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Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00413686
First received: December 19, 2006
Last updated: December 3, 2010
Last verified: December 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Solid Tumors | Drug: AZD7762 Drug: Gemcitabine | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine [ Time Frame: Assessed after each course of treatment ]
Secondary Outcome Measures:
- To determine the single-dose (after the first single-agent dose) and combination-dose (afer the 2nd combination dose) pharmacokinetics (PK) of AZD7762. [ Time Frame: Assessed after each course of treatment ]
| Enrollment: | 42 |
| Study Start Date: | December 2006 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
AZD7762 monotherapy followed by AZD7762 + gemcitabine
|
Drug: AZD7762
intravenous infusion
Drug: Gemcitabine
weekly intravenous infusion
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413686
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413686
Locations
| United States, Maryland | |
| Research Site | |
| Baltimore, Maryland, United States | |
| United States, Michigan | |
| Research Site | |
| Detroit, Michigan, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Peter Langmuir, M.D. | AstraZeneca |
More Information
| Responsible Party: | MSD, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00413686 History of Changes |
| Other Study ID Numbers: |
D1040C00002 |
| Study First Received: | December 19, 2006 |
| Last Updated: | December 3, 2010 |
Keywords provided by AstraZeneca:
|
Mixed solid tumors |
Additional relevant MeSH terms:
|
Gemcitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents |
Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017