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
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ClinicalTrials.gov Identifier: NCT00974584 |
Recruitment Status :
Completed
First Posted : September 10, 2009
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
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Non-Squamous Non-Small Cell Lung Cancer | Drug: GDC-0941 Drug: bevacizumab Drug: carboplatin Drug: cisplatin Drug: paclitaxel Drug: pemetrexed | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
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Experimental: GDC-0941+Paclitaxel+Carboplatin
Bevacizumab-ineligible non-small cell lung cancer (NSCLC) participants may receive up to 6 cycles (21-day cycle) of combination chemotherapy with paclitaxel and carboplatin along with GDC-0941
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Drug: GDC-0941
The GDC-0941 at a starting dose of 60 milligrams (mg) will be administered once daily orally for 14 consecutive days (Days 1 to 14) in 3-week cycles except for the first cycle that has Day 1 of single-agent GDC-0941 preceding Day 2 with combination chemotherapy.\n\n\n\n\n\n Drug: carboplatin Carboplation IV on Day 1 of every 3-week cycle, at a dose to achieve an area under concentration time curve of 6 milligrams per milliliter*minute (mg/mL*min).\n Drug: paclitaxel Paclitaxel 200 mg/m^2 IV on Day 1 of every 3-week cycle.\n\n |
Experimental: GDC-0941+Paclitaxel+Carboplatin+Bevacizumab
Bevacizumab-eligible NSCLC particpants may receive up to 6 cycles of combination chemotherapy with paclitaxel and carboplatin along with GDC-0941 and bevacizumab.
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Drug: GDC-0941
The GDC-0941 at a starting dose of 60 milligrams (mg) will be administered once daily orally for 14 consecutive days (Days 1 to 14) in 3-week cycles except for the first cycle that has Day 1 of single-agent GDC-0941 preceding Day 2 with combination chemotherapy.\n\n\n\n\n\n Drug: bevacizumab Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle. Drug: carboplatin Carboplation IV on Day 1 of every 3-week cycle, at a dose to achieve an area under concentration time curve of 6 milligrams per milliliter*minute (mg/mL*min).\n Drug: paclitaxel Paclitaxel 200 mg/m^2 IV on Day 1 of every 3-week cycle.\n\n |
Experimental: GDC-0941+Pemetrexed+Cisplatin
Bevacizumab-ineligible NSCLC participants may receive up to 6 cycles of combination chemotherapy with pemetrexed and cisplatin along with GDC-0941.\n
|
Drug: GDC-0941
The GDC-0941 at a starting dose of 60 milligrams (mg) will be administered once daily orally for 14 consecutive days (Days 1 to 14) in 3-week cycles except for the first cycle that has Day 1 of single-agent GDC-0941 preceding Day 2 with combination chemotherapy.\n\n\n\n\n\n Drug: bevacizumab Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle. Drug: cisplatin Cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of every 3-week cycle.\n Drug: pemetrexed Pemetrexed 500 mg/m^2 IV on Day 1 of every 3-week cycle. |
Experimental: GDC-0941+Pemetrexed+Cisplatin+Bevacizumab
Bevacizumab-eligible NSCLC participants may receive up to 6 cycles of combination chemotherapy with pemetrexed and cisplatin along with GDC-0941 and bevacizumab.\n
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Drug: GDC-0941
The GDC-0941 at a starting dose of 60 milligrams (mg) will be administered once daily orally for 14 consecutive days (Days 1 to 14) in 3-week cycles except for the first cycle that has Day 1 of single-agent GDC-0941 preceding Day 2 with combination chemotherapy.\n\n\n\n\n\n Drug: bevacizumab Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle. Drug: cisplatin Cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of every 3-week cycle.\n Drug: pemetrexed Pemetrexed 500 mg/m^2 IV on Day 1 of every 3-week cycle. |
- Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Days 1 to 22 of Cycle 1 ]
- Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 5.5 years ]
- Maximum Plasma Concentration of Paclitaxel [ Time Frame: Cycle 1 Day 2: Pre-paclitaxel infusion, end of paclitaxel infusion, 0.5, 1 and 2 hours post-paclitaxel infusion; Cycle 1 Day 3: Pre-GDC-0941 dose, 24 hours post-paclitaxel Day 2 infusion ]
- Maximum Plasma Concentration of Carboplatin [ Time Frame: Cycle 1 Day 2: Pre-carboplatin infusion, end of Carboplatin infusion, 0.5, 1.5 hours post-carboplatin infusion\n\n ]
- Maximum Plasma Concentration of Pemetrexed [ Time Frame: Cycle 1 Day 2: Pre-pemetrexed infusion, end of pemetrexed infusion, 1, 3 hours post-pemetrexed infusion; Cycle 1 Day 3: Pre-GDC-0941 dose, 24 hours post-pemetrexed Day 2 infusion\n\nd be "Yes". ]
- Maximum Plasma Concentration of Cisplatin [ Time Frame: Cycle 1 Day 2: Pre-cisplatin infusion, end of cisplatin infusion, 3 hours post-cisplatin infusion; Cycle 1 Day 3: Pre-GDC-0941 dose, 24 hours post-pemetrexed Day 2 infusion\n\n ]
- Percentage of Participants with Objective Response (Complete or Partial Response), as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Screening, Days 15 to 21 of Cycles 2, 4, 6, 9, and every 3 cycles thereafter (up to approximately 5.5 years)\n\n ]
- Duration of Response, as Assessed Using RECIST\n\n\n [ Time Frame: Screening, Days 15 to 21 of Cycles 2, 4, 6, 9, and every 3 cycles thereafter (up to approximately 5.5 years) ]
- Progression-free Survival (PFS), as Assessed Using RECIST\n [ Time Frame: Screening, Days 15 to 21 of Cycles 2, 4, 6, 9, and every 3 cycles thereafter (up to approximately 5.5 years)\n\n ]
- Maximum Plasma Concentration of GDC-0941 [ Time Frame: Cycle 1 Days 1 and 2: Pre-GDC-0941 dose, 1, 2, 3 and 4 hours post-GDC-0941 dose; Cycle 1 Days 3 and 9: Pre-GDC-0941 dose; 30 days after last dose of study treatment (up to approximately 5.5 years) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974584
United States, New York | |
Buffalo, New York, United States, 14263 | |
France | |
Villejuif, France, 94805 | |
Netherlands | |
Groningen, Netherlands, 9700 RB |
Study Director: | Clinical Trials | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT00974584 |
Other Study ID Numbers: |
GDC4628g GO01303 ( Other Identifier: Hoffmann-La Roche ) |
First Posted: | September 10, 2009 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
NSCLC PI3K Avastin |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Bevacizumab Carboplatin Pemetrexed Antineoplastic Agents, Phytogenic |
Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |