Phase I Study in Patients With Solid Tumours

NCT00496028 | Completed Phase 1 DMC

• 2 other identifiers: D8180C00023AZD0530 study 23
• Study Type: interventional
• Target: 148
• Locations: 4 countries
• Sites: 7

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.

Conditions

Neoplasms

Keywords

Solid tumors; locally advanced or Metastatic Cancer suitable for treatment with carboplatin and/or paclitaxel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

1

EXPERIMENTAL

AZD0530 + Paclitaxel

Drug: AZD0530; Drug: Paclitaxel

2

EXPERIMENTAL

AZD0530 + Carboplatin

Drug: AZD0530; Drug: Carboplatin

3

EXPERIMENTAL

AZD0530 + Carboplatin + Paclitaxel

Drug: AZD0530; Drug: Carboplatin; Drug: Paclitaxel

Interventions

AZD0530 DRUG

oral tablet

1; 2; 3

Carboplatin DRUG

intravenous infusion

2; 3

Paclitaxel DRUG

intravenous infusion

1; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inadequate bone marrow reserve
• Inadequate live function, renal function or low haemoglobin
• Unresolved toxicity from anti-cancer therapy

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Paris, France

Location

Research Site

Pierre-Bénite, France

Location

Research Site

Amsterdam, Netherlands

Location

Research Site

Groningen, Netherlands

Location

Research Site

Oslo, Norway

Location

Research Site

Glasgow, United Kingdom

Location

Research Site

Sutton, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

saracatinib; Carboplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Steinar Aamdal, MD

  Radium Hospital, Norway

  PRINCIPAL INVESTIGATOR

• Mary Stuart, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 22, 2010

Record last verified: 2010-09

Locations

FR (2); NL (2); GB (2); NO (1)