A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-11

Study Completion Date

2014-05-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

GDC-0425

Intervention Type DRUG

Oral escalating dose

gemcitabine

Intervention Type DRUG

Intravenous repeating dose

Interventions

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GDC-0425

Oral escalating dose

Intervention Type DRUG

gemcitabine

Intravenous repeating dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Pregnancy, lactation, or breastfeeding
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
* Inability to comply with study and follow up procedures

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No