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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

NCT ID: NCT00974584

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Squamous Non-Small Cell Lung Cancer

Keywords

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NSCLC PI3K Avastin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

GDC-0941

Intervention Type DRUG

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

carboplatin

Intervention Type DRUG

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

paclitaxel

Intervention Type DRUG

Paclitaxel 200 mg/m\^2 IV on Day 1 of every 3-week cycle.\\n\\n

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.

Group Type EXPERIMENTAL

GDC-0941

Intervention Type DRUG

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

bevacizumab

Intervention Type DRUG

Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle.

carboplatin

Intervention Type DRUG

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

paclitaxel

Intervention Type DRUG

Paclitaxel 200 mg/m\^2 IV on Day 1 of every 3-week cycle.\\n\\n

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

Group Type EXPERIMENTAL

GDC-0941

Intervention Type DRUG

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

bevacizumab

Intervention Type DRUG

Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle.

cisplatin

Intervention Type DRUG

Cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of every 3-week cycle.\\n

pemetrexed

Intervention Type DRUG

Pemetrexed 500 mg/m\^2 IV on Day 1 of every 3-week cycle.

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

Group Type EXPERIMENTAL

GDC-0941

Intervention Type DRUG

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

bevacizumab

Intervention Type DRUG

Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle.

cisplatin

Intervention Type DRUG

Cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of every 3-week cycle.\\n

pemetrexed

Intervention Type DRUG

Pemetrexed 500 mg/m\^2 IV on Day 1 of every 3-week cycle.

Interventions

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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

Intervention Type DRUG

bevacizumab

Bevacizumab 15 milligrams per kilograms (mg/kg) intravenously (IV) on Day 1 of every 3-week cycle.

Intervention Type 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

Intervention Type DRUG

cisplatin

Cisplatin 75 milligrams per square meter (mg/m\^2) IV on Day 1 of every 3-week cycle.\\n

Intervention Type DRUG

paclitaxel

Paclitaxel 200 mg/m\^2 IV on Day 1 of every 3-week cycle.\\n\\n

Intervention Type DRUG

pemetrexed

Pemetrexed 500 mg/m\^2 IV on Day 1 of every 3-week cycle.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Buffalo, New York, United States

Site Status

Villejuif, , France

Site Status

Groningen, , Netherlands

Site Status

Countries

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United States France Netherlands

Other Identifiers

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GO01303

Identifier Type: OTHER

Identifier Source: secondary_id

GDC4628g

Identifier Type: -

Identifier Source: org_study_id