Tolerated Dose
Glioblastoma Multiforme, Anaplastic Astrocytoma
Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 2
The primary objectives of this study are to determine the maximal tolerated dose (MTD) of PAC-1 in combination with temozolomide in patients with high grade glioma: glioblastoma multiforme (GBM) or anaplastic astrocytoma after…
- Trial name
- NCT03332355
- Testing
- PAC-1 Compound
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Vanquish Oncology, Inc.
Chronic Myeloid Leukemia
Determining the Maximum Tolerated Dose of Low Dose Interferon-alpha in Conjunction With Nilotinib in Pretreated Philadelphia Chromosome Positive (Ph+) Chronic Myeloid Leukemia Patients in Chronic Phase (CML-CP)
This study will assess the maximum tolerated dose of low dose interferon in conjunction with nilotinib in pretreated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in chronic phase (CML-CP).
- Trial name
- NICOLI (NCT01220648)
- Testing
- Nilotinib, interferon-alfa
- Where
- Germany
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Hepatocellular Carcinoma
Phase Ib/2, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Hepatocellular Carcinoma
The purpose of this study is to assess the safety and tolerability of the investigational anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid particle suspension that targets the oncogene…
- Trial name
- NCT02314052
- Testing
- DCR-MYC
- Where
- 6 sites in United States, Singapore and 1 more
- Volunteers
- 21 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
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
Solid Tumor
Clinical Study of Liposomal Paclitaxel in Chinese Patients
The purpose of this study is to determine the maximum tolerated dose and dose limiting toxicities of liposomal paclitaxel in Chinese patients with solid tumors in advanced stages.
- Trial name
- NCT00881101
- Testing
- Liposomal paclitaxel
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Nanjing Sike Pharmaceutical Co., Ltd.
RSV Infection
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
ALX-0171 is a Nanobody directed against the human respiratory syncytial virus (RSV). The purpose of this first-in-man study is to determine the safety, tolerability and pharmacokinetics (PK) of ALX-0171 after single and multiple…
- Trial name
- NCT01483911
- Testing
- ALX-0171
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ablynx, a Sanofi company
Metastatic Solid Tumors, Esophageal Cancer
M1231 in Participants With Solid Tumors
This study is to establish a safe and tolerable dose and to investigate pharmacokinetics and the first clinical efficacy signals of M1231 as a single agent in participants with solid tumors (Part 1) and with metastatic Non-small…
- Conditions
- Metastatic Solid Tumors, Esophageal Cancer, Non-Small Cell Lung Cancer
- Trial name
- NCT04695847
- Testing
- M1231
- Where
- 3 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Malignant Solid Tumour
To Determine the Maximum Tolerated Dose (MTD) of BIBF 1120 in Patients With Solid Tumours
The primary objective of this study was to determine the maximum tolerated dose (MTD) of BIBF 1120 in patients with solid tumours by the monitoring of drug-related adverse events.
- Trial name
- NCT01951846
- Testing
- BIBF 1120
- Where
- Germany
- Volunteers
- 61 people
- Sponsor
- Boehringer Ingelheim
Neoplasms
Phase I Dose Escalation Study With an Allosteric AKT 1/2 Inhibitor in Patients
This is the first study where BAY1125976 is given to humans. Patients (all comers) will receive the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated…
- Trial name
- NCT01915576
- Testing
- BAY1125976
- Where
- 7 sites in United States, France and 2 more
- Volunteers
- 79 people
- Sponsor
- Bayer
Colorectal Cancer
A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer
This is a multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists of Part A (single agent SC-006 dose regimen…
- Trial name
- NCT03035279
- Testing
- SC-006, ABBV-181
- Where
- 9 sites in United States
- Volunteers
- 29 people
- Sponsor
- AbbVie
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
Sarcoma, Neuroblastoma
To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
Background: Marqibo(Registered Trademark) is a new anticancer drug. It combines Vincristine sulfate, which is a widely used anticancer drug, and packages it into a tiny fat bubble known as a liposome.
