Advanced Adenocarcinoma of the Colon or RectumPhase 1NCT01605344

Crossover Evaluation of Effect of Atorvastatin on PK of Irinotecan in CRC Patients Receiving FOLFIRI

A Phase 1 study testing FOLFIRI. and Atorvastatin in people with Advanced Adenocarcinoma of the Colon or Rectum, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetic profile of irinotecan and SN-38. To further evaluate the safety of atorvastatin in combination with FOLFIRI. To further evaluate the safety and of irinotecan in combination with atorvastatin. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Adenocarcinoma of the Colon or Rectum
What is being tested?: FOLFIRI. and Atorvastatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Jul 2014
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

Age ≥18 years of age (no upper age limit)
Histological or cytological documentation of adenocarcinoma of the colon or rectum, and patient scheduled to begin FOLFIRI for treatment of their metastatic disease
Patients taking statins at the time of enrollment are permitted. Patients taking statins (or one of the prohibited drugs, see section 4.2.27 and section 12.1) must agree to a 2 week washout prior to treatment with atorvastatin (see Schema) and section 5.2
Life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of treatment initiation with atorvastatin (or nothing, if enrolled into Arm B): absolute neutrophil count (ANC) ≥1,500/mm3 platelets ≥100,000/mm3 hemoglobin ≥9.0 g/dL serum creatinine ≤1.5 x upper limit of normal (ULN) AST and ALT ≤ 3 x ULN Total bilirubin ≤ 1.5 x ULN Alkaline phosphatase ≤2.5 x ULN Amylase and lipase ≤1.5 x ULN INR/PTT ≤1.5 x ULN CPK ≤ ULN

Show all 10Show fewer

Women of childbearing potential and male subjects must agree to use adequate contraception for the duration of study participation. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care.
Medical oncologist agrees that two week window is appropriate/safe prior to start of FOLFIRI for trial candidate.
The subject is capable of understanding and complying with parameters as outlined in the protocol
Signed, IRB-approved written informed consent

Who cannot join

Any prior allergies to statin therapy or adverse events that precluded further use, including but not limited to myopathy, rhabdomyolysis, etc. Patients who had to change from atorvastatin to another statin for safety or efficacy reasons will also be excluded.
Prior treatment with FOLFIRI or single agent irinotecan is prohibited within six weeks of enrollment. All prior toxicity from previous irinotecan administration must be resolved prior to enrollment. No more than 2 prior therapeutic regimens for metastatic disease are allowed.
Patients will not be allowed to receive bevacizumab or EGFR inhibitors (cetuximab or panitumumab) for the duration of the study (1 cycle).
Patients with baseline LDL ≤ 100 mg/dL who are not currently treated with statins
Patients homozygous for the UGT1A1*28 allele, and patients of Asian descent homozygous or heterozygous for the UGT1A1*6 allele will be excluded due to their altered irinotecan metabolism
Pregnant or breastfeeding patients. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of atorvastatin and FOLFIRI treatment, and a negative result must be documented before start of treatment with atorvastatin or FOLFIRI (whichever is received first by patient).

Show all 29Show fewer

Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) ≤2 weeks prior to starting study drug. Erythropoietin or darbepoetin therapy, if initiated ≥2 weeks prior to enrollment, may be continued.
History of Gilbert's syndrome
Pernicious anemia or other anemias due to Vitamin B12 deficiency (due to potential masking of deficiency by leucovorin)
Known Dihydropyrimidine dehydrogenase (DPD) deficiency
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of Day 1 of treatment with FOLFIRI
Any patients with a history of stroke or TIA within 6 months prior to study enrollment
Active cardiac disease including any of the following: Congestive heart failure (New York Heart Association [NYHA]) ≥Class 2 (see Appendix C) Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of Day 1 of FOLFIRI Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
Ongoing infection > Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0)
Known history of human immunodeficiency virus (HIV) infection
Presence of acute or chronic liver disease, renal disease or pancreatitis
Known history of chronic hepatitis B or C
Symptomatic metastatic brain or meningeal tumors unless the patient is >6 months from definitive therapy, has a negative imaging study within 4 weeks of FOLFIRI initiation, and is clinically stable with respect to the tumor at the time of study entry. Also, the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is s4.2.2table for one month prior to D1 of treatment under this study)
History of organ allograft
Non-healing wound, ulcer, or bone fracture
Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
Inability to swallow oral medications
Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event > Grade 4 within 4 weeks of start of FOLFIRI
Patients with diarrhea CTCAE v4 grade ≥2
Any malabsorption condition
Unresolved toxicity higher than CTCAE v. 4.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin-induced neurotoxicity (which must be ≤Grade 2)
Patients unable or unwilling to discontinue (and substitute if necessary) use of prohibited drugs, juices and herbal supplements for at least 2 weeks prior to atorvastatin initiation (see Appendix A for list of prohibited drugs, juices and herbal supplements)
Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Unwilling to provide consent for genetic studies of whole blood or plasma specimens

