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

Sponsor

AstraZeneca (Industry)

Overall Status

Terminated

CT.gov ID

NCT00733031

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

37.5

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Solid Tumors Advanced Solid Malignancies	Drug: AZD6918 Drug: gemcitabine Drug: pemetrexed	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gemcitabine gemcitabine administered in combination with AZD6918	Drug: gemcitabine intravenous, doses are on an intermittent schedule Other Names: Gemzar
Experimental: pemetrexed pemetrexed administered in combination with AZD6918	Drug: pemetrexed intravenous, dose administered every 21-days Other Names: Alimta
Experimental: AZD6918 AZD6918 administered alone	Drug: AZD6918 liquid suspension, daily, oral dose

Arm

Intervention/Treatment

Experimental: gemcitabine

gemcitabine administered in combination with AZD6918

Drug: gemcitabine

intravenous, doses are on an intermittent schedule

Other Names:

Gemzar

Experimental: pemetrexed

pemetrexed administered in combination with AZD6918

Drug: pemetrexed

intravenous, dose administered every 21-days

Other Names:

Alimta

Experimental: AZD6918

AZD6918 administered alone

Drug: AZD6918

liquid suspension, daily, oral dose

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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