Unique ID issued by UMIN | UMIN000020585 |
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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 |
Investigator initiated Phase II Study of Gedatolisib in Advanced Recurrent Small-Cell Lung Cancer Patients harboring Molecular Alterations in PI3K/AKT/mTOR Pathway
Phase II Study of Gedatolisib in Advanced Recurrent Small-Cell Lung Cancer Patients harboring Molecular Alterations in PI3K/AKT/mTOR Pathway (EAGLE-PAT)
Investigator initiated Phase II Study of Gedatolisib in Advanced Recurrent Small-Cell Lung Cancer Patients harboring Molecular Alterations in PI3K/AKT/mTOR Pathway
Phase II Study of Gedatolisib in Advanced Recurrent Small-Cell Lung Cancer Patients harboring Molecular Alterations in PI3K/AKT/mTOR Pathway (EAGLE-PAT)
Japan |
Small-cell lung cancer
Pneumology |
Malignancy
YES
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.
Efficacy
Response rate by central review at the end of study
* Response rate (investigator review)
* Disease control rate
* Incidence of adverse events
* Relapse-free survival
* Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Gedatolisib 145mg/body is weekly administrated until disease progression or discontinuation for adverse event.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
19
1st name | Koichi |
Middle name | |
Last name | Goto |
National Cancer Center Hospital East
Divisions of Thoracic Oncology
277-8577
6-5-1, Kashiwanoha, Kashiwa, Chiba
04-7133-1111
eagle_core@east.ncc.go.jp
1st name | Seiji,Hibiki |
Middle name | |
Last name | Niho,Udagawa |
National Cancer Center Hospital East
Divisions of Thoracic Oncology
277-8577
6-5-1, Kashiwanoha, Kashiwa, Chiba
04-7133-1111
eagle_core@east.ncc.go.jp
National Cancer Center Hospital East
Japan Agency for Medical Research and Development
Japanese Governmental office
IRB of NCC
6-5-1, Kashiwanoha, Kashiwa, Chiba
04-7133-1111
irboffice@east.ncc.go.jp
NO
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)
2016 | Year | 02 | Month | 01 | Day |
Unpublished
Terminated
2015 | Year | 11 | Month | 06 | Day |
2015 | Year | 12 | Month | 10 | Day |
2016 | Year | 03 | Month | 01 | Day |
2021 | Year | 03 | Month | 31 | Day |
2016 | Year | 01 | Month | 15 | Day |
2020 | Year | 08 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023766
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