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: A Prospective, Randomized, Crossover Evaluation of the Effect of Atorvastatin on the Pharmacokinetics of Irinotecan in Colorectal Cancer Patients Receiving FOLFIRI

Read the detailed description

This is a single-center, prospective, randomized, crossover study to address the pharmacokinetic effects of atorvastatin on irinotecan metabolism in patients receiving their first cycle of FOLFIRI (5-fluorouracil + leucovorin + irinotecan).

Each cycle of FOLFIRI is defined as 28 days, with a dose of FOLFIRI administered on day 1 and day 15. Patients will be recruited from the UNC Lineberger Cancer Center, referred by their primary oncologist for the treatment of metastatic colorectal cancer (mCRC). After obtaining informed consent, the patient will be randomized to either ARM A or ARM B.

Blood samples will be collected on day 1 and 15 of FOLFIRI prior to treatment with irinotecan (baseline), immediately following the end of the irinotecan infusion, and at 0.5, 1, 1.5, 2, 4, 6, and 24 hours following the end of the irinotecan infusion.

ARM A subjects will receive atorvastatin 20 mg orally once daily given for two weeks starting on Day -14 during PERIOD ONE. ARM A will then receive no statin during PERIOD TWO. Patients will receive FOLFIRI infusion on day 1 and day 15. Blood samples will be collected at baseline and periodically through 24 hours.

ARM B subjects will receive no atorvastatin during PERIOD ONE. ARM B subjects will receive atorvastatin 20 mg orally once daily for two weeks during PERIOD TWO (starting on Day 2). Patients will receive FOLFIRI infusion on day 1 and day 15. Blood samples will be collected at baseline and periodically through 24 hours.

DNA extraction and genetic analysis of UGT1A1 polymorphisms will be performed in collaboration with Dr. Federico Innocenti and those patients homozygous for the UGT1A1*28 allele will be excluded due to their altered irinotecan metabolism.

Patients will be followed until Day 1 of Cycle 2 of FOLFIRI. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the event(s).

Conditions: Advanced Adenocarcinoma of the Colon or Rectum
Being tested: FOLFIRI., Atorvastatin
Keywords: Advanced colon cancer, Advanced rectal cancer, Metastatic colon cancer, Metastatic rectal cancer, Lipitor, Atorvastatin, FOLFIRI
Medical subject headings: Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

FOLFIRI.Drug
Also called 5-fluorouracil + leucovorin + irinotecan
All patients will receive FOLFIRI infusion on day 1 and day 15.
AtorvastatinDrug
Also called Lipitor
A subjects will receive atorvastatin 20 mg orally once daily given for two weeks starting on Day -14 during PERIOD ONE. ARM A will then receive no statin during PERIOD TWO. ARM B subjects will receive no atorvastatin during PERIOD ONE. ARM B subjects will receive atorvastatin 20 mg orally once daily for two weeks during PERIOD TWO (starting on Day 2). One cycle = 28 days.

Study groups in NCT01605344
Study group	Role	What they receive
Arm A	Experimental	ARM A subjects will receive atorvastatin 20 mg orally once daily given for two weeks prior to FOLFIRI. The last dose of atorvastatin will be taken day 1 of FOLFIRI. ARM A will then receive no statin for the next 2 weeks. Patients will receive FOLFIRI infusion on day 1 and day 15. Blood samples will be collected at baseline and periodically through 24 hours on day 1 and 15 of FOLFIRI. Receives: Drug: FOLFIRI.; Drug: Atorvastatin
Arm B	Experimental	ARM B subjects will receive no atorvastatin prior to day 1 of FOLFIRI. ARM B subjects will receive atorvastatin 20 mg orally once daily for two weeks prior to day 15 of FOLFIRI. The last dose of atorvastatin will be taken day 15 of FOLFIRI. Patients will receive FOLFIRI infusion on day 1 and day 15. Blood samples will be collected at baseline and periodically through 24 hours on day 1 and 15 of FOLFIRI. Receives: Drug: FOLFIRI.; Drug: Atorvastatin

What is being measured

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

Area under the plasma concentration versus time curve (AUC) of irinotecan.
At the end of the screening period, eligible patients will be randomly assigned in a 1:1 ratio to receive atorvastatin prior to Day 1 of FOLFIRI (ARM A) or atorvastatin prior to Day 15 FOLFIRI (ARM B). Patients in ARM A must start atorvastatin within 28 days of randomization and patients in ARM B should receive FOLFIRI within 28 days of randomization; if not, the Investigator must be notified.
Measured: Blood samples will be collected on day 1 and 15 of FOLFIRI prior to treatment with irinotecan (baseline), immediately following the end of the irinotecan infusion, and at 0.5, 1, 1.5, 2, 4, 6, and 24 hours following the end of the irinotecan infusion.

Secondary outcomes (1)

Area under the plasma concentration versus time curve (AUC) of SN-38.
At the end of the screening period, eligible patients will be randomly assigned in a 1:1 ratio to receive atorvastatin prior to Day 1 of FOLFIRI (ARM A) or atorvastatin prior to Day 15 FOLFIRI (ARM B). Patients in ARM A must start atorvastatin within 28 days of randomization and patients in ARM B should receive FOLFIRI within 28 days of randomization; if not, the Investigator must be notified.
Measured: Blood samples will be collected on day 1 and 15 of FOLFIRI prior to treatment with irinotecan (baseline), immediately following the end of the irinotecan infusion, and at 0.5, 1, 1.5, 2, 4, 6, and 24 hours following the end of the irinotecan infusion.

Timeline

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

Apr 2012Jul 2014

First posted24 May 2012 (estimated)
Study startApr 2012
Primary completionJul 2013 (estimated)
Study completionJul 2014 (estimated)

Why it stopped: Study was withdrawn due to lack of patient enrollment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Adenocarcinoma of the Colon or RectumStudies of the same condition, open and under way.
More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01605344
Sponsor's protocol ID: LCCC 1127
Status last verified: Feb 2014
First submitted: 22 May 2012
Last updated: 27 Feb 2014
Results posted: No
Data monitoring committee: Yes

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

RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

All Advanced Adenocarcinoma of the Colon or Rectum trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Crossover Evaluation of the Effect of Atorvastatin on the Pharmacokinetics of Irinotecan in Colorectal Cancer Patients Receiving FOLFIRI
ClinicalTrials.gov ID: NCT01605344
Acronym / sponsor ID: LCCC 1127
Conditions: Advanced Adenocarcinoma of the Colon or Rectum
Keywords: Advanced colon cancer, Advanced rectal cancer, Metastatic colon cancer, Metastatic rectal cancer, Lipitor, Atorvastatin, FOLFIRI
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Study was withdrawn due to lack of patient enrollment.
Enrolment: 0 participants (actual)
Lead sponsor: UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
Study start: Apr 2012
Primary completion: Jul 2013 (estimated)
Study completion: Jul 2014 (estimated)
First posted: 24 May 2012 (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.

Detailed description

Patients will be followed until Day 1 of Cycle 2 of FOLFIRI. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the event(s).

