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 |
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.
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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