Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00733031

Enrollment

Registered

2008-08-12

Start date

2008-08-31

Completion date

2009-03-31

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Malignancies, Cancer,, Solid Tumors

Keywords

Phase I,, cancer,, solid tumors,, advanced solid malignancies,, dose escalation,, combination treatment,, TRK inhibitor

Brief summary

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.

Interventions

DRUGAZD6918

liquid suspension, daily, oral dose

DRUGgemcitabine

intravenous, doses are on an intermittent schedule

DRUGpemetrexed

intravenous, dose administered every 21-days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Advanced solid tumors for which standard treatment does not exist or is no longer effective. * For chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed. * Relatively good overall health other than cancer.

Exclusion criteria

* Poor bone marrow function (not producing enough blood cells). * Poor liver or kidney function. * Serious heart conditions * History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition

Design outcomes

Primary

Measure	Time frame
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status	Weekly for first two treatment cycles, then every 2-4 weeks

Secondary

Measure	Time frame
Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy	According to protocol specified schedule, the number of PK samples collected during Cycle 1 (up to 28 days) based on treatment with AZD6918 alone or in combination with chemotherapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026