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

Genentech

Status and phase

Completed

Phase 1

Conditions

Solid Tumor

Treatments

Drug: GDC-0425

Drug: gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01359696

DPM4957g

GO00767 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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