Trial record 1 of 1 for:    NCT00974584
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A Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00974584
First received: September 8, 2009
Last updated: September 22, 2014
Last verified: September 2014

September 8, 2009
September 22, 2014
October 2009
August 2013   (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 NCT00974584 on ClinicalTrials.gov Archive Site
PK parameters of GDC-0941, paclitaxel, and carboplatin (Arms A and B); and GDC-0941, pemetrexed, and cisplatin (Arm C), (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, paclitaxel, and carboplatin (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 PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non Small Cell Lung Cancer
A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non Small Cell Lung Cancer

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered w ith one of three planned regimens: Arm A: paclitaxel and carboplatin in bevacizu mab-ineligible NSCLC patients, Arm B: paclitaxel, carboplatin, and bevacizumab i n bevacizumab-eligible NSCLC patients and Arm C: pemetrexed, cisplatin, and beva cizumab in bevacizumab-eligible, non-squamous NSCLC patients.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: GDC-0941
    Oral repeating dose
  • Drug: bevacizumab
    Intravenous repeating dose
  • Drug: carboplatin
    Intravenous repeating dose
  • Drug: cisplatin
    Intravenous repeating dose
  • Drug: paclitaxel
    Intravenous repeating dose
  • Drug: pemetrexed
    Intravenous repeating dose
  • Experimental: A
    Interventions:
    • Drug: GDC-0941
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: B
    Interventions:
    • Drug: GDC-0941
    • Drug: bevacizumab
    • Drug: carboplatin
    • Drug: paclitaxel
  • Experimental: C
    Interventions:
    • Drug: GDC-0941
    • Drug: bevacizumab
    • Drug: cisplatin
    • Drug: pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically documented NSCLC with advanced disease (Stage IIIb not eligible for chemoradiotherapy or Stage IV or recurrent disease)
  • Adequate organ function as assessed by laboratory tests
  • Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

  • More than one anti-cancer regimen (chemotherapy or radiotherapy) for advanced NSCLC prior to initiation of study treatment
  • Any adjuvant or neoadjuvant anti-cancer therapy within a specified timeframe prior to first study treatment
  • History of Grade >= 3 fasting hyperglycemia or diabetes requiring regular medication
  • Active autoimmune disease, active infection requiring IV antibiotics, or other current uncontrolled illness
  • 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
  • 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,   France,   Netherlands
 
NCT00974584
GDC4628g, GO01303
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
September 2014

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