Small-cell lung cancer
Conditions
Interventions
Gedatolisib 145mg/body is weekly administrated until disease progression or discontinuation for adverse event.
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate by central review at the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| * Response rate (investigator review) * Disease control rate * Incidence of adverse events * Relapse-free survival * Overall survival | — |
Countries
Japan
Contacts
Public ContactSeiji,Hibiki Niho,Udagawa
National Cancer Center Hospital East Divisions of Thoracic Oncology
Outcome results
None listed