- Conditions
- Sarcoma, Neuroblastoma, Wilms Tumor, Leukemia
- Trial name
- NCT01222780
- Testing
- Marqibo
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Acrotech Biopharma Inc.
Pain, Acute Pain
A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure to Investigate the Safety and Tolerability of GRT0151Y and to Find Out Which Single Dose of the Compound is Maximally Tolerated
The purpose of this study is to determine the maximum dose of GRT0151Y that is tolerable and to explore the safety profile of the drug. For each Treatment Period (Visits 2-5), dosing will be separated by at least one week.
- Conditions
- Pain, Acute Pain, Chronic Pain
- Trial name
- NCT03765658
- Testing
- GRT0151Y dose escalation
- Where
- Canada
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Neoplasms
Phase I Dose Escalation Study for VIP152 in Patients With Advanced Cancer
Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) as monotherapy or in combination in patients with solid tumors and aggressive…
- Trial name
- NCT02635672
- Testing
- VIP152 (BAY 1251152), VIP152 (BAY 1251152) 30 mg, Keytruda
- Where
- 16 sites in United States, Chile and 1 more
- Volunteers
- 110 people
- Sponsor
- Vincerx Pharma, Inc.
Advanced Malignancy, Advanced Solid Cancers
ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers
The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors.
- Conditions
- Advanced Malignancy, Advanced Solid Cancers, Metastatic Solid Tumors
- Trial name
- NCT07238075
- Testing
- ADCX-020
- Where
- 9 sites in Australia, Spain
- Volunteers
- 290 people
- Sponsor
- Adcytherix SAS
Leukemia, Myeloid, Acute
BI 811283 in Combination With Cytarabine in Previously Untreated AML Ineligible for Intensive Treatment
Investigation of maximum tolerated dose, safety, efficacy and pharmcokinetics of BI 811283 in combination with cytarabine (LD-Ara-C) in previously untreated acute myeloid leukaemia (AML) patients
- Trial name
- NCT00632749
- Testing
- BI 811283 (d 1 and 15), Cytarabine, BI 811283 (d1)
- Where
- 7 sites in Germany
- Volunteers
- 68 people
- Sponsor
- Boehringer Ingelheim
Advanced Solid Malignancies
Clinical Trial to Evaluate Safety and Tolerability of OratecanTM in Patients With Advanced Solid Malignancies (Oratecan-102)
The main objective of this study is to determine the maximum tolerated dose (MTD) of OratecanTM. Eligible subjects of this study are patients with histologically or cytologically confirmed malignant solid tumor refractory to…
- Trial name
- NCT00986843
- Testing
- HM30181AK tablet + Irinotecan tablets
- Where
- South Korea
- Volunteers
- 14 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Inoperable Solid Tumors or Lymphomas
Safety, Tolerability, PK, Dosimetry, MTD and Preliminary Efficacy of Intra-lesionally Injected AvidinOX, Followed by IV Escalating Doses of [177Lu]DOTA-biotin in Pts With Injectable Solid Tumors or Lymphomas
Local treatment of unresectable tumors is challenging, particularly with radioactivity. Current practice relies on external beam irradiation or on a variety of medical devices for brachytherapy.
- Trial name
- NCT03188328
- Testing
- AvidinOX, 177Lu-ST2210
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Alfasigma S.p.A.
Healthy Volunteer
Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers
This study in healthy human volunteers will investigate the effects of a single dose (SAD) and multiple days of dosing (MAD) of WP1122 administered as an oral (PO) solution.
- Trial name
- NCT05195723
- Testing
- WP1122
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Moleculin Biotech, Inc.
Carcinoma
Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid…
- Trial name
- NCT00941863
- Testing
- Sorafenib 100 mg (50-mg tablet), Sorafenib 200 mg (50-mg tablet), Sorafenib 400 mg (50-mg tablet)
- Where
- 3 sites in United States
- Volunteers
- 158 people
- Sponsor
- Bayer