Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918
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| ClinicalTrials.gov Identifier: NCT00733031 |
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Recruitment Status :
Terminated
(PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.)
First Posted : August 12, 2008
Last Update Posted : December 10, 2010
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Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer, Solid Tumors Advanced Solid Malignancies | Drug: AZD6918 Drug: gemcitabine Drug: pemetrexed | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 75 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6918 Administered Daily as a Single Agent and in Combination Treatment in Adult Patients With Refractory Solid Malignancies |
| Study Start Date : | August 2008 |
| Actual Primary Completion Date : | March 2009 |
| Actual Study Completion Date : | March 2009 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: gemcitabine
gemcitabine administered in combination with AZD6918
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Drug: gemcitabine
intravenous, doses are on an intermittent schedule
Other Name: Gemzar |
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Experimental: pemetrexed
pemetrexed administered in combination with AZD6918
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Drug: pemetrexed
intravenous, dose administered every 21-days
Other Name: Alimta |
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Experimental: AZD6918
AZD6918 administered alone
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Drug: AZD6918
liquid suspension, daily, oral dose |
Primary Outcome Measures :
- Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, Karnofsky performance status [ Time Frame: Weekly for first two treatment cycles, then every 2-4 weeks ]
Secondary Outcome Measures :
- Pharmacokinetic effect of AZD6918 when administered alone and in combination with chemotherapy [ Time Frame: 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Information from the National Library of Medicine
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): NCT00733031
Locations
| United States, Colorado | |
| Research Site | |
| Aurora, Colorado, United States | |
| United States, Tennessee | |
| Research Site | |
| Nashville, Tennessee, United States | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Judith Ochs, MD | AstraZeneca | |
| Principal Investigator: | Jeffrey Infante, MD | SCRI Development Innovations, LLC | |
| Principal Investigator: | Lia Gore, MD | University of Colorado, Denver |
| Responsible Party: | Judith Ochs, M.D. Medical Science Director, AstraZeneca Pharmaceuticals, LP |
| ClinicalTrials.gov Identifier: | NCT00733031 History of Changes |
| Other Study ID Numbers: |
D2785C00002 |
| First Posted: | August 12, 2008 Key Record Dates |
| Last Update Posted: | December 10, 2010 |
| Last Verified: | December 2010 |
Keywords provided by AstraZeneca:
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Phase I, cancer, solid tumors, advanced solid malignancies, |
dose escalation, combination treatment, TRK inhibitor |
Additional relevant MeSH terms:
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Neoplasms Gemcitabine Pemetrexed 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 Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |