EUCTR2009-010551-26-HU
Active, not recruiting
Not Applicable
A Phase I/II Multi-centre Study of AZD8931 in Combination with WeeklyPaclitaxel to Assess the Safety, Tolerability, Pharmacokinetics and Efficacyin Patients with Advanced Solid Tumours and in a Selected Population withLow HER2-expressing Locally Recurrent and/or Metastatic Breast Cancer(THYME) - THYME
ConditionsPhase I part of the study: Advanced solid tumoursPhase II part of the study: Low HER2 expressing locally recurrent and/or metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10049280Term: Solid tumour
DrugsPaclitaxel
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Phase I part of the study: Advanced solid tumoursPhase II part of the study: Low HER2 expressing locally recurrent and/or metastatic breast cancer
- Sponsor
- AstraZeneca AB
- Enrollment
- 192
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients
- •1\. Provision of signed, written informed consent
- •2\. Age 18 years and older
- •3\. Radiation therapy must be terminated at least 2 weeks prior to enrolment. Patients
- •must have recovered from the toxic effects of prior therapy
- •4\. Suitable for paclitaxel therapy
- •5\. Life expectancy of more than 12 weeks
- •6\. Not previously randomised to treatment in this study
- •7\. Females of non\-childbearing status defined as one of the following criteria at
- •screening:\- negative pregnancy test in women of childbearing potential\- or women
Exclusion Criteria
- •All the points included in this section are restrictions
- •All patients
- •1\. Female patients of child bearing potential must use an acceptable highly effective
- •method of contraception during the study, and for 3 months after the last dose of IP.
- •Recommended methods of contraception are listed in Appendix J
- •2\. Patients should use sunglasses and sun cream with UVA and UVB protection
- •SPF\>15 if exposed to sunlight and avoid use of sun tanning booths during the study
- •and for 3 months after the last dose of IP
- •3\. Patients who are blood donors should not donate blood during the trial and for 3
- •months following their last dose of IP
Outcomes
Primary Outcomes
Not specified
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