Comparison of AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive Non Small Cell Lung Cancer (NSCLC) Patients
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00890825
First received: April 29, 2009
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: AZD6244 Drug: docetaxel Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic Non Small Cell Lung Cancer (Stage IIIB- IV) |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- To assess the efficacy in terms of Overall Survival (OS) of AZD6244 in combination with docetaxel compared with docetaxel alone, in 2nd line patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer [ Time Frame: Time Frame: Overall survival calculated as the interval from date of randomisation to date of patient death (any cause). Patients who have not died at final analysis, or who withdraw consent, will be censored at last date they were known to be alive. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To further assess the efficacy in terms of:- Progression Free Survival (PFS) -Objective Response Rate (ORR)- Duration of Response (DoR)- Change in tumour size at 12 weeks- Alive and Progression Free at 6 months (APF6) [ Time Frame: PFS, ORR, DoR, APF6 and change in tumour size at 12 weeks will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 12 weeks thereafter relative to randomisation. ] [ Designated as safety issue: No ]
- To assess the safety and tolerability profile of AZD6244 in combination with docetaxel [ Time Frame: At every visit (ie weekly for the first 6 weeks and then every 3 weeks) ] [ Designated as safety issue: Yes ]
- To investigate the pharmacokinetics of AZD6244 [ Time Frame: At Day 1 and Day 22 ] [ Designated as safety issue: No ]
| Enrollment: | 87 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
AZD6244 in combination with docetaxel
|
Drug: AZD6244
oral capsules, 75mg twice daily
Drug: docetaxel
75mg/m2 iv on day 1 of every 21 day cycle
Other Name: Taxotere
|
|
Placebo Comparator: 2
Placebo in combination with docetaxel
|
Drug: docetaxel
75mg/m2 iv on day 1 of every 21 day cycle
Other Name: Taxotere
Drug: Placebo
placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Locally advanced or metastatic non small cell lung cancer (IIIB-IV)
- Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
- Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg Genzyme or Lab 21).
Exclusion Criteria:
- Received >1 prior anti-cancer therapy for advanced or metastatic non small cell lung cancer (excluding radiotherapy)
- Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable)
- Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug
- Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890825
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| United States, California | |
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| Los Angeles, California, United States | |
| United States, Colorado | |
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| Aurora, Colorado, United States | |
| United States, Massachusetts | |
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| Columbus, Ohio, United States | |
| Belgium | |
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| Brussels (jette), Belgium | |
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| Charleroi, Belgium | |
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| Edegem, Belgium | |
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| Leuven, Belgium | |
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| Liege, Belgium | |
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| Belo Horizonte, MG, Brazil | |
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| Rio de Janeiro, RJ, Brazil | |
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| Ijui, RS, Brazil | |
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| Porto Alegre, RS, Brazil | |
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| Santo Andre, SP, Brazil | |
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| Sao Paulo, Brazil | |
| Bulgaria | |
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| Plovdiv, Bulgaria | |
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| Sofia, Bulgaria | |
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| Varna, Bulgaria | |
| Canada, Ontario | |
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| Oshawa, Ontario, Canada | |
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| Ottawa, Ontario, Canada | |
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| Toronto, Ontario, Canada | |
| Czech Republic | |
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| Praha 8, CZ, Czech Republic | |
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| Ostrava, Czech Republic | |
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| Znojmo, Czech Republic | |
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| Brest Cedex, France | |
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| Clermont Ferrand, France | |
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| Dijon, France | |
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| Lyon Cedex 08, France | |
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| Marseille Cedex 20, France | |
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| Rennes Cedex 9, France | |
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| Budapest, Hungary | |
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| Gyor, Hungary | |
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| Mosdos, Hungary | |
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| Szekesfehervar, Hungary | |
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| Torokbalint, Hungary | |
| Italy | |
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| Bologna, BO, Italy | |
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| Genova, GE, Italy | |
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| MILANO (Milano-Osp. Niguarda), MI, Italy | |
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| Rozzano, MI, Italy | |
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| Perugia, PG, Italy | |
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| Orbassano, TO, Italy | |
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| Roma, Italy | |
| Mexico | |
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| Mexico, D.f., Mexico | |
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| Morelia, Michoacan, Mexico | |
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| Zacatecas, Mexico | |
| Peru | |
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| Lima, Peru | |
| Spain | |
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| Malaga, Andalucia, Spain | |
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| Barcelona, Cataluna, Spain | |
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| Madrid, Comunidad de Madrid, Spain | |
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| A Coruna, Galicia, Spain | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Dr Pasi Janne | Dana-Farber Cancer Institute, Boston, USA |
| Study Director: | Dr Ian Smith | AstraZeneca, Alderley Park, UK |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00890825 History of Changes |
| Other Study ID Numbers: | D1532C00016 |
| Study First Received: | April 29, 2009 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Non small cell lung cancer (NSCLC) KRAS mutation |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013