Stage 1: Solid tumors, Stage 2: Non-small cell lung cancer
Conditions
Interventions
investigational material(s)
Generic name etc : GDC-0941
INN of investigational material : pictilisib
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stage 1 -Histologically or cytologically confirmed solid tumors. -Advanced or recurrent cancer for which standard treatments are ineffectve or are not established. -ECOG PS 0 or 1. Stage 2 -Histologically or cytologically confirmed Non-squamous Non-small cell lung cancer (NSCLC). -Patients with Stage 3B or 4 NSCLC, or postoperative recurrence of NSCLC. -No history of chemotherapy for advanced or recurrent NSCLC. -ECOG PS 0 or 1.
Exclusion criteria
Exclusion criteria: Stage 1 and Stage 2 -Central nerves system metastases accompanying symptoms or requiring treatment. -Type 1 or Type 2 Diabetes requiring drug treatment. -History of treatment with PI3K inhibitor. -Current or previous radiographic evidence of Interstitial Lung Disease. Stage 2 -Current or previous hemoptysis or hemosputum. -Bleeding tendency. -Current radiographic evidence of cavitary lung lesions. -Current peripheral neuropathy of Grade >=2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1 -DLT and Adverse Event Profile -Pharmacokinetics of GDC-0941 -MTD and the recommended dose of GDC-0941 Stage 2 -DLT and Adverse Event Profile -Pharmacokinetics of GDC-0941 in combination with CP plus BEV -MTD and the recommended dose of GDC-0941 in combination with CP plus BEV CTCAE ver.4.03 | — |
Secondary
| Measure | Time frame |
|---|---|
| Stage 1 -Anti-tumor effect -Investigation of Pharmacodynamics: Inhibitory Activity of pAKT in platelet rich plasma Stage 2 -Anti-tumor effect RECIST ver.1.1 | — |
Outcome results
None listed