Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Analgesics

Amino Acids

Etoposide

Cytarabine

Mitoxantrone

Fludarabine

Fludarabine phosphate

Lenograstim

Etoposide phosphate

Idarubicin

Quizartinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Participants who were randomized to receive 20 or 30 mg quizartinib tablets administered orally once daily.

Participants who were randomized to receive salvage chemotherapy, such as low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA), were administered during 28-day cycles.

20 or 30 mg quizartinib tablets administered orally once daily

Low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA) administered during 28-day cycles

Salvage Chemotherapy

Jorge E. Cortes, MD

Global Clinical Leader

The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.

(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive

A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Overall Survival is defined as the time (in weeks) from the date of randomization to the date of death due to any cause. Median and quartiles are calculated using the Kaplan-Meier method.

Event-free survival is defined as the time (in weeks) from randomization until documented refractory disease, relapse after complete composite remission (CRc), or death from any cause, whichever is observed first.

Daiichi Sankyo

Differences in treatment regimens make the Treatment-emergent adverse events (TEAE) collection period span multiple 28-day cycles in the Quizartinib arm and only 1-2 weeks in the salvage chemotherapy arm.

Participants who were randomized to receive 20 or 30 mg Quizartinib tablets administered orally once daily.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Singapore

Hong Kong

Hungary

United States

Czechia

United Kingdom

Spain

Canada

Netherlands

South Korea

Belgium

Taiwan

Poland

Italy

Australia

France

Serbia

Germany

Region of Enrollment

Participants received standard of care salvage chemotherapy (administered subcutaneously \[LoDac\] or intravenously \[MEC and FLAG-IDA\]).

Stratified analysis - stratification factors include prior therapy and response (Relapsed in ≤6 months (not post-HSCT), Refractory, or relapsed in ≤6 months post allogeneic HSCT), and pre-selected chemotherapy (High intensity chemotherapy \[MEC or FLAG-IDA\], or low intensity chemotherapy \[LoDAC\]).

Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy

Event-free survival was assessed in the intent-to-treat (ITT) analysis set.

Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy

Overall Study

Symptoms and General Pathology

Carcinoma

Recurrence

Neoplasms, Glandular and Epithelial

Biliary Tract Cancer

Gallbladder Cancer

Gemcitabine

Cisplatin

Antimetabolites

Run-In: Selumetinib, orally, BID for 7 days (Day -7 to Day -1)

On treatment: Selumetinib, orally, BID from Day 1-21 of every 28 day cycle. Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.

Run-In: Selumetinib, orally, BID for 5 days (Day -7 to Day -3) with 2 days washout

On treatment: Selumetinib, orally, BID from Day 1-5 and 8-19 of every 28 day cycle.

Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.

Cisplatin/gemcitabine, intravenously, on Days 1 and 8 of every 28 day cycle.

Selumetinib

Jennifer Knox, M.D.

This is a phase II study (the second stage of testing a new drug or new drug combinations) to see how useful two different schedules of study drug selumetinib with cisplatin and gemcitabine are compared to cisplatin and gemticabine alone in patients with biliary cancer.

Selumetinib, an oral drug which plays an important role in the regulation of cell growth (MEK 1/2 inhibitor) has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. Selumetinib has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary tract cancer. Cisplatin and gemcitabine are intravenous drugs that work by damaging DNA in tumor cells so that they are unable to grow and divide.

A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer

A Randomized Phase II Trial of MEK Inhibitor Selumetinib (AZD6244) Combined Continuously or Sequentially With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Patients With Advanced Biliary Cancer

Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

University Health Network, Toronto

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive	NCT02039726	AML	Quizartinib Salvage Chemoth...	18 Years -	Daiichi Sankyo
A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer	NCT02151084	Biliary Tract C... Gallbladder Car...	Selumetinib Cisplatin Gemcitabine	18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for tablets

Every month we try and update this database with for tablets cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tablets

Every month we try and update this database with for tablets cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tablets cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.