Overview

This trial is active, not recruiting.

Condition solid tumour
Treatments midazolam, dextromethorphan, gdc-0973/xl518
Phase phase 1
Sponsor Genentech
Start date April 2009
End date May 2015
Trial size 120 participants
Trial identifier NCT00467779, GO01329, MEK4592g, XL518-001

Summary

This non-randomized, open-label, study will determine the highest safe dose of GDC-0973/XL518, how often it should be taken, how well patients with cancer tolerate GDC-0973/XL518 and will assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
midazolam
In Stage III only: single dose of midazolam
dextromethorphan
In Stage III only: single dose of dextromethorphan
gdc-0973/xl518
Repeating oral dose

Primary Outcomes

Measure
Stage I-II: Safety, tolerability, and maximum tolerated dose of GDC-0973/XL518
time frame: Through study completion or early study discontinuation
Area under the concentration time curve of midazolam
time frame: Cycle 1: Days 1 and 15
Stage III: Maximum plasma concentration of dextromethorphan
time frame: Cycle 1: Days 1 and 15
Stage III: Area under the concentration time curve of dextromethorphan
time frame: Cycle 1: Days 1 and 15
Stage I-II: Maximum tolerated dose of GDC-0973
time frame: 2 years
Stage III: Maximum plasma concentration of midazolam
time frame: Cycle 1: Days 1 and 15

Secondary Outcomes

Measure
Stage I-II: Plasma pharmacokinetics and pharmacodynamic effects of GDC-0973/XL518
time frame: Through study completion or early study discontinuation
Stage III: Safety: incidence of adverse events
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival - Disease that is measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) - Adequate organ and marrow function - Sexually active patients must use medically acceptable methods of contraception during the course of the study and at least 11 days after the last dose of study treatment - Female patients of childbearing potential must have a negative serum pregnancy test at screening - No other history of/or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays Exclusion Criteria: - Anticancer treatment (e.g., chemotherapy, radiotherapy, cytokines, or hormones) within 28 days (6 weeks for nitrosoureas or mitomycin C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study drug - The patient has not recovered to Grade

Additional Information

Official title A Phase 1 Dose-Escalation Study of the Safety and Pharmacokinetics of GDC-0973/XL518 Administered Orally Daily to Subjects With Solid Tumors
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Genentech.