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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence, nature, and severity of adverse events

Outcome Time Frame:

Through study completion or early study discontinuation

Safety Issue:

No

Principal Investigator

Rainer Brachmann, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GDC4628g

NCT ID:

NCT00974584

Start Date:

October 2009

Completion Date:

September 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • PI3K
  • Avastin
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Albany, New York  12208