Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II) (THYME)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00900627
First received: May 12, 2009
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer. This study will be conducted in 2 parts: the first part (phase I) will determine a dose of AZD8931 that can be safely administered with paclitaxel chemotherapy. The second part (phase II) will determine the efficacy and safety of AZD8931 in combination with paclitaxel chemotherapy in breast cancer.


Condition Intervention Phase
Neoplasms
Breast Neoplasms
Breast Cancer
Drug: AZD8931
Drug: Paclitaxel
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/II Multi-centre Study of AZD8931 in Combination With Weekly Paclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Solid Tumours and in a Selected Population With Low HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Phase I: To investigate the maximum tolerated dose of AZD8931 in combination with weekly paclitaxel [ Time Frame: Weekly visits for routine safety monitoring ] [ Designated as safety issue: No ]
  • Phase II: To compare the progression free survival (PFS) in patients treated with AZD8931 in combination with paclitaxel versus paclitaxel alone [ Time Frame: Tumour assessment by RECIST 1.1 every 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase II: to investigate whether there is any effect on the pharmacokinetics (PK) of AZD8931 and/or paclitaxel when co-administered [ Time Frame: Multiple PK blood samples during the first cycle of paclitaxel in combination with AZD8931 or AZD8931 placebo ] [ Designated as safety issue: No ]
  • Phase I/II: To investigate the safety and tolerability of AZD8931 in combination with paclitaxel [ Time Frame: Routine safety monitoring from consent to withdrawal ] [ Designated as safety issue: No ]
  • Phase II: To compare the objective tumour response rate in patients treated with AZD8931 in combination with paclitaxel versus paclitaxel alone [ Time Frame: Tumour assessment by RECIST 1.1 every 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: June 2009
Estimated Study Completion Date: March 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD8931 plus Paclitaxel
Drug: AZD8931
Tablet Oral bid
Drug: Paclitaxel
IV once weekly for 3 weeks followed by a week off (repeated cycles)
Other Name: Taxol
Placebo Comparator: 2
Placebo plus Paclitaxel
Drug: Paclitaxel
IV once weekly for 3 weeks followed by a week off (repeated cycles)
Other Name: Taxol
Drug: Placebo
Oral bid (twice daily)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male/ female with solid, malignant tumour which is unresponsive to standard therapies (Phase I). Female patients with advanced breast cancer with low HER2 expression (Phase II)
  • Suitable for paclitaxel chemotherapy
  • Life expectancy more than 12 weeks

Exclusion Criteria:

  • Inadequate kidney, liver, heart, gastric, lung or eye function
  • Hypersensitive to paclitaxel
  • No symptomatic uncontrolled brain metastases
  • Previous taxane chemotherapy within 12 months (Phase II)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900627

  Show 50 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Dr Serban Ghiorghiu AstraZeneca
Principal Investigator: Professor Jose Baselga Vall d'Hebron University Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00900627     History of Changes
Other Study ID Numbers: D0102C00003
Study First Received: May 12, 2009
Last Updated: March 5, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Switzerland: Swissmedic
Sweden: Medical Products Agency
Canada: Health Canada
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Bulgaria: Bulgarian Drug Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Italy: Ministry of Health
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Panama: Commemorative Institute GORGAS of Studies of Health
Panama: Ministry of Health
Brazil: National Health Surveillance Agency

Keywords provided by AstraZeneca:
Cancer
Tumour
Breast cancer
Metastatic
Secondary

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014