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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00975182
First received: September 8, 2009
Last updated: October 14, 2014
Last verified: October 2014

September 8, 2009
October 14, 2014
September 2009
August 2014   (final data collection date for primary outcome measure)
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • Tumor response [ Time Frame: Assessed at periodic intervals ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
  • Tumor response [ Time Frame: Assessed at periodic intervals ]
Complete list of historical versions of study NCT00975182 on ClinicalTrials.gov Archive Site
PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations) [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations) [ Time Frame: Through study completion or early study discontinuation ]
Not Provided
Not Provided
 
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

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administe red 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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer, Solid Cancers
  • Drug: GDC-0941
    Oral repeating dose
  • Drug: erlotinib HCl
    Oral repeating dose
Experimental: A
Interventions:
  • Drug: GDC-0941
  • Drug: erlotinib HCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands
 
NCT00975182
GDC4626g, GO01301
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP