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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01226277
First received: October 20, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Solid Cancers
Drug: GDC-0917
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Changes in vital signs, ECGs, and clinical laboratory results [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
  • Incidence and nature of dose-limiting toxicities and adverse events of special interest [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]
  • Incidence, nature, and severity of all adverse events and serious adverse events [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: Throughout study or until early discontinuation ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: October 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: GDC-0917
Oral repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226277

Locations
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
San Antonio, Texas, United States, 98229
Sponsors and Collaborators
Genentech
Investigators
Study Director: Chia Portera, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01226277     History of Changes
Other Study ID Numbers: 4914g, GO01306
Study First Received: October 20, 2010
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 20, 2014