Phase I Study of GDC-0941

Phase 1

• Conditions: Stage 1: Solid tumors, Stage 2: Non-small cell lung cancer

• Registration Number: JPRN-jRCT2080222116
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 19

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified