A Phase I, Open-label Study to Assess the Safety and Tolerability of AZD0530 in Combination With Carboplatin and/or Paclitaxel Chemotherapy in Patients With Solid Tumours
Overview
- Phase
- Phase 1
- Intervention
- AZD0530
- Conditions
- Neoplasms
- Sponsor
- AstraZeneca
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
This study will comprise 2 parts, a dose escalation phase and a dose expansion phase. The 2 phases are part of a single study and described by this single protocol. Patients entered into the dose escalation phase will not be entered into the expansion phase. All subjects must be suitable for treatment with either carboplatin and/or paclitaxel.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Life expectancy \> 12 weeks
- •Women defined as post-menopausal
- •Male or female patients with locally advanced or metastatic cancer suitable for treatment with carboplatin and/or paclitaxel
Exclusion Criteria
- •Inadequate bone marrow reserve
- •Inadequate live function, renal function or low haemoglobin
- •Unresolved toxicity from anti-cancer therapy
Arms & Interventions
1
AZD0530 + Paclitaxel
Intervention: AZD0530
1
AZD0530 + Paclitaxel
Intervention: Paclitaxel
2
AZD0530 + Carboplatin
Intervention: AZD0530
2
AZD0530 + Carboplatin
Intervention: Carboplatin
3
AZD0530 + Carboplatin + Paclitaxel
Intervention: AZD0530
3
AZD0530 + Carboplatin + Paclitaxel
Intervention: Carboplatin
3
AZD0530 + Carboplatin + Paclitaxel
Intervention: Paclitaxel
Outcomes
Primary Outcomes
To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans.
Time Frame: Assessed at each visit
Secondary Outcomes
- To determine the Maximum Tolerated Dose of AZD0530 when administered in combination with carboplatin and/or paclitaxel by assessment of safety and tolerability data generated for each treatment arm.(Assessed at each visit)
- To make a preliminary evaluation of clinical response by assessment of RECIST evaluation, time to progression and serum tumour markers.(Assessment at end of study)
- To investigate the PK of AZD0530. paclitaxel and carboplatin when co-administered to patients with solid tumours, by assessment of appropriate PK parameters.(Predetermined timepoints after dose administration)