NCT00975182

Brief Summary

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid tumors and patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

5 years

First QC Date

September 8, 2009

Last Update Submit

November 1, 2016

Conditions

Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers

Keywords

PI3KNSCLCTarceva

Outcome Measures

Primary Outcomes (2)

  • Incidence, nature, and severity of adverse events

    Through study completion or early study discontinuation

  • Tumor response

    Assessed at periodic intervals

Secondary Outcomes (1)

  • PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations)

    Through study completion or early study discontinuation

Study Arms (1)

A

EXPERIMENTAL
Drug: GDC-0941Drug: erlotinib HCl

Interventions

GDC-0941DRUG

Oral repeating dose

A
erlotinib HClDRUG

Oral repeating dose

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable (dose-escalation stage only)
  • Documented locally advanced or metastatic NSCLC in patients who have failed at least one prior chemotherapy-based regimen for incurable disease (cohort-expansion stage only)
  • Adequate organ function as assessed by laboratory tests
  • Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
  • Agreement to use an effective form of contraception for the duration of the study

You may not qualify if:

  • Any anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe prior to first study treatment
  • Prior treatment with PI3K pathway-inhibiting agents (cohort-expansion stage only)
  • History of Grade \>= 3 fasting hyperglycemia or diabetes requiring regular medication
  • Current clinically significant and uncontrolled systemic disease (e.g., cardiovascular, pulmonary, or metabolic)
  • 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
  • Active autoimmune disease and/or need for corticosteroid therapy
  • Known brain metastases that are untreated, symptomatic, or require therapy
  • Pregnancy, lactation, or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

New Brunswick, New Jersey, 08903, United States

Location

Unknown Facility

Amsterdam, 1066 EC, Netherlands

Location

Unknown Facility

Utrecht, 3508 GA, Netherlands

Location

MeSH Terms

Interventions

2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidineErlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Clinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 11, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

NL(2)US(2)