Trial record 1 of 1 for:    NCT00974584
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00974584
First received: September 8, 2009
Last updated: July 7, 2014
Last verified: July 2014
  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 w ith one of three planned regimens: Arm A: paclitaxel and carboplatin in bevacizu mab-ineligible NSCLC patients, Arm B: paclitaxel, carboplatin, and bevacizumab i n bevacizumab-eligible NSCLC patients and Arm C: pemetrexed, cisplatin, and beva cizumab 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:


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: 65
Study Start Date: October 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: C Drug: bevacizumab
Intravenous repeating dose
Drug: GDC-0941
Oral repeating dose
Drug: pemetrexed
Intravenous repeating dose
Drug: cisplatin
Intravenous repeating dose
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 9713 GZ
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials 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: July 7, 2014
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 July 22, 2014