Metastatic Colorectal CancerPhase 1/2NCT01085331
MEK Inhibitor MSC1936369B Plus FOLFIRI in Second Line K-Ras Mutated Metastatic Colorectal Cancer (mCRC)
A Phase 1/2 study testing Pimasertib and FOLFIRI in people with Metastatic Colorectal Cancer, run by EMD Serono at 3 sites in 3 countries.
Trial summary
The research trial is testing the experimental treatment pimasertib (MSC1936369B) in combination with FOLFIRI, as second-line treatment in metastatic K Ras mutated colorectal cancer subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Pimasertib and FOLFIRI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2010to Apr 2012
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Safety Run-in and Part 2 or Phase 2 Randomised Part
- Histologically confirmed K-Ras mutated colon/rectum cancer
- Subject's disease must have progressed during or after a first-line treatment for metastatic disease with oxaliplatin and fluoropyrimidines based chemotherapy with or without bevacizumab
- Evidence of metastatic measurable disease at trial entry as per Response Evaluation Criteria in Solid Tumors. Complete tumor assessment performed within 14 days prior to first trial drug administration
- Male/female subjects aged greater than or equal to (>=) 18 years
- Subject has read and understood the informed consent form
- Women of childbearing potential must have a negative blood pregnancy test at the screening visit. Subjects and their partners must be willing to avoid pregnancy during the trial
Who cannot join
- For Safety Run-in and Part 2 or Phase 2 Randomised Part
- Bone marrow impairment
- Renal impairment
- Liver function and liver cell integrity abnormality
- History of central nervous system (CNS) metastases
- History of difficulty of swallowing, malabsorption or other chronic gastrointestinal disease
Show all 18Show fewer
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than (>)1
- Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B
- Has received extensive prior radiotherapy on more than 30 percent (%) of bone marrow reserves, or prior bone marrow/stem cell transplantation
- Has received chemotherapy, any investigational drug, or having participated in another clinical trial within the past 4 weeks prior to trial first drug administration
- Has a history of any other significant medical disease
- Past or current history (within the last 2 years prior to inclusion) of malignancies except for the indication under this study
- Has significant cardiac conduction abnormalities and/or pacemaker
- Is a pregnant or nursing female
- Has retinal degenerative disease, history of uveitis, or history of retinal vein occlusion
- Other significant disease that in the Investigator's opinion would exclude the subject from the trial
- Known hypersensitivity to the trial treatment(s) or diluents (when applicable), including placebo or other comparator drug(s)
- Legal incapacity or limited legal capacity
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Double-blind, Randomized, Comparative, Multicenter, Exploratory, and Placebo-controlled Phase II Trial of FOLFIRI Plus MSC1936369B or Placebo With a Safety run-in Part as Second-line Treatment of Metastatic K Ras Mutated Colorectal Cancer Subjects
The research trial is testing the experimental treatment pimasertib (MSC1936369B) in combination with FOLFIRI, as second-line treatment in metastatic K Ras mutated colorectal cancer subjects. The study will be run in two parts:
Part 1, or Safety Run-in Part: Will determine the maximum tolerated dose and the recommended Phase 2 dose (RP2D) of pimasertib combined with FOLFIRI as second-line treatment in subjects with metastatic K Ras mutated colorectal cancer.
Read more
Part 2 or Phase 2 Randomised Part: Will assess the anti-tumor activity of pimasertib combined with FOLFIRI compared to FOLFIRI with placebo as second-line treatment in metastatic K Ras mutated colorectal cancer subjects.
Phase I which Is an open label dose escalation "3+3" cohort, non-randomized, safety Phase II which is a double blind randomized safety/efficacy
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Pimasertib, Placebo, FOLFIRI
- Keywords
- Mek Inhibitor, Metastatic Colorectal Cancer, K-Ras Mutation, Phase II, Second line K-Ras mutated metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimasertibDrug
Also called MSC1936369B
Subjects will be administered with pimasertib orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle.
PlaceboDrug
Subjects will be administered with placebo orally once daily on days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle.
FOLFIRIDrug
Subjects will be administered with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 or Safety Run-in Part: Pimasertib+FOLFIRI | Experimental | Not described Receives: Drug: Pimasertib; Drug: FOLFIRI |
| Part 2 or Phase 2 Randomized part: Pimasertib+FOLFIRI | Experimental | Planned, not performed Receives: Drug: Pimasertib; Drug: FOLFIRI |
| Part 2 or Phase 2 Randomized part: Placebo+FOLFIRI | Experimental | Planned, not performed Receives: Drug: Placebo; Drug: FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 or Safety Run-in Part: Maximum Tolerated Dose (MTD)
MTD was defined as the dose level, at which the treatment-related dose limiting toxicity (DLT) occurred in >1 of 3 subjects or in >1 of 6 subjects. DLT was defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Any Grade >=3 non-hematological toxicity except for Grade 4 asymptomatic increases in liver function tests (LFTs) reversible within 7 days in subjects with liver involvement, Grade 3 asymptomatic increases in LFTs reversible within 7 days in subjects without liver involvement, Grade 3 vomiting controlled with adequate and optimal therapy and prophylaxis, and Grade 3 diarrhea controlled with adequate and optimal anti-diarrhea therapy; any Grade 4 neutropenia lasing >5 days/ febrile neutropenia lasting >1 day; any Grade 4 thrombocytopenia/Grade 3 with bleeding; any treatment delay >2 weeks due to trial treatment-related adverse effects at any dose level and judged to be possibly or probably related to the trial treatment.
Measured: Baseline up to Day 28 (Part 1)
Part 2 or Phase 2 Randomised Part: Progression Free Survival (PFS)
PFS was defined as time (in months) from the date of randomization to the first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST v1.0) or death for any cause.
Measured: From randomization up to first documented disease progression maximum up to 2 years
Secondary outcomes (15)
Part 1 or Safety Run-in Part: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: From the first dose of study drug administration up to 28 days after the last dose of study drug administration
Part 1 or Safety Run-in Part: Maximum Observed Plasma Concentration (Cmax) of Pimasertib, Irinotecan and SN-38
Measured: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Time to Reach Maximum Observed Concentration (Tmax) of Pimasertib, Irinotecan and SN-38
Measured: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to the Time of Last Observation (AUC0-t) of Pimasertib, Irinotecan and SN-38
Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration is at or above the lower limit of quantification.
Measured: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib, Irinotecan and SN-38
The AUC(0-inf) of pimasertib and irinotecan was estimated by determining the total area under the concentration time curve extrapolated to infinity.
Measured: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Apparent Terminal Half Life (t1/2) of Pimasertib, Irinotecan and SN-38
The t1/2 was defined as the time required for the plasma concentration of pimasertib and irinotecan to decrease 50% in the final stage of elimination.
Measured: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Apparent Oral Clearance (CL/f) of Pimasertib, (CL) Irinotecan and SN-38
Clearance of a drug was a measure of the rate at which drug was metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.
Measured: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Apparent Oral Volume of Distribution (Vz f) Pimasertib, (Vz) of Irinotecan and SN-38
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.
Measured: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Ratio of Cmax for Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)
Measured: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Ratio of AUC0-inf of Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)
The AUC(0-inf) was estimated by determining the total area under the concentration time curve extrapolated to infinity.
Measured: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan
Part 1 or Safety Run-in Part: Number of Subjects With Best Overall Response (BOR)
BOR was defined based on Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST V1.0) as following: Complete response (CR) was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) was defined as at least a 30 percent (%) decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks (28 days). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) being demonstrated during the first 4 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.
Measured: Up to 2 years
Part 1 or Safety Run-in Part: Circulating Biomarkers in Serum
Measured: Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years
Part 2 or Phase 2 Randomized Part: Circulating Biomarkers
Measured: Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years
Part 2 or Phase 2 Randomized Part: Best Overall Response
BOR was defined based on Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST V1.0) as following: Complete response (CR) was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) was defined as at least a 30 percent (%) decrease in the sum of the longest diameters (SLD) of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks (28 days). Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) being demonstrated during the first 4 weeks. PD was defined as at least a 20% increase in the SLD of target lesions compared to the smallest SLD since the study treatment started.
Measured: Up to 2 years
Part 2 or Phase 2 Randomized Part: Number of Subjects With TEAEs, Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
An AE is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAES between first dose of study drug administration and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: From the first dose of study drug administration up to 28 days after the last dose of study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2012
- Study completionApr 2012
Why it stopped: Conduct the randomized Phase 2 part not recommended due to the achieved MTD for pimasertib (45mg/day) in combination with FOLFIRI
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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Serono S.A., Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085331
- Sponsor's protocol ID
- EMR200066_004
- Status last verified
- Aug 2016
- First submitted
- 4 Mar 2010
- Last updated
- 19 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Comparative, Multicenter, Exploratory, and Placebo-controlled Phase II Trial of FOLFIRI Plus MSC1936369B or Placebo With a Safety run-in Part as Second-line Treatment of Metastatic K Ras Mutated Colorectal Cancer Subjects
- ClinicalTrials.gov ID
- NCT01085331
- Acronym / sponsor ID
- EMR200066_004
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Mek Inhibitor, Metastatic Colorectal Cancer, K-Ras Mutation, Phase II, Second line K-Ras mutated metastatic colorectal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Conduct the randomized Phase 2 part not recommended due to the achieved MTD for pimasertib (45mg/day) in combination with FOLFIRI
- Enrolment
- 16 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Posted 19 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research trial is testing the experimental treatment pimasertib (MSC1936369B) in combination with FOLFIRI, as second-line treatment in metastatic K Ras mutated colorectal cancer subjects. The study will be run in two parts:
Part 1, or Safety Run-in Part: Will determine the maximum tolerated dose and the recommended Phase 2 dose (RP2D) of pimasertib combined with FOLFIRI as second-line treatment in subjects with metastatic K Ras mutated colorectal cancer.
Part 2 or Phase 2 Randomised Part: Will assess the anti-tumor activity of pimasertib combined with FOLFIRI compared to FOLFIRI with placebo as second-line treatment in metastatic K Ras mutated colorectal cancer subjects.
Phase I which Is an open label dose escalation "3+3" cohort, non-randomized, safety Phase II which is a double blind randomized safety/efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 or Safety Run-in Part: Pimasertib+FOLFIRI | Experimental | Drug: Pimasertib, Drug: FOLFIRI |
| Part 2 or Phase 2 Randomized part: Pimasertib+FOLFIRI | Experimental | Drug: Pimasertib, Drug: FOLFIRIPlanned, not performed |
| Part 2 or Phase 2 Randomized part: Placebo+FOLFIRI | Experimental | Drug: Placebo, Drug: FOLFIRIPlanned, not performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For Safety Run-in and Part 2 or Phase 2 Randomised Part
- Histologically confirmed K-Ras mutated colon/rectum cancer
- Subject's disease must have progressed during or after a first-line treatment for metastatic disease with oxaliplatin and fluoropyrimidines based chemotherapy with or without bevacizumab
- Evidence of metastatic measurable disease at trial entry as per Response Evaluation Criteria in Solid Tumors. Complete tumor assessment performed within 14 days prior to first trial drug administration
- Male/female subjects aged greater than or equal to (>=) 18 years
Key exclusion criteria (18 listed)
- For Safety Run-in and Part 2 or Phase 2 Randomised Part
- Bone marrow impairment
- Renal impairment
- Liver function and liver cell integrity abnormality
- History of central nervous system (CNS) metastases
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 |
|---|---|---|
| PimasertibAlso: MSC1936369BSubjects will be administered with pimasertib orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle. | Drug | Part 1 or Safety Run-in Part: Pimasertib+FOLFIRI, Part 2 or Phase 2 Randomized part: Pimasertib+FOLFIRI |
| PlaceboSubjects will be administered with placebo orally once daily on days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle. | Drug | Part 2 or Phase 2 Randomized part: Placebo+FOLFIRI |
| FOLFIRISubjects will be administered with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle. | Drug | Part 1 or Safety Run-in Part: Pimasertib+FOLFIRI, Part 2 or Phase 2 Randomized part: Pimasertib+FOLFIRI, Part 2 or Phase 2 Randomized part: Placebo+FOLFIRI |
Primary outcome
Part 1 or Safety Run-in Part: Maximum Tolerated Dose (MTD)
Time frame: Baseline up to Day 28 (Part 1)
MTD was defined as the dose level, at which the treatment-related dose limiting toxicity (DLT) occurred in >1 of 3 subjects or in >1 of 6 subjects. DLT was defined using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Any Grade >=3 non-hematological toxicity except for Grade 4 asymptomatic increases in liver function tests (LFTs) reversible within 7 days in subjects with liver involvement, Grade 3 asymptomatic increases in LFTs reversible within 7 days in subjects without liver involvement, Grade 3 vomiting controlled with adequate and optimal therapy and prophylaxis, and Grade 3 diarrhea controlled with adequate and optimal anti-diarrhea therapy; any Grade 4 neutropenia lasing >5 days/ febrile neutropenia lasting >1 day; any Grade 4 thrombocytopenia/Grade 3 with bleeding; any treatment delay >2 weeks due to trial treatment-related adverse effects at any dose level and judged to be possibly or probably related to the trial treatment.
Part 2 or Phase 2 Randomised Part: Progression Free Survival (PFS)
Time frame: From randomization up to first documented disease progression maximum up to 2 years
PFS was defined as time (in months) from the date of randomization to the first documentation of disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST v1.0) or death for any cause.
15 secondary outcomes
Part 1 or Safety Run-in Part: Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
Time frame: From the first dose of study drug administration up to 28 days after the last dose of study drug administration
Part 1 or Safety Run-in Part: Maximum Observed Plasma Concentration (Cmax) of Pimasertib, Irinotecan and SN-38
Time frame: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Time to Reach Maximum Observed Concentration (