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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Cancers

Thank you

Trial Information

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


Inclusion Criteria:



- Histologically documented, incurable, locally advanced, or metastatic solid
malignancy that has progressed or failed to respond to at least one prior regimen.
Patients must not be candidates for regimens known to provide clinical benefit.

- Evaluable or measurable disease per RECIST

- Life expectancy of >= 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 anti-coagulants, 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

- Patients requiring any daily supplemental oxygen

- Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit
of normal (LLN) or hypercalcemia above the 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 patients 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 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 > 7 days

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0941

Outcome Time Frame:

Through study completion or early study discontinuation

Safety Issue:

No

Principal Investigator

Gallia Levy, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

GDC4255g

NCT ID:

NCT00876109

Start Date:

October 2007

Completion Date:

April 2014

Related Keywords:

  • Solid Cancers
  • Metastatic Solid Tumors
  • PI3K
  • PI3K Inhibitors

Name

Location

Phoenix, Arizona  85012
Flint, Michigan  48532
Boston, Massachusetts