Clinical trials: CP
CHRONIC MYELOGENOUS LEUKEMIA
Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)
The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib.
- Trial name
- NCT00760877
- Testing
- Nilotinib, Imatinib
- Where
- 30 sites in Argentina, Australia and 4 more
- Volunteers
- 207 people
- Sponsor
- Novartis Pharmaceuticals
Philidelphia Positive Chronic Myeloid Leukaemia
Study to Assess Efficacy and Safety of Nilotinib 300mg Twice Daily in Patients With Philadelphia Positive Chronic Myeloid Leukaemia (CML) in Chronic Phase Who Are Intolerant to Prior Tyrosine Kinase Inhibitors.
The purpose of this Australian study was to assess the efficacy and safety of nilotinib 300mg twice daily in patients with chronic myeloid leukemia chronic phase who were intolerant but responsive to 1st line treatment with…
- Trial name
- ENESTswift (NCT02108951)
- Testing
- Nilotinib
- Where
- 14 sites in Australia
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia
Study of Nilotinib as First Line Treatment in Philadelphia Chromosome Positive(Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
The study was a local multicentric, open-label, non-randomized phase II study of nilotinib as a first line treatment in adult patients with newly-diagnosed Philadelphia chromosome-positive (Ph+) and chronic phase myeloid leukemia…
- Trial name
- NCT01274351
- Testing
- Nilotinib
- Where
- 13 sites in Turkey (Türkiye)
- Volunteers
- 112 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia
A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)
This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult…
- Trial name
- NCT01077544
- Testing
- Nilotinib
- Where
- 12 sites in France, Italy and 2 more
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia
Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs
The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of participants with chronic myeloid leukemia - chronic phase (CML-CP) having previously been treated…
- Trial name
- NCT03106779
- Testing
- Asciminib, Bosutinib
- Where
- 88 sites in United States, Argentina and 23 more
- Volunteers
- 233 people
- Sponsor
- Novartis Pharmaceuticals
CML, Philadelphia Chromosome Positive (Ph+)
Study of Nilotinib in Ph+ CML-CP Patients With Low Imatinib Trough Plasma Concentrations
This study is to determine the number of European Leukemia Network (ELN)guideline defined treatment failure events from time of study entry in CML-CP patients with low imatinib trough concentrations treated with nilotinib.
- Conditions
- CML, Philadelphia Chromosome Positive (Ph+), Chronic Myelogenous Leukemia Chronic Phase(CML-CP) Patients With Low Imatinib Trough Levels
- Trial name
- MACS1148 (NCT01131325)
- Testing
- nilotinib
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia
Asciminib Treatment Optimization in ≥ 3rd Line CML-CP
The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs).
- Trial name
- NCT04948333
- Testing
- ABL001 40mg BID, ABL001 80mg QD, ABL001 200mg QD
- Where
- 48 sites in Argentina, Austria and 14 more
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
Myelogenous Leukemia
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic…
- Trial name
- ENEST (NCT00519090)
- Testing
- Imatinib, Nilotinib (AMN107)
- Where
- 80 sites in United States, Australia and 8 more
- Volunteers
- 6 people
- Sponsor
- Novartis Pharmaceuticals
Philadelphia Chromosome Positive, Chronic Myelogenous Leukemia in Chronic Phase
Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response
To evaluate the major molecular response (MMR) rate at 12 months of nilotinib treatment on study in patients with Philadelphia Chromosome Positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP) who have a suboptimal…
- Trial name
- MACS0911 (NCT01043874)
- Testing
- Nilotinib
- Where
- 20 sites in Japan
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myeloid Leukemia
A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study)
To satisfy a postmarketing requirement, the sponsor has been requested to conduct a Phase 1/Phase 2 single-group clinical study to investigate the pharmacokinetics and preliminary safety and efficacy of omacetaxine following a…
- Trial name
- NCT02078960
- Testing
- Omacetaxine mepesuccinate
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 10 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Chronic Hepatitis C
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)
This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and…
- Trial name
- NCT02115321
- Testing
- Grazoprevir, Elbasvir, MK-5172A
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Myelogenous Leukemia - Chronic Phase
Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
This study was a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior…
- Trial name
- AIM4CML (NCT04666259)
- Testing
- ABL001
- Where
- 26 sites in United States
- Volunteers
- 56 people
- Sponsor
- Novartis Pharmaceuticals
Leukemia, Myeloid, Chronic Phase
Efficacy of 400 Mg Versus 800 Mg Imatinib in Chronic Myeloid Leukemia in Chronic Phase Patients - TOPS (Tyrosine Kinase Inhibitor Optimization and Selectivity)
This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.
- Trial name
- TOPS (NCT00124748)
- Testing
- Imatinib mesylate
- Where
- 75 sites in United States, Argentina and 4 more
- Volunteers
- 476 people
- Sponsor
- Novartis Pharmaceuticals
CML
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve MR4.5
- Trial name
- ENESTgoal (NCT01744665)
- Testing
- nilotinib
- Where
- 54 sites in United States
- Volunteers
- 59 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
Combination Study Of CP-751,871 With Paclitaxel And Carboplatin In Advanced Lung Cancer
Phase 1b Dose Excalation/Expansion: Identify and characterize safety and tolerability of recommended phase 2 dose of CP-751,871 when administered with paclitaxel and carboplatin Phase 1b Erlotinib Extension: To characterize the…
- Trial name
- NCT00147537
- Testing
- CP-751,871, paclitaxel, carboplatin
- Where
- 31 sites in United States, Canada and 2 more
- Volunteers
- 282 people
- Sponsor
- Pfizer
Chronic Myelogenous Leukemia
An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to…
- Trial name
- MACS0999 (NCT00980018)
- Testing
- Nilotinib
- Where
- 23 sites in United States, Canada
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Phase Chronic Myeloid Leukemia
A Study Comparing Ponatinib and Nilotinib in Participants With Chronic Myeloid Leukemia
The purpose of this study is to compare the efficacy and safety of 2 starting doses of ponatinib compared to nilotinib in participants with imatinib-resistant chronic myeloid leukemia (CML) in chronic phase (CP).
- Trial name
- OPTIC-2L (NCT02627677)
- Testing
- Ponatinib 30 mg QD, Ponatinib 15 mg QD, Nilotinib 400 mg BID
- Where
- Belgium
- Volunteers
- 44 people
- Sponsor
- Ariad Pharmaceuticals
Chronic Myelogenous Leukemia
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase.
- Trial name
- NCT00333840
- Testing
- imatinib mesilate, interferon-alpha (INF-a), cytarabine (ARA-C)
- Where
- 163 sites in United States, Australia and 14 more
- Volunteers
- 1,106 people
- Sponsor
- Novartis Pharmaceuticals
Myelogenous Leukemia, Chronic
A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+)…
- Trial name
- ENESTnd (NCT00471497)
- Testing
- nilotinib, imatinib
- Where
- 213 sites in United States, Argentina and 33 more
- Volunteers
- 846 people
- Sponsor
- Novartis Pharmaceuticals
Psoriasis
A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
The main objective of this study is to evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis.
- Trial name
- NCT01519089
- Testing
- CP-690,550, CP-690, 550
- Where
- 16 sites in Japan
- Volunteers
- 95 people
- Sponsor
- Pfizer