Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies
A Phase I Open Label Multi Center Dose Escalation Study to Assess Safety, Tolerability, and Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination With Weekly Standard Dose Gemcitabine in Patients With Advanced Solid Malignancies
1 other identifier
interventional
42
1 country
2
Brief Summary
This is an open-label, multi-center, dose-escalation, Phase I study to evaluate the safety, tolerability, and pharmacokinetics and to investigate biomarker changes of AZD7762 administered as a single intravenous unit and in combination with gemcitabine. The study is sponsored by AstraZeneca.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2006
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 19, 2006
CompletedFirst Posted
Study publicly available on registry
December 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedDecember 6, 2010
December 1, 2010
3.4 years
December 19, 2006
December 3, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine
Assessed after each course of treatment
Secondary Outcomes (1)
To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762.
Assessed after each course of treatment
Study Arms (1)
1
EXPERIMENTALAZD7762 monotherapy followed by AZD7762 + gemcitabine
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- ECOG performance status of 0 or 1
- Patient and tumor type must be suitable for treatment with weekly standard gemcitabine.
You may not qualify if:
- Inadequate bone marrow reserve, inadequate liver function or impaired renal function
- Any troponin elevation (above normal range)
- Stage II, III, or IV cardiac status, according to New York Heart Association (NYHA) classification; recent history (ie, within 6 months) of coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infarction \[MI\])
- Any prior anthracycline treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Baltimore, Maryland, United States
Research Site
Detroit, Michigan, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter Langmuir, M.D.
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 19, 2006
First Posted
December 20, 2006
Study Start
December 1, 2006
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
December 6, 2010
Record last verified: 2010-12