Safety and tolerability of the Traditional Chinese Medicine Formulation GOPAC in patients with advanced malignancy
Phase 1
Withdrawn
- Conditions
- Advanced malignancy (palliative)Cancer - Other cancer types
- Registration Number
- ACTRN12609000652279
- Lead Sponsor
- Sydney South West Area Health Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
* Active malignancy (recurrent or metastatic)
* can swallow capsules WHOLE
* Fluent english or chinese
* not currently receiving chemotherapy
Exclusion Criteria
Inadequate organ function
Allergy to study ingredients (esp. mushrooms)
Eastern Cooperative Oncology performance group (ECOG PS) > 3
Concurrent radiotherapy
Major comorbidities
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: safety, as measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE V4.0)[Phase I: weekly measurements of adverse events (by NCI CTCAE V4.0) and bloods <br>for 6 weeks of active therapy; then fortnightly for another 4 weeks]
- Secondary Outcome Measures
Name Time Method Phase I: <br>* patient tolerance (as measured by pill count, physician assessment)<br>* maximum tolerated dose (measured by dose limiting toxicity)[Phase I: end of 6 weeks of active therapy]