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A Study of GDC-0575 Alone And in Combination With Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01564251
First received: March 23, 2012
Last updated: October 3, 2016
Last verified: October 2016
  Purpose
This open-label, multicenter, Phase I, dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of GDC-0575 administered alone or in combination with gemcitabine in patients with refractory solid tumors or lymphoma. In Stage I, cohorts of patients will receive multiple ascending oral doses of GDC-0575 alone (Arm 1) or in combination with intravenous gemcitabine (Arm 2). In Stage II, patients will receive GDC-0575 orally in combination with intravenous gemcitabine at or below the maximum tolerated dose determined in Stage I. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs, for a maximum of 17 cycles (approximately 1 year).

Condition Intervention Phase
Lymphoma, Solid Tumor
Drug: GDC-0575
Drug: gemcitabine
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel 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-0575 Administered Alone and in Combination With Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 1 year ]
  • Dose-limiting toxicities/maximum tolerated dose [ Time Frame: approximately 1 year ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre- and post-dose Days 1, 2, 3, 4, 5, 8 and 15 in Arm 1, and Days 1, 2, 8 and 9 in Arm 2 of Cycle 1 ]
  • Recommended phase II dose/schedule [ Time Frame: approximately 1 year ]

Secondary Outcome Measures:
  • Anti-tumor activity (tumor assessments according to RECIST criteria) [ Time Frame: approximately 1 year ]

Enrollment: 104
Study Start Date: March 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Monotherapy Drug: GDC-0575
multiple doses
Experimental: 2 Combination Drug: GDC-0575
multiple doses
Drug: gemcitabine
multiple doses
Experimental: Expansion Combination Drug: GDC-0575
multiple doses
Drug: gemcitabine
multiple doses

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • 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
  • Adequate hematologic, liver and renal function

Exclusion Criteria:

  • History of prior significant toxicity from a same class of agents as GDC-0575 or gemcitabine requiring discontinuation of treatment
  • All acute toxicities related to prior therapy must have resolved prior to study entry, except for alopecia and mild neuropathy
  • Current severe, uncontrolled systemic disease (including but not limited to clinically significant cardiovascular, pulmonary, or renal disease or ongoing or active infection) excluding cancer
  • History of significant cardiac dysfunction
  • History of malabsorption or other condition that would interfere with enteral absorption
  • Known HIV infection
  • Pregnancy, lactation or breastfeeding
  • Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
  • Current use of alpha-adrenergic receptor blockers
  • For Combination Arm only:

    • Any contraindication to gemcitabine therapy
    • More than two regimens of cytotoxic chemotherapy for the treatment of locally advanced or metastatic cancer
    • History of receiving high-dose chemotherapy requiring bone marrow or stem cell support
    • History of receiving radiation to more than 25% of bone marrow-bearing areas
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564251

Locations
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Tennessee
Nashville, Tennessee, United States, 37203
France
Bordeaux, France, 33076
Villejuif, France, 94805
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01564251     History of Changes
Other Study ID Numbers: GP28153 
Study First Received: March 23, 2012
Last Updated: October 3, 2016

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 23, 2017