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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020585
Receipt No. R000023766
Scientific Title Investigator initiated Phase II Study of Gedatolisib in Advanced Recurrent Small-Cell Lung Cancer Patients harboring Molecular Alterations in PI3K/AKT/mTOR Pathway
Date of disclosure of the study information 2016/02/01
Last modified on 2020/08/12

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Basic information
Public title Investigator initiated Phase II Study of Gedatolisib in Advanced Recurrent Small-Cell Lung Cancer Patients harboring Molecular Alterations in PI3K/AKT/mTOR Pathway
Acronym Phase II Study of Gedatolisib in Advanced Recurrent Small-Cell Lung Cancer Patients harboring Molecular Alterations in PI3K/AKT/mTOR Pathway (EAGLE-PAT)
Scientific Title Investigator initiated Phase II Study of Gedatolisib in Advanced Recurrent Small-Cell Lung Cancer Patients harboring Molecular Alterations in PI3K/AKT/mTOR Pathway
Scientific Title:Acronym Phase II Study of Gedatolisib in Advanced Recurrent Small-Cell Lung Cancer Patients harboring Molecular Alterations in PI3K/AKT/mTOR Pathway (EAGLE-PAT)
Region
Japan

Condition
Condition Small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to assess the efficacy of PF-05212384 in advanced recurrent SCLC patients harboring molecular alterations in PI3K/AKT/mTOR pathway.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate by central review at the end of study
Key secondary outcomes * Response rate (investigator review)
* Disease control rate
* Incidence of adverse events
* Relapse-free survival
* Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gedatolisib 145mg/body is weekly administrated until disease progression or discontinuation for adverse event.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Age >= 20 years.
2) Histological or cytological diagnosis of metastatic SCLC
3) Presence of PI3K/AKT/mTOR pathway alteration in tumor: harboring PIK3CA, PTEN, AKT1, TSC1, TSC2, or mTOR gene alteration.
4) Progressive disease after two or more prior chemotherapy regimens
5) ECOG performance status must be 0 to 2
6) At least one measurable lesion according to RECIST
7) Adequate organ function, including:
1. Absolute neutrophil count >= 1,500/mm3 (or >= 1.5x 109/L)
2. Hemoglobin >= 9g /dL
3. Platelets >= 100,000/mm3 (or >= 100 x 109/L)
4. Total serum bilirubin =< 1.5mg/dL
5. AST =< 100 IU/L(or U/L); =< 200 IU/L(or U/L) if there is liver involvement secondary to tumor
6. ALT =< 100 IU/L (or U/L); =< 200 IU/L (or U/L) if there is liver involvement secondary to tumor
7. Serum creatinine =< 1.5 mg/dL
8. Glucose =< 126 mg/dL and HbA1c < 7%
9. SpO2 >= 90%
10. Adequate cardiac function, including: 12 Lead ECG with normal tracing or non- clinically significant changes that do not require medical intervention, HR >= 50bpm,QTc < 480msec and no history of QT/QTc delay.
8) Resolved acute effects of any prior therapy to baseline severity or Grade 1 CTCAE.
9) Serum/urine pregnancy test negative at screening and at baseline.
10) Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment.
11)Life expectancy of at least 12 weeks
12) Written informed consent.
13) Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Key exclusion criteria 1) Patients with known active brain metastases. Patients with previously diagnosed are eligible if they have completed their CNS treatment and have recovered from radiation therapy or surgery, have discontinued corticosteroid treatment for these metastases for at least 2 weeks and are neurologically stable.
2) Chemotherapy, biological or investigational agents within 4 weeks.
3) Radiotherapy within 2 weeks.
4) Any surgery within 4 weeks or not fully recovered from any side effects of previous procedures.
5) Prior therapy with an agent that is known or proposed to be active by action on PI3K, AKT and/or mTOR
6) Known interstitial lung diseases.
7) Current or previous malignancies of other histologies within the last 3 years, other than adequately treated skin cancer except melanoma, endocervical cancer, thyroid cancer, early gastric cancer or early colorectal cancer.
8) Uncontrolled or significant cardiovascular disease:
a) A myocardial infarction, uncontrolled angina, Congestive heart failure within 6 months.
b) Diagnosed or suspected congenital long QT syndrome.
c) Any history of ventricular arrhythmias.
d) Any history of second or third degree heart block.
e) Uncontrolled hypertension.
9) Current use or anticipated need for drugs that are known as strong or middle CYP3A4 inhibitors, or CYP3A4 inducer.
10) Current or anticipated need for drugs that are known substrates of UGT1A9
11) Positive HBs antigen.
12) Clinically significant infection with bacteria, fungus or virus.
13) Breast feeding or pregnancy
14) Any mental disorder that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of the protocol.
15) Presence of well-established activating KRAS mutation or BRAF mutation (V600E) in tumor
16) Patients with any major acute or chronic medical or mental condition or laboratory abnormality that is considered to increase the risk associated with participation in the study by the investigator.
Target sample size 19

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Goto
Organization National Cancer Center Hospital East
Division name Divisions of Thoracic Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Email eagle_core@east.ncc.go.jp

Public contact
Name of contact person
1st name Seiji,Hibiki
Middle name
Last name Niho,Udagawa
Organization National Cancer Center Hospital East
Division name Divisions of Thoracic Oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Homepage URL
Email eagle_core@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of NCC
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
Tel 04-7133-1111
Email irboffice@east.ncc.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学病院(北海道)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
静岡県立静岡がんセンター(静岡県)
名古屋大学病院(愛知県)
大阪市立総合医療センター(大阪府)
四国がんセンター(愛媛県)
九州がんセンター(福岡県)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 11 Month 06 Day
Date of IRB
2015 Year 12 Month 10 Day
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 15 Day
Last modified on
2020 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023766

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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