A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

Conditions

• Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GDC-0941 — DRUG
  Oral repeating dose
• erlotinib HCl — DRUG
  Oral repeating dose

Study Details

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.

Key Dates

First listed

Sep 11, 2009

Start date

Sep 30, 2009

Status verified

Nov 2016

Primary completion

Sep 30, 2014

Completion

Sep 30, 2014

Study Design

Enrollment

58 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: A

Primary Outcome Measure

Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]

Locations (2)