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

NCT00733031 | Terminated Phase 1

• 1 other identifier: D2785C00002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer,; Solid Tumors; Advanced Solid Malignancies

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (3)

gemcitabine

EXPERIMENTAL

gemcitabine administered in combination with AZD6918

Drug: gemcitabine

pemetrexed

EXPERIMENTAL

pemetrexed administered in combination with AZD6918

Drug: pemetrexed

AZD6918

EXPERIMENTAL

AZD6918 administered alone

Drug: AZD6918

Interventions

AZD6918 DRUG

liquid suspension, daily, oral dose

AZD6918

gemcitabine DRUG

intravenous, doses are on an intermittent schedule

Also known as: Gemzar

gemcitabine

pemetrexed DRUG

intravenous, dose administered every 21-days

Also known as: Alimta

pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Aurora, Colorado, United States

Location

Research Site

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Gemcitabine; Pemetrexed

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Judith Ochs, MD

  AstraZeneca

  STUDY DIRECTOR

• Jeffrey Infante, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

• Lia Gore, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 10, 2010

Record last verified: 2010-12

Locations

US (2)