Overview

This trial is active, not recruiting.

Condition lymphoma, solid tumor
Treatments gdc-0575, gemcitabine
Phase phase 1
Targets ChK1, BTK
Sponsor Genentech, Inc.
Start date March 2012
End date June 2017
Trial size 104 participants
Trial identifier NCT01564251, GP28153

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
gdc-0575
multiple doses
(Experimental)
gdc-0575
multiple doses
gemcitabine
multiple doses
(Experimental)
gdc-0575
multiple doses
gemcitabine
multiple doses

Primary Outcomes

Measure
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 Outcomes

Measure
Anti-tumor activity (tumor assessments according to RECIST criteria)
time frame: approximately 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Genentech, Inc..