NCT01359696

Brief Summary

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GDC-0425 administered with and without gemcitabine.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2011

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 11, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2014

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

May 23, 2011

Last Update Submit

April 11, 2017

Conditions

Solid Tumor

Keywords

solid cancers

Outcome Measures

Primary Outcomes (6)

  • Incidence of all adverse events graded according to NCI CTCAE, v4.0

    Up to 1 year

  • Incidence of dose limiting toxicities (DLTs)

    Up to 35 days

  • Pharmacokinetic property of GDC-0425: determination of plasma drug concentration

    Up to 12 months or early study discontinuation

  • Pharmacokinetic property of GDC-0425: exposure

    Up to 12 months or early study discontinuation

  • Pharmacokinetic property of GDC-0425: half-life

    Up to 12 months or early study discontinuation

  • Severity of all adverse events graded according to NCI CTCAE, v4.0

    Up to 1 year

Secondary Outcomes (1)

  • Antitumor activity of GDC-0425 in combination with gemcitabine: determination of tumor response using RECIST v1.1 for patients with measurable disease

    Up to 12 months or early study discontinuation

Study Arms (1)

A

EXPERIMENTAL
Drug: GDC-0425Drug: gemcitabine

Interventions

GDC-0425DRUG

Oral escalating dose

A
gemcitabineDRUG

Intravenous repeating dose

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  • Signed Informed Consent Form
  • 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 and end-organ (liver and kidney) function
  • For female patients of childbearing potential and male patients with partners of childbearing potential, agreement by the patient that the patient and/or partner will use an effective form of contraception
  • Patients enrolled in certain phases must be willing to provide fresh and/or archival tumor samples

You may not qualify if:

  • History of prior significant toxicity from a same class of agents as GDC-0425 or gemcitabine requiring discontinuation of treatment
  • Allergy, hypersensitivity or contraindication to the GDC-0425 formulation or gemcitabine
  • Experimental therapy or anti-cancer therapy within 4 weeks prior to the first dose of study drug treatment
  • Radiotherapy within 2 weeks prior to first dose of study drug treatment
  • 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
  • Acute drug-related toxicities from previous therapies have not 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
  • Significant heart disease and heart dysfunction including but not limited to uncontrolled severe hypertension, heart failure, and reduced cardiac contractility
  • Uncontrolled ascites, due to diseases other than cancer
  • Inability or unwillingness to swallow pills/capsules
  • History of malabsorption or other condition that would interfere with drug absorption
  • Any history of active stomach and/or intestine bleeding within the 6 months prior to screening
  • Known HIV infection
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Karmanos Cancer Institute..

Detroit, Michigan, 48201, United States

Location

Sarah Cannon Cancer Center

Nashville, Tennessee, 37203, United States

Location

Institut Gustave Roussy; Ser. de Med. Nucleaire; Cancerologie Endo

Villejuif, 94805, France

Location

MeSH Terms

Interventions

GDC-0425Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Chia Portera, M.D., Ph.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 25, 2011

Study Start

July 11, 2011

Primary Completion

May 29, 2014

Study Completion

May 29, 2014

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

US(2)FR(1)