Phase I Study in Patients With Solid Tumours

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: AZD0530
* Drug: Carboplatin
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD0530 + Paclitaxel | Drug: AZD0530<br>* oral tablet<br>Drug: Paclitaxel<br>* intravenous infusion<br>|
| Experimental: 2<br>AZD0530 + Carboplatin | Drug: AZD0530<br>* oral tablet<br>Drug: Carboplatin<br>* intravenous infusion<br>|
| Experimental: 3<br>AZD0530 + Carboplatin + Paclitaxel | Drug: AZD0530<br>* oral tablet<br>Drug: Carboplatin<br>* intravenous infusion<br>Drug: Paclitaxel<br>* intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumors, locally advanced or Metastatic Cancer suitable for treatment with carboplatin and/or paclitaxel