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



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:October 2009
End Date:March 2015

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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 with one of three
planned regimens: Arm A: paclitaxel and carboplatin in bevacizumab-ineligible NSCLC
patients, Arm B: paclitaxel, carboplatin, and bevacizumab in bevacizumab-eligible NSCLC
patients and Arm C: pemetrexed, cisplatin, and bevacizumab in bevacizumab-eligible,
non-squamous NSCLC patients.


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
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