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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01003158
First received: October 20, 2009
Last updated: June 25, 2012
Last verified: June 2012
History of Changes

October 20, 2009
June 25, 2012
October 2009
April 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Combination part: The contents of same assessment as Monotherapy. [ Time Frame: Full routine safety assessment on days 1-5, 15, 22, 28 then every 4 weeks after first dose of study drug ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01003158 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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/FMultiple dose plasma PK: AUCss0-10, AUCss0-12, Cssmax, tssmax, Cssmin, CLss/F, RAC, linearity factor) [ Time Frame: On dose Repeat Day 1 (R1) and 14 (R14): samples taken pre-dose then 1, 2, 4, 6, 8, 10, 24 (R1 only), 48 (R1 only) and 72 (R1 only) hours post dose. Repeat Day 3 (R3) and 7 (R7): pre-dose only ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study Assessing Safety and Tolerability of AZD8931 Alone or in Combination With Paclitaxel in Japanese Patients
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neoplasms
  • Metastatic Cancer
  • Breast Cancer
  • Drug: AZD8931
    Tablet Oral bid
  • Drug: Paclitaxel
    IV once weekly for 3 weeks followed by a week off
  • Experimental: Monotherapy part
    AZD8931 monotherapy
    Intervention: Drug: AZD8931
  • Experimental: Combination part
    AZD8931 plus paclitaxel
    Interventions:
    • Drug: AZD8931
    • Drug: Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
April 2012
April 2012   (final data collection date for primary outcome measure)

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)
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01003158
D0102C00010
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Mary Stuart, Dr. AstraZeneca
Principal Investigator: Takayasu Kurata, Dr. Kinki University School of Medicine
AstraZeneca
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP