A Study of GDC-0941 in Participants With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:October 2007
End Date:November 2013

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An Open-Label, Phase I, Dose-Escalation Study Evaluating Two Dosing Schedules of PI3-Kinase Inhibitor (GDC-0941) in Patients With Locally Advanced or Metastatic Solid Tumors for Which Standard Therapy Either Does Not Exist or Has Proven Ineffective or Intolerable

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety,
tolerability, and pharmacokinetics of orally administered GDC-0941 administered once daily
(QD) and twice daily (BID) in the treatment of advanced or metastatic solid tumors.


Inclusion Criteria:

- Participants with histologically documented, incurable, locally advanced or
metastatic solid malignancy that has progressed or failed to respond to at least one
prior regimen, and who are not candidates for regimens known to provide clinical
benefit

- Evaluable or measurable disease per RECIST

- Life expectancy of greater than or equal to (>/=) 12 weeks

- Documented willingness to use an effective means of contraception (for both men and
women) while participating in the study

Exclusion Criteria:

- Leptomeningeal disease as the only manifestation of the current malignancy

- History of Type 1 or 2 diabetes mellitus requiring regular medication

- Any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytics

- Malabsorption syndrome or other condition that would interfere with enteral
absorption

- Known untreated central nervous system (CNS) malignancies or treated brain metastases
that are not radiographically stable for >/=3 months

- Active congestive heart failure or ventricular arrhythmia requiring medication

- Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive
weeks prior to enrollment

- Active infection requiring intravenous (IV) antibiotics

- Requirement for any daily supplemental oxygen

- Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit
of normal (LLN), or hypercalcemia above the upper limit of normal (ULN) for the
institution despite adequate electrolyte supplementation or management

- Clinically significant history of liver disease, including viral or other hepatitis,
current alcohol abuse, or cirrhosis

- Known human immunodeficiency virus (HIV) infection

- Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic
dysfunction, physical examination finding, or clinical laboratory finding giving
reasonable suspicion of a disease or condition that contraindicates the use of an
investigational drug or that may affect the interpretation of the results or renders
the participant at high risk from treatment complications

- Significant traumatic injury within 3 weeks before Day 1

- Major surgical procedure within 4 weeks prior to initiation of study treatment

- Treatment with chemotherapy, hormonal therapy (except gonadotropin releasing hormone
[GnRH] agonists or antagonists for prostate cancer), immunotherapy, biologic therapy,
or radiation therapy (except palliative radiation to bony metastases) as cancer
therapy within 4 weeks prior to initiation of study treatment

- Palliative radiation to bony metastases within 2 weeks prior to initiation of study
treatment

- Need for chronic corticosteroid therapy for greater than (>) 7 days
We found this trial at
3
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Boston, MA
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