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

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00975182

Enrollment

Registered

2009-09-11

Start date

2009-09-30

Completion date

2014-09-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

PI3K, NSCLC, Tarceva

Brief summary

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.

Interventions

DRUGGDC-0941

Oral repeating dose

DRUGerlotinib HCl

Oral repeating dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only) * Documented locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only) * Adequate organ function as assessed by laboratory tests * Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST) * Agreement to use an effective form of contraception for the duration of the study

Exclusion criteria

* Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment * Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only) * History of Grade \>= 3 fasting hyperglycemia or diabetes requiring regular medication * Current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic) * History of clinically significant cardiac or pulmonary dysfunction * History of malabsorption syndrome or other condition that would interfere with enteral absorption * Clinically significant history of liver disease * Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents * Active autoimmune disease and/or need for corticosteroid therapy * Known brain metastases that are untreated, symptomatic, or require therapy * Pregnancy, lactation, or breastfeeding

Design outcomes

Primary

Measure	Time frame
Incidence, nature, and severity of adverse events	Through study completion or early study discontinuation
Tumor response	Assessed at periodic intervals

Secondary

Measure	Time frame
PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations)	Through study completion or early study discontinuation

Countries

Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026