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Carcinoma, Non-Small-Cell LungPhase 1NCT00539331

Phase I/II Study of AZD2171 in Combination With Paclitaxel/Carboplatin in Japanese Non-Small Cell Lung Cancer Patients

A Phase 1 study testing AZD2171, Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 2 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
AZD2171, Paclitaxel and Carboplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
2 sitesJapan
Study dates
Sep 2007to Sep 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Having histologically or cytologically confirmed NSCLC
  • Patients with previously untreated advanced/metastatic (Stage IIIB/IV) or postsurgery recurrent NSCLC
  • WHO performance status 0-1

Who cannot join

  • Untreated unstable brain or meningeal metastases
  • Patient with inappropriate laboratory tests values
  • Patient with poorly controlled hypertension

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Research Site

    Osaka

  • Research Site

    Tokyo

Other trials in Japan

About this study

Official title: A Two-Part Study in Japanese Patients With Advanced or Metastatic NSCLC. Open-Label Phase I to Assess the Safety & Tolerability of AZD2171 in Combination With Pac/Carb, Then a Phase II, Randomised, Double-Blind Study to Assess the Efficacy of Pac/Carb Alone and in Combination With AZD2171 and Pac/Carb

The National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of cediranib at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study's Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III. As the design of Study 040 is similar to that of Study BR24, AstraZeneca has suspended recruitment into Study 040.

Being tested
AZD2171, Paclitaxel, Carboplatin
Keywords
Non-small Cell Lung Cancer, NSCLC, AZD2171, Paclitaxel/Carboplatin, Non-small Cell Lung Cancer (NSCLC)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD2171Drug

    Also called cediranib, RECENTIN™

    oral tablet

  • PaclitaxelDrug

    Also called Taxol®

    intravenous infusion

  • CarboplatinDrug

    Also called CBDCA, Paraplatin®

    intravenous injection

Study groups in NCT00539331
Study groupRoleWhat they receive
1Placebo comparatorPaclitaxel/Carboplatin
Receives: Drug: Paclitaxel; Drug: Carboplatin
2ExperimentalPaclitaxel/Carboplatin + AZD2171
Receives: Drug: AZD2171; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer

    Measured: Assessed at each visit during Part A

  2. PART B : Assess the efficacy of AZD2171 by assessment of progression free survival (PFS)

    Measured: time to progression

Secondary outcomes (2)

  1. PART A : To examine the effect of AZD2171 on the PK of carboplatin and paclitaxel

    Measured: Assessed at each visit during Part A

  2. PART B : To determine the efficacy of AZD2171 by assessment of overall response rate, change in tumour size and overall survival

    Measured: time to death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00539331
Sponsor's protocol ID
D8480C00040
Status last verified
May 2011
First submitted
2 Oct 2007
Last updated
1 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD2171, Paclitaxel and Carboplatin in people with Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PART A : Safety and tolerability of AZD2171 in combination with pac/carbo in patients with non-small cell lung cancer (time frame: Assessed at each visit during Part A). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00539331.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.

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