UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020585
Receipt number 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 08:36:51

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



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

Value
https://center6.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