Clinical Trials/NCT01359696

NCT01359696

Completed

Phase 1

An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0425 Administered With and Without Gemcitabine in Patients With Refractory Solid Tumors or Lymphoma

Genentech, Inc.3 sites in 2 countries40 target enrollmentJuly 11, 2011

ConditionsSolid Tumor

InterventionsGDC-0425 gemcitabine

DrugsGDC-0425 gemcitabine

Overview

Phase: Phase 1
Intervention: GDC-0425
Conditions: Solid Tumor
Sponsor: Genentech, Inc.
Enrollment: 40
Locations: 3
Primary Endpoint: Incidence of all adverse events graded according to NCI CTCAE, v4.0
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 11, 2011

End Date

May 29, 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

A

Intervention: GDC-0425

A

Intervention: gemcitabine

Outcomes

Primary Outcomes

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

Time Frame: Up to 1 year

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

Time Frame: Up to 12 months or early study discontinuation

Pharmacokinetic property of GDC-0425: exposure

Time Frame: Up to 12 months or early study discontinuation

Pharmacokinetic property of GDC-0425: half-life

Time Frame: Up to 12 months or early study discontinuation

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

Time Frame: Up to 1 year

Incidence of dose limiting toxicities (DLTs)

Time Frame: Up to 35 days

Secondary Outcomes

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)