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

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Genentech

Status and phase

Completed
Phase 1

Conditions

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

Treatments

Drug: erlotinib HCl
Drug: GDC-0941

Study type

Interventional

Funder types

Industry

Identifiers

NCT00975182
GDC4626g
GO01301 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

58 participants in 1 patient group

A
Experimental group
Treatment:
Drug: GDC-0941
Drug: erlotinib HCl

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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