Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies
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ClinicalTrials.gov Identifier: NCT00413686 |
Recruitment Status
:
Completed
First Posted
: December 20, 2006
Last Update Posted
: December 6, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors | Drug: AZD7762 Drug: Gemcitabine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
AZD7762 monotherapy followed by AZD7762 + gemcitabine
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Drug: AZD7762
intravenous infusion
Drug: Gemcitabine
weekly intravenous infusion
Other Names:
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- To assess the safety and tolerability of AZD7762 alone and in combination with Gemcitabine [ Time Frame: Assessed after each course of treatment ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413686
United States, Maryland | |
Research Site | |
Baltimore, Maryland, United States | |
United States, Michigan | |
Research Site | |
Detroit, Michigan, United States |
Study Director: | Peter Langmuir, M.D. | AstraZeneca |
Responsible Party: | MSD, AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00413686 History of Changes |
Other Study ID Numbers: |
D1040C00002 |
First Posted: | December 20, 2006 Key Record Dates |
Last Update Posted: | December 6, 2010 |
Last Verified: | December 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 |