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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: bevacizumab Drug: carboplatin Drug: GDC-0941 Drug: paclitaxel Drug: pemetrexed Drug: cisplatin	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Paclitaxel Carboplatin Pemetrexed Pemetrexed disodium Bevacizumab

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]
Tumor response [ Time Frame: Assessed at periodic intervals ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PK parameters of GDC-0941, paclitaxel, and carboplatin (Arms A and B); and GDC-0941, pemetrexed, and cisplatin (Arm C), (total exposure, and maximum and minimum serum concentrations) [ Time Frame: Through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Enrollment:	55
Study Start Date:	October 2009
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: carboplatin Intravenous repeating dose Drug: GDC-0941 Oral repeating dose Drug: paclitaxel Intravenous repeating dose
Experimental: B	Drug: bevacizumab Intravenous repeating dose Drug: carboplatin Intravenous repeating dose Drug: GDC-0941 Oral repeating dose Drug: paclitaxel Intravenous repeating dose
Experimental: C	Drug: bevacizumab Intravenous repeating dose Drug: GDC-0941 Oral repeating dose Drug: pemetrexed Intravenous repeating dose Drug: cisplatin Intravenous repeating dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974584

Locations

United States, New York

Buffalo, New York, United States, 14263
France

Villejuif, France, 94805
Netherlands

Groningen, Netherlands, 9700 RB

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Rainer Brachmann, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT00974584 History of Changes
Other Study ID Numbers:	GDC4628g, GO01303
Study First Received:	September 8, 2009
Last Updated:	November 21, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

NSCLC
PI3K
Avastin

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Bevacizumab
Cisplatin
Carboplatin
Paclitaxel

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013