Study Assessing Safety and Tolerability of AZD8931 Alone or in Combination With Paclitaxel in Japanese Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003158
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : July 10, 2014
Information provided by (Responsible Party):

Brief Summary:
The main purpose of this study is to determine if AZD8931 can be safely administered in Japanese patients alone and in combination with weekly paclitaxel. The study will be conducted in two parts: a monotherapy and a combination part, where safe doses of study treatment will be determined.

Condition or disease Intervention/treatment Phase
Neoplasms Metastatic Cancer Breast Cancer Drug: AZD8931 Drug: Paclitaxel Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Multiple-dose, Dose-escalation Study To Assess the Safety and Tolerability of AZD8931 Monotherapy in Japanese Patients With Advanced Solid Malignancies and in Combination With Paclitaxel in Japanese Female Patients With Advanced Breast Cancer
Study Start Date : October 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Monotherapy part
AZD8931 monotherapy
Drug: AZD8931
Tablet Oral bid
Experimental: Combination part
AZD8931 plus paclitaxel
Drug: AZD8931
Tablet Oral bid
Drug: Paclitaxel
IV once weekly for 3 weeks followed by a week off

Primary Outcome Measures :
  1. Monotherapy part: Assessment of adverse events, laboratory findings, physical examination, vital signs, ECG/UCG, chest X-ray, HRCT, SpO2 and ophthalmological examinations. [ Time Frame: Full routine safety assessment on days 1-4, 8, 10, 14, 21, 28 then every 3 weeks after first dose of study drug ]
  2. Combination part: The contents of same assessment as Monotherapy. [ Time Frame: Full routine safety assessment on days 1-5, 8, 15, 22, 28 then every 4 weeks after first dose of study drug ]

Secondary Outcome Measures :
  1. Combination Part: Pharmacokinetics of AZD8931 (tmax, Cmax, AUC0-10) [ Time Frame: On Day D7 and Day D8: pre-dose then, 1, 2, 4, 6, 8 and 10 hours post dose ]
  2. Combination Part: Pharmacokinetics of paclitaxel (tmax, Cmax, AUC0-10) [ Time Frame: On Days D1 and Day D8: pre-infusion then, 0.5, 1, 1.5, 2, 4, 6, 8, 10 and 24 (D1 only) hours post start of infusion ]
  3. Monotherapy Part: Pharmacokinetics of AZD8931 (Single dose plasma PK: AUC0-10, AUC0-12, AUC0-24, AUC0-t, AUC, Cmax, tmax, t1/2, CL/F, Vss/F. Multiple dose plasma PK: AUCss0-10, AUCss0-12, Cssmax, tssmax, Cssmin, CLss/F, RAC, linearity factor) [ Time Frame: On single dose Day 1 (D1) and multiple dose Day 21 (R14): samples taken pre-dose then 1, 2, 4, 6, 8, 10, 24 (D1 only), 48 (D1 only) and 72 (D1 only) hours post dose. Day 10 (R3) and Day 14 (R7): pre-dose only ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cancer that is refractory to standard therapies, or for which no standard therapies exist (monotherapy part)
  • Patients suitable for Paclitaxel chemotherapy, who are not candidates for hormonal and anthracycline therapy (combination part)
  • Life expectancy more than 12 weeks

Exclusion Criteria:

  • Inadequate kidney, liver, heart, gastric, lung or eye function
  • Brain metastases
  • Hypersensitive to paclitaxel (combination part)

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 identifier (NCT number): NCT01003158

Research Site
Osaka, Japan
Sponsors and Collaborators
Study Director: Mary Stuart, Dr. AstraZeneca
Principal Investigator: Takayasu Kurata, Dr. Kinki University School of Medicine

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT01003158     History of Changes
Other Study ID Numbers: D0102C00010
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014

Keywords provided by AstraZeneca:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action