Breast CancerPhase 1NCT00600496
A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)
A Phase 1 study testing AZD6244, Dacarbazine and Erlotinib in people with Breast Cancer and Breast Neoplasms, run by AstraZeneca at 4 sites in United States.
Trial summary
This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Colon Cancer
- What is being tested?
- AZD6244, Dacarbazine and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Dec 2007to 18 Dec 2025
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will have measurable and/or non-measurable disease, lacking curative options for whom the selected chemotherapy agents represent the standard of care
- WHO performance status 0-1
- Patients must be able to swallow AZD6244 capsules
Who cannot join
- Prior treatment with a MEK inhibitor
- Participation in a clinical study during the last 30 days or have not recovered from side effects of an investigational study drug
- Brain metastases or spinal cord compression unless treated and stable (for at least 1 month) off steroids
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Site
Detroit, Michigan, 48201
Research Site
Houston, Texas, 77030
Research Site
Nashville, Tennessee, 37203
Research Site
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors
This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies
- Conditions
- Breast Cancer, Breast Neoplasms, Colon Cancer, Colonic Cancer, Colon Neoplasms, Lung Cancer
- Keywords
- ARRY-142886, AZD6244, Cancer, Colon Cancer, Breast Cancer, Lung Cancer, Melanoma, Kidney Cancer
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Melanoma, Kidney Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6244Drug
Also called ARRY-142886
twice daily oral dose
DacarbazineDrug
intravenous infusion
ErlotinibDrug
daily oral dose
DocetaxelDrug
Also called Taxotere®
intravenous infusion
TemsirolimusDrug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD6244 + docetaxel Receives: Drug: AZD6244; Drug: Docetaxel |
| 2 | Experimental | AZD6244 + Dacarbazine Receives: Drug: AZD6244; Drug: Dacarbazine |
| 3 | Experimental | AZD6244 + Erlotinib Receives: Drug: AZD6244; Drug: Erlotinib |
| 4 | Experimental | AZD6244 + Temsirolimus Receives: Drug: AZD6244; Drug: Temsirolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies.
Incidence and intensity of adverse events as graded by CTCAE (version 3.0), physical examinations, vital signs (including weight, blood pressure and pulse rate), ECG parameters, MUGA scan and echocardiography, clinical chemistry (including liver function tests), Brain Natriuretic Peptide (BNP), Troponin I, hematology, urinalysis, and ophthalmologic examinations.
Measured: 28 days +
Secondary outcomes (3)
PK of AZD6244 and selected chemotherapies.
The PK parameters will be derived using noncompartmental analysis. The maximum plasma concentrations (Cmax) and the time to reach the maximum plasma concentrations (tmax) will be determined by visual inspection of the plasma concentration-time profiles. The area under the plasma concentration-time curve from zero to 12 hours post dose, AUC(0-12), will be calculated by the linear trapezoidal rule. Where more than one maxima occurs, the reported value will be assigned to the first occurrence.
Measured: Cycle 1 Day 3 and Cycle 2 day 1
Define highest tolerated dose of AZD6244 when in combination with selected chemotherapies.
The starting dose of AZD6244 in each arm will be 50mg. Continuous dosing (commencing Cycle 1/Day 3 for docetaxel and dacarbazine and Cycle 1/Day 8 for erlotinib and temsirolimus) will be BD. The AZD6244 dose may be maintained or reduced.
Measured: 28 days +
Tumor response.
To make a preliminary assessment of tumor response as measured by Objective Response Rate (ORR) per investigator's assessment using Response Evaluation Criteria in Solid Tumors (RECIST) when AZD6244 Hyd-Sulfate is given in combination with standard doses of selected chemotherapies.
Measured: 28 days +
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study start14 Dec 2007
- Primary completion20 Aug 2010
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia LoRusso, DO, Principal investigator, Barbara Ann Karmanos Cancer InstituteRoger Cohen, MD, Principal investigator, Fox Chase Cancer CenterJeffrey Infante, MD, Principal investigator, SCRI Development Innovations, LLCKevin Kim, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600496
- Sponsor's protocol ID
- D1532C00004
- Status last verified
- Mar 2026
- First submitted
- 15 Jan 2008
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Publications
Infante JR, Cohen RB, Kim KB, Burris HA 3rd, Curt G, Emeribe U, Clemett D, Tomkinson HK, LoRusso PM. A phase I dose-escalation study of Selumetinib in combination with Erlotinib or Temsirolimus in patients with advanced solid tumors. Invest New Drugs. 2017 Oct;35(5):576-588. doi: 10.1007/s10637-017-0459-7. Epub 2017 Apr 19.
PubMed 28424891LoRusso PM, Infante JR, Kim KB, Burris HA 3rd, Curt G, Emeribe U, Clemett D, Tomkinson HK, Cohen RB. A phase I dose-escalation study of selumetinib in combination with docetaxel or dacarbazine in patients with advanced solid tumors. BMC Cancer. 2017 Mar 6;17(1):173. doi: 10.1186/s12885-017-3143-6.
PubMed 28264648Patel SP, Lazar AJ, Papadopoulos NE, Liu P, Infante JR, Glass MR, Vaughn CS, LoRusso PM, Cohen RB, Davies MA, Kim KB. Clinical responses to selumetinib (AZD6244; ARRY-142886)-based combination therapy stratified by gene mutations in patients with metastatic melanoma. Cancer. 2013 Feb 15;119(4):799-805. doi: 10.1002/cncr.27790. Epub 2012 Sep 12.
PubMed 22972589
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00600496
- Acronym / sponsor ID
- D1532C00004
- Conditions
- Breast Cancer, Breast Neoplasms, Colon Cancer, Colonic Cancer, Colon Neoplasms, Lung Cancer
- Keywords
- ARRY-142886, AZD6244, Cancer, Colon Cancer, Breast Cancer, Lung Cancer, Melanoma, Kidney Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2007 (actual)
- Primary completion
- 20 Aug 2010 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD6244, Drug: DocetaxelAZD6244 + docetaxel |
| 2 | Experimental | Drug: AZD6244, Drug: DacarbazineAZD6244 + Dacarbazine |
| 3 | Experimental | Drug: AZD6244, Drug: ErlotinibAZD6244 + Erlotinib |
| 4 | Experimental | Drug: AZD6244, Drug: TemsirolimusAZD6244 + Temsirolimus |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients will have measurable and/or non-measurable disease, lacking curative options for whom the selected chemotherapy agents represent the standard of care
- WHO performance status 0-1
- Patients must be able to swallow AZD6244 capsules
Key exclusion criteria (3 listed)
- Prior treatment with a MEK inhibitor
- Participation in a clinical study during the last 30 days or have not recovered from side effects of an investigational study drug
- Brain metastases or spinal cord compression unless treated and stable (for at least 1 month) off steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD6244Also: ARRY-142886twice daily oral dose | Drug | 1, 2, 3, 4 |
| Dacarbazineintravenous infusion | Drug | 2 |
| Erlotinibdaily oral dose | Drug | 3 |
| DocetaxelAlso: Taxotere®intravenous infusion | Drug | 1 |
| Temsirolimusintravenous infusion | Drug | 4 |
Primary outcome
Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies.
Time frame: 28 days +
Incidence and intensity of adverse events as graded by CTCAE (version 3.0), physical examinations, vital signs (including weight, blood pressure and pulse rate), ECG parameters, MUGA scan and echocardiography, clinical chemistry (including liver function tests), Brain Natriuretic Peptide (BNP), Troponin I, hematology, urinalysis, and ophthalmologic examinations.
3 secondary outcomes
PK of AZD6244 and selected chemotherapies.
Time frame: Cycle 1 Day 3 and Cycle 2 day 1
Define highest tolerated dose of AZD6244 when in combination with selected chemotherapies.
Time frame: 28 days +
Tumor response.
Time frame: 28 days +
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Derived from this study: PubMed 28424891Infante JR, Cohen RB, Kim KB, Burris HA 3rd, Curt G, Emeribe U, Clemett D, Tomkinson HK, LoRusso PM. A phase I dose-escalation study of Selumetinib in combination with Erlotinib or Temsirolimus in patients with advanced solid tumors. Invest New Drugs. 2017 Oct;35(5):576-588. doi: 10.1007/s10637-017-0459-7. Epub 2017 Apr 19.
- Derived from this study: PubMed 28264648LoRusso PM, Infante JR, Kim KB, Burris HA 3rd, Curt G, Emeribe U, Clemett D, Tomkinson HK, Cohen RB. A phase I dose-escalation study of selumetinib in combination with docetaxel or dacarbazine in patients with advanced solid tumors. BMC Cancer. 2017 Mar 6;17(1):173. doi: 10.1186/s12885-017-3143-6.
- Derived from this study: PubMed 22972589Patel SP, Lazar AJ, Papadopoulos NE, Liu P, Infante JR, Glass MR, Vaughn CS, LoRusso PM, Cohen RB, Davies MA, Kim KB. Clinical responses to selumetinib (AZD6244; ARRY-142886)-based combination therapy stratified by gene mutations in patients with metastatic melanoma. Cancer. 2013 Feb 15;119(4):799-805. doi: 10.1002/cncr.27790. Epub 2012 Sep 12.
- D1532C00004 Clinical Report SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia LoRusso, DO principal investigator
Barbara Ann Karmanos Cancer Institute
Roger Cohen, MD principal investigator
Fox Chase Cancer Center
Jeffrey Infante, MD principal investigator
SCRI Development Innovations, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6244, Dacarbazine and Erlotinib in people with Breast Cancer and Breast Neoplasms, run by AstraZeneca at 4 sites in United States.
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: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies. (time frame: 28 days +). 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 NCT00600496, which also lists 3 linked publications.
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 27 May 2026.