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Completed

NCT Number: NCT01003158

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

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.

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Key information

Conditions

Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AZD8931

Drug

Tablet Oral bid

paclitaxel

Drug

IV once weekly for 3 weeks followed by a week off

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 28, 2009
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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