Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine
This study has been terminated.
(Termination of the study was made after a full review of program data and assessment of the current risk-benefit profile.)
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00937664
First received: July 9, 2009
Last updated: February 4, 2011
Last verified: February 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer Solid Tumors Advanced Solid Malignancies |
Drug: AZD7762 Drug: gemcitabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability & Pharmacokinetics of AZD7762 Administered as a Single Intravenous Agent and in Combination w/ Wkly Standard Dose Gemcitabine in Japanese Patients w/ Advanced Solid Malignancies |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, cardiac markers, ECG, Echocardiogram [ Time Frame: Laboratory values weekly for all treatment cycles, and the other variables weekly for Cycle 0-1, then every cycle (3-4 weeks) from Cycle 2 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic effect of AZD7762 when administered alone and in combination with gemcitabine [ Time Frame: According to protocol specified schedule, the number of PK samples collected during Cycle 0 and Cycle 1 ] [ Designated as safety issue: Yes ]
- Anti-tumor activity of AZD7762 when administered in combination with gemcitabine by assessment of Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Every 2-3 cycles ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
AZD7762 + gemcitabine
AZD7762 administered alone and in combination with gemcitabine
|
Drug: AZD7762
solution, intravenous, weekly
Drug: gemcitabine
intravenous, weekly
Other Name: Gemzar
|
Eligibility| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective.
- Must be suitable for treatment with gemcitabine
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937664
Locations
| Japan | |
| Research Site | |
| Minami-ku, Fukuoka, Japan | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Peter Langmuir, MD | AstraZeneca |
| Principal Investigator: | Takashi Seto, MD, PhD | National Hospital Organization Kyushu Cancer Center |
More Information
No publications provided
| Responsible Party: | MSD, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00937664 History of Changes |
| Other Study ID Numbers: | D1040C00008 |
| Study First Received: | July 9, 2009 |
| Last Updated: | February 4, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency |
Keywords provided by AstraZeneca:
|
Phase I cancer solid tumors advanced solid malignancies |
dose escalation combination treatment CHK inhibitor Japanese |
Additional relevant MeSH terms:
|
Neoplasms Gemcitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on May 16, 2013