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Drug: FOLFIRI., Drug: AtorvastatinARM A subjects will receive atorvastatin 20 mg orally once daily given for two weeks prior to FOLFIRI. The last dose of atorvastatin will be taken day 1 of FOLFIRI. ARM A will then receive no statin for the next 2 weeks. Patients will receive FOLFIRI infusion on day 1 and day 15. Blood samples will be collected at baseline and periodically through 24 hours on day 1 and 15 of FOLFIRI.
Arm B	Experimental	Drug: FOLFIRI., Drug: AtorvastatinARM B subjects will receive no atorvastatin prior to day 1 of FOLFIRI. ARM B subjects will receive atorvastatin 20 mg orally once daily for two weeks prior to day 15 of FOLFIRI. The last dose of atorvastatin will be taken day 15 of FOLFIRI. Patients will receive FOLFIRI infusion on day 1 and day 15. Blood samples will be collected at baseline and periodically through 24 hours on day 1 and 15 of FOLFIRI.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age ≥18 years of age (no upper age limit)
Histological or cytological documentation of adenocarcinoma of the colon or rectum, and patient scheduled to begin FOLFIRI for treatment of their metastatic disease
Patients taking statins at the time of enrollment are permitted. Patients taking statins (or one of the prohibited drugs, see section 4.2.27 and section 12.1) must agree to a 2 week washout prior to treatment with atorvastatin (see Schema) and section 5.2
Life expectancy of at least 3 months
Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Key exclusion criteria (29 listed)

Any prior allergies to statin therapy or adverse events that precluded further use, including but not limited to myopathy, rhabdomyolysis, etc. Patients who had to change from atorvastatin to another statin for safety or efficacy reasons will also be excluded.
Prior treatment with FOLFIRI or single agent irinotecan is prohibited within six weeks of enrollment. All prior toxicity from previous irinotecan administration must be resolved prior to enrollment. No more than 2 prior therapeutic regimens for metastatic disease are allowed.
Patients will not be allowed to receive bevacizumab or EGFR inhibitors (cetuximab or panitumumab) for the duration of the study (1 cycle).
Patients with baseline LDL ≤ 100 mg/dL who are not currently treated with statins
Patients homozygous for the UGT1A1*28 allele, and patients of Asian descent homozygous or heterozygous for the UGT1A1*6 allele will be excluded due to their altered irinotecan metabolism

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
FOLFIRI.Also: 5-fluorouracil + leucovorin + irinotecanAll patients will receive FOLFIRI infusion on day 1 and day 15.	Drug	Arm A, Arm B
AtorvastatinAlso: LipitorA subjects will receive atorvastatin 20 mg orally once daily given for two weeks starting on Day -14 during PERIOD ONE. ARM A will then receive no statin during PERIOD TWO. ARM B subjects will receive no atorvastatin during PERIOD ONE. ARM B subjects will receive atorvastatin 20 mg orally once daily for two weeks during PERIOD TWO (starting on Day 2). One cycle = 28 days.	Drug	Arm A, Arm B

Primary outcome

Area under the plasma concentration versus time curve (AUC) of irinotecan.
Time frame: Blood samples will be collected on day 1 and 15 of FOLFIRI prior to treatment with irinotecan (baseline), immediately following the end of the irinotecan infusion, and at 0.5, 1, 1.5, 2, 4, 6, and 24 hours following the end of the irinotecan infusion.
At the end of the screening period, eligible patients will be randomly assigned in a 1:1 ratio to receive atorvastatin prior to Day 1 of FOLFIRI (ARM A) or atorvastatin prior to Day 15 FOLFIRI (ARM B). Patients in ARM A must start atorvastatin within 28 days of randomization and patients in ARM B should receive FOLFIRI within 28 days of randomization; if not, the Investigator must be notified.

1 secondary outcome

Area under the plasma concentration versus time curve (AUC) of SN-38.
Time frame: Blood samples will be collected on day 1 and 15 of FOLFIRI prior to treatment with irinotecan (baseline), immediately following the end of the irinotecan infusion, and at 0.5, 1, 1.5, 2, 4, 6, and 24 hours following the end of the irinotecan infusion.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
Website for UNC Lineberger Comprehensive Cancer CenterLink provided by the sponsor.

Related trials for Advanced Adenocarcinoma of the Colon or Rectum

RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

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.

Autumn McRee, MD principal investigator

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FOLFIRI. and Atorvastatin in people with Advanced Adenocarcinoma of the Colon or Rectum, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 10 inclusion and 29 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: withdrawn, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.

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?

Area under the plasma concentration versus time curve (AUC) of irinotecan. (time frame: Blood samples will be collected on day 1 and 15 of FOLFIRI prior to treatment with irinotecan (baseline), immediately following the end of the irinotecan infusion, and at 0.5, 1, 1.5, 2, 4, 6, and 24 hours following the end of the irinotecan infusion.). 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 NCT01605344.

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 Feb 2014.