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An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid Tumors


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

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Trial Information

An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid Tumors


Inclusion Criteria:



- Histologically documented, incurable, locally advanced or metastatic solid tumors for
which standard therapy either does not exist or has proven ineffective or
intolerable.

- Evaluable or measurable disease

- Life expectancy >= 12 weeks

- Adequate hematologic and organ function within 14 days before initiation of GDC-0068

- Documented willingness to use an effective means of contraception (e.g., abstinence,
hormonal or double barrier method, surgically sterilized partner) for both men and
women while participating in the study

Exclusion Criteria:

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

- Grade > 2 hypercholesterolemia or hypertriglyceridemia

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

- Leptomeningeal disease as the only manifestation of the current malignancy

- Known untreated malignancies of the brain or spinal cord, or treated brain metastases
that are not radiographically stable for >= 3 months

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-0068

Outcome Time Frame:

Through study completion or early study discontinuation

Safety Issue:

No

Principal Investigator

Premal Patel, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

PAM4743g

NCT ID:

NCT01090960

Start Date:

March 2010

Completion Date:

January 2013

Related Keywords:

  • Solid Cancers

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