A Study Evaluating the Safety and Tolerability of GDC-0068 in Patients With Refractory Solid Tumors

Solid Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090960
• Other study ID #: PAM4743g
• Secondary ID: GO013352009-0150
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2010
• Last updated: July 1, 2016
• Start date: March 2010
• Est. completion date: February 2015

Study information

• Verified date: July 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of GDC-0068 administered to patients with incurable, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen or for which there is no standard therapy. This study is expected to enroll approximately 39 to 57 patients at approximately two sites in Spain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Solid Cancers

Intervention

Drug:
• GDC-0068
Oral repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events by NCI CTCAE grade and associated dose of GDC-0068		Through study completion or early study discontinuation	No
Primary	Occurrence of dose-limiting toxicities (DLTs) by NCI CTCAE grade and associated dose of GDC-0068		Through study completion or early study discontinuation	No
Primary	Occurrence of Grade 3 or 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0068		Through study completion or early study discontinuation	No
Primary	PK parameters after single and multiple doses of GDC-0068		Through study completion or early study discontinuation	No
Secondary	Best overall response, duration of objective response, and progression-free survival (PFS) for patients with measurable disease according to RECIST		Through study completion or early study discontinuation	No