Neoplasms,Phase 1NCT01605916

Investigate the Safety and Tolerability of AZD6244 Monotherapy or + Docetaxel in Japanese Patients With Advanced Solid Malignancies or Non-Small Cell Lung Cancer

A Phase 1 study testing AZD6244 in people with Neoplasms, and Metastatic Cancer,, run by AstraZeneca at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 to 130 years
Conditions the study is for: Neoplasms,, Metastatic Cancer,, Non-Small Cell Lung Cancer
What is being tested?: AZD6244
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 3 sitesJapan
Study dates: Jun 2012to May 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients diagnosed with lung cancer who have not responded to prior therapy or have become worse.
Patients who have overall good general conditions.
Patients who have at least one lesion that can be accurately assessed by imaging.
Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.

Who cannot join

Patients with brain metastases or spinal cord compression.
Patients with significant abnormal ECG findings.
Patients with evidence of severe or uncontrolled systemic disease.
The main organ functional test values for bone marrow, kidney, and liver, etc., do not meet the standards.
Patients with known hypersensitivity to docetaxel or products containing polysorbate 80.
Only for monotherapy cohort eligibility criteria Patients with advanced solid malignancies refractory to standard treatment or for which no standard therapy exists irrespective of the stage and previous treatment.
Patients with histologically or cytologically confirmed advanced solid malignancies.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Research Site
Fukuoka
Research Site
Kashiwa-shi
Research Site
Nagoya

Other trials in Japan

About this study

Official title: A Phase I, Open-Label Study to Investigate the Safety and Tolerability of AZD6244 (Selumetinib) When Given as a Monotherapy in Japanese Patients With Advanced Solid Malignancies, and When Given in Combination With Docetaxel as 2nd Line Therapy in Japanese Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)

The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.

Read the detailed description

The objective of the combination therapy part of this study will be to investigate the safety and tolerability of AZD6244 given in combination with docetaxel as 2nd line therapy in Japanese patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV). In addition, the pharmacokinetic profile of AZD6244 and docetaxel will be investigated.

The objective of the monotherapy part of this study will be to investigate the safety and tolerability of AZD6244 given as a monotherapy in Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile of monotherapy AZD6244 will be investigated.

Conditions: Neoplasms,, Metastatic Cancer,, Non-Small Cell Lung Cancer, Advanced Solid Malignancies
Being tested: AZD6244
Keywords: Cancer,, Tumour,, Metastatic,, Lung cancer,, Non-Small Cell Lung Cancer
Medical subject headings: Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

AZD6244Drug
Also called Selumetinib (AZD6244)
Tablet Oral bid

Study groups in NCT01605916
Study group	Role	What they receive
Selumetinib (AZD6244) 25 mg	Experimental	monotherapy Receives: Drug: AZD6244
Selumetinib (AZD6244) 50 mg	Experimental	monotherapy Receives: Drug: AZD6244
Selumetinib (AZD6244) 75 mg	Experimental	monotherapy Receives: Drug: AZD6244
Selumetinib (AZD6244) 75 mg + Doce	Experimental	Combination Receives: Drug: AZD6244
Selumetinib (AZD6244) 25 mg + Doce	Experimental	combination Receives: Drug: AZD6244

What is being measured

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

Cmax of Selumetinib After Single Dose
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Measured: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Tmax of Selumetinib After Single Dose
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Measured: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
AUC(0-12) of Selumetinib After Single Dose
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib
Measured: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Cmax of N-desmethyl Selumetinib After Single Dose
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Measured: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Tmax of N-desmethyl Selumetinib After Single Dose
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Measured: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
AUC(0-12) of N-desmethyl Selumetinib After Single Dose
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Measured: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib
Measured: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib
Measured: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib
Measured: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
Measured: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
Measured: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
Measured: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Secondary outcomes (3)

Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Measured: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Measured: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib
Measured: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Timeline

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

Jun 2012May 2015

First posted25 May 2012 (estimated)
Study startJun 2012
Primary completionApr 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neoplasms,Studies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01605916
Sponsor's protocol ID: D1532C00067
Status last verified: Sep 2016
First submitted: 21 May 2012
Last updated: 21 Oct 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

All Neoplasms, trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-Label Study to Investigate the Safety and Tolerability of AZD6244 (Selumetinib) When Given as a Monotherapy in Japanese Patients With Advanced Solid Malignancies, and When Given in Combination With Docetaxel as 2nd Line Therapy in Japanese Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)
ClinicalTrials.gov ID: NCT01605916
Acronym / sponsor ID: D1532C00067
Conditions: Neoplasms,, Metastatic Cancer,, Non-Small Cell Lung Cancer, Advanced Solid Malignancies
Keywords: Cancer,, Tumour,, Metastatic,, Lung cancer,, Non-Small Cell Lung Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Apr 2015 (actual)
Study completion: May 2015 (actual)
First posted: 25 May 2012 (estimated)
Results: Posted 14 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Selumetinib (AZD6244) 25 mg	Experimental	Drug: AZD6244monotherapy
Selumetinib (AZD6244) 50 mg	Experimental	Drug: AZD6244monotherapy
Selumetinib (AZD6244) 75 mg	Experimental	Drug: AZD6244monotherapy
Selumetinib (AZD6244) 75 mg + Doce	Experimental	Drug: AZD6244Combination
Selumetinib (AZD6244) 25 mg + Doce	Experimental	Drug: AZD6244combination

Who may qualify

Ages: 20 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients diagnosed with lung cancer who have not responded to prior therapy or have become worse.
Patients who have overall good general conditions.
Patients who have at least one lesion that can be accurately assessed by imaging.
Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.

Key exclusion criteria (7 listed)

Patients with brain metastases or spinal cord compression.
Patients with significant abnormal ECG findings.
Patients with evidence of severe or uncontrolled systemic disease.
The main organ functional test values for bone marrow, kidney, and liver, etc., do not meet the standards.
Patients with known hypersensitivity to docetaxel or products containing polysorbate 80.

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: Selumetinib (AZD6244)Tablet Oral bid	Drug	Selumetinib (AZD6244) 25 mg, Selumetinib (AZD6244) 25 mg + Doce, Selumetinib (AZD6244) 50 mg, Selumetinib (AZD6244) 75 mg, Selumetinib (AZD6244) 75 mg + Doce

Primary outcome

Cmax of Selumetinib After Single Dose
Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
Tmax of Selumetinib After Single Dose
Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib
AUC(0-12) of Selumetinib After Single Dose
Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib
Cmax of N-desmethyl Selumetinib After Single Dose
Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Tmax of N-desmethyl Selumetinib After Single Dose
Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib
AUC(0-12) of N-desmethyl Selumetinib After Single Dose
Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib
Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib
Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib
Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib
Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib
AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib
Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib
Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib
AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib
Time frame: Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib

3 secondary outcomes

Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose
AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2
Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose

Results and safety

Results posted to the registry on 14 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce	4	0
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce	4	0
Monotherapy Cohort 1 Selumetinib 25 mg	4	1
Monotherapy Cohort 2 Selumetinib 50 mg	6	0
Monotherapy Cohort 3 Selumetinib 75 mg	7	1

Primary outcome: Cmax of Selumetinib After Single Dose

Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Combination Therapy Cohort 1 Selumetinib 75 mg + Doce n = 4	Combination Therapy Cohort 2 Selumetinib 25 mg + Doce n = 4	Monotherapy Cohort 1 Selumetinib 25 mg n = 4	Monotherapy Cohort 2 Selumetinib 50 mg n = 6	Monotherapy Cohort 3 Selumetinib 75 mg n = 7
Value	2534 (40.45)	1073 (35.18)	370.3 (96.87)	897.1 (69.34)	2084 (50.85)

Population analysed: Pharmacokinetic Analysis Set

Primary outcome: Tmax of Selumetinib After Single Dose

Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose. Median (Full Range). Unit: hour

Measure	Combination Therapy Cohort 1 Selumetinib 75 mg + Doce n = 4	Combination Therapy Cohort 2 Selumetinib 25 mg + Doce n = 4	Monotherapy Cohort 1 Selumetinib 25 mg n = 4	Monotherapy Cohort 2 Selumetinib 50 mg n = 6	Monotherapy Cohort 3 Selumetinib 75 mg n = 7
Value	1.49 (40.45)	1.00 (35.18)	1.74 (0.47 to 4.05)	1.51 (0.93 to 4.12)	0.98 (0.93 to 2.00)

Population analysed: Pharmacokinetic Analysis Set

Primary outcome: AUC(0-12) of Selumetinib After Single Dose

Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*h/mL

Measure	Combination Therapy Cohort 1 Selumetinib 75 mg + Doce n = 4	Combination Therapy Cohort 2 Selumetinib 25 mg + Doce n = 4	Monotherapy Cohort 1 Selumetinib 25 mg n = 4	Monotherapy Cohort 2 Selumetinib 50 mg n = 6	Monotherapy Cohort 3 Selumetinib 75 mg n = 7
Value	6784 (26.63)	1599 (35.48)	1021 (30.62)	2723 (33.24)	5578 (35.77)

Population analysed: Pharmacokinetic Analysis Set

Primary outcome: Cmax of N-desmethyl Selumetinib After Single Dose

Time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Combination Therapy Cohort 1 Selumetinib 75 mg + Doce n = 4	Combination Therapy Cohort 2 Selumetinib 25 mg + Doce n = 4	Monotherapy Cohort 1 Selumetinib 25 mg n = 4	Monotherapy Cohort 2 Selumetinib 50 mg n = 6	Monotherapy Cohort 3 Selumetinib 75 mg n = 7
Value	130.8 (63.44)	68.61 (15.10)	27.50 (41.42)	46.55 (57.74)	136.6 (29.28)

Population analysed: Pharmacokinetic Analysis Set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the study, from informed consent until the end of the followup period. The follow-up period is defined as 28 days after investigational prooduct and/or docetaxel is discontinued.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combination Therapy Cohort 1 Selumetinib 75 mg + Doce	0 of 4 (0%)	4 of 4 (100%)	Not reported
Combination Therapy Cohort 2 Selumetinib 25 mg + Doce	0 of 4 (0%)	4 of 4 (100%)	Not reported
Monotherapy Cohort 1 Selumetinib 25 mg	1 of 4 (25%)	4 of 4 (100%)	Not reported
Monotherapy Cohort 2 Selumetinib 50 mg	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
Monotherapy Cohort 3 Selumetinib 75 mg	2 of 7 (28.6%)	7 of 7 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Neoplasms,

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer

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.

Ian Smith, Medical Science Director study director

AstraZeneca

Yuichiro Ohe, Medical Doctor principal investigator

National Cancer Centre East

Hideo Saka, Medical Doctor principal investigator

National Hospital Organisation Nagoya Medical Centre

3 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 in people with Neoplasms, and Metastatic Cancer,, run by AstraZeneca at 3 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 5 inclusion and 7 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. 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?

Yes. Results are posted in the registry (first posted 14 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax of Selumetinib After Single Dose (time frame: Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose). The study lists 12 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 NCT01605916.

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 21 Oct 2016.