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Completed

NCT Number: NCT01226277

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nashville, Tennessee, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GDC-0917

Drug

Oral repeating dose

Primary outcomes

  1. Changes in vital signs, ECGs, and clinical laboratory results

    Time frame: Throughout study or until early discontinuation

  2. Incidence and nature of dose-limiting toxicities and adverse events of special interest

    Time frame: Throughout study or until early discontinuation

  3. Incidence, nature, and severity of all adverse events and serious adverse events

    Time frame: Throughout study or until early discontinuation

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 22, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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