Clinical trial NCT00975182: A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
Official title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers
Keywords: PI3K
NSCLC
Tarceva
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-11
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence, nature, and severity of adverse events
timeFrame: Through study completion or early study discontinuation
measure: Tumor response
timeFrame: Assessed at periodic intervals
Secondary outcomes:
measure: PK parameters of GDC-0941 (total exposure, and maximum and minimum serum concentrations)
timeFrame: Through study completion or early study discontinuation
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: New Brunswick
country: United States
state: New Jersey
city: Amsterdam
country: Netherlands
city: Utrecht
country: Netherlands
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: