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Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918 | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

NCT00733031•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (2)

Research Site

Aurora, Colorado, United States

Research Site

Nashville, Tennessee, United States

Key Dates

Start Date

August 1, 2008

Primary Completion Date

March 1, 2009

Completion Date

March 1, 2009

Last Updated

December 10, 2010

Enrollment

ESTIMATED participants

Conditions

Cancer,Solid TumorsAdvanced Solid Malignancies

Interventions

AZD6918

DRUG

gemcitabine

DRUG

pemetrexed

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

View study

RECRUITINGNA

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

NCT06658951

HER2-positive Advanced Malignant Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors

A Study of ASP1002 in Adults for Treatment of Solid Tumors

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC