Study to Assess Safety of AZD7762 Administered Alone and in Combination With Gemcitabine in Patients With Advanced Solid Malignancies - Full Text View

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 Endpoint Classification: Safety Study 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:

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]


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: Gemzar® Gemcitabine HCL

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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
Health Authority:	United States: Food and Drug Administration

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 September 23, 2016