Phase I Study in Patients With Solid Tumours
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00496028
First received: July 3, 2007
Last updated: September 21, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: AZD0530 Drug: Carboplatin Drug: Paclitaxel |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: Assessed at each visit ] [ Designated as safety issue: Yes ]
- To make a preliminary evaluation of clinical response by assessment of RECIST evaluation, time to progression and serum tumour markers. [ Time Frame: Assessment at end of study ] [ Designated as safety issue: No ]
- To investigate the PK of AZD0530. paclitaxel and carboplatin when co-administered to patients with solid tumours, by assessment of appropriate PK parameters. [ Time Frame: Predetermined timepoints after dose administration ] [ Designated as safety issue: No ]
| Enrollment: | 148 |
| Study Start Date: | March 2007 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
AZD0530 + Paclitaxel
|
Drug: AZD0530
oral tablet
Drug: Paclitaxel
intravenous infusion
|
|
Experimental: 2
AZD0530 + Carboplatin
|
Drug: AZD0530
oral tablet
Drug: Carboplatin
intravenous infusion
|
|
Experimental: 3
AZD0530 + Carboplatin + Paclitaxel
|
Drug: AZD0530
oral tablet
Drug: Carboplatin
intravenous infusion
Drug: Paclitaxel
intravenous infusion
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496028
Locations
| France | |
| Research Site | |
| Paris, France | |
| Research Site | |
| Pierre Benite Cedex, France | |
| Netherlands | |
| Research Site | |
| Amsterdam, Netherlands | |
| Research Site | |
| Groningen, Netherlands | |
| Norway | |
| Research Site | |
| Oslo, Norway | |
| United Kingdom | |
| Research Site | |
| Glasgow, United Kingdom | |
| Research Site | |
| Sutton, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Steinar Aamdal, MD | Radium Hospital, Norway |
| Study Director: | Mary Stuart, MD | AstraZeneca |
More Information
No publications provided
| Responsible Party: | Mary Stuart, MD - Medical Science Director EPT1, AstraZeneca Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00496028 History of Changes |
| Other Study ID Numbers: | D8180C00023, AZD0530 study 23 |
| Study First Received: | July 3, 2007 |
| Last Updated: | September 21, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Norway: Norwegian Medicines Agency Netherlands: Dutch Health Care Inspectorate France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by AstraZeneca:
|
Solid tumors locally advanced or Metastatic Cancer suitable for treatment with carboplatin and/or paclitaxel |
Additional relevant MeSH terms:
|
Neoplasms Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013