A Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered to Patients With Refractory Solid Tumors or Lymphoma

Solid Cancers Clinical Trial

Official title:

An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of GDC-0917 Administered Daily in Patients With Refractory Solid Tumors or Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226277
• Other study ID #: 4914g
• Secondary ID: GO01306
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2010
• Last updated: November 1, 2016
• Start date: October 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, Phase I dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics (PK) of GDC-0917 in patients with refractory solid tumors or lymphoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable

• Life expectancy >/= 12 weeks

• Adequate hematologic and end organ function

• For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception and to continue its use for the duration of the study.

Exclusion Criteria:

• Clinically significant history of chronic liver disease, active hepatic infection, evidence of hepatic cirrhosis or Grade >/= 2 liver dysfunction not due to hepatic metastases of cancer, current alcohol abuse, active infections with hepatitis B virus, or hepatitis C virus

• Grade >/= 2 fever or associated constitutional symptoms, or a clinically significant systemic infection within the last month

• Autoimmune disease

• History of clinically significant pulmonary disease

• Need for chronic and continuous systemic or topical corticosteroids or immunosuppressive therapy within 2 weeks prior to study entry or anticipated need of continuous systemic corticosteroids or immunosuppressive therapy during study participation.

• Allergy or hypersensitivity to components of the GDC-0917 formulation

• Palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in Cycle 1

• Experimental therapy within 4 weeks prior to first dose of study drug treatment in Cycle 1

• Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment

• Prior anti-cancer therapy within 4 weeks before the first dose of study drug treatment in Cycle 1

• All acute drug-related toxicities must have resolved prior to study entry, except for alopecia and Grade 1 neuropathy

• Current severe, uncontrolled systemic disease excluding cancer

• History of clinically significant cardiac dysfunction

• History of malabsorption or other condition that would interfere with enteral absorption

• Any history of active GI bleeding within the past 6 months prior to screening

• Known HIV infection

• Uncontrolled ascites, due to diseases other than cancer, requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment

• Pregnancy, lactation, breastfeeding or unwillingness to use birth control during the study and for 3 months after the last dose of GDC-0917

• Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms

Study Design

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

Related Conditions & MeSH terms

• Solid Cancers

Intervention

Drug:
• GDC-0917
Oral repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in vital signs, ECGs, and clinical laboratory results		Throughout study or until early discontinuation	No
Primary	Incidence and nature of dose-limiting toxicities and adverse events of special interest		Throughout study or until early discontinuation	No
Primary	Incidence, nature, and severity of all adverse events and serious adverse events		Throughout study or until early discontinuation	No
Secondary	Pharmacokinetic parameters of GDC-0917 (including total exposure, maximum and minimum serum concentration, time to maximum observed plasma concentration, elimination of half-life, accumulation at steady-state)		Throughout study or until early discontinuation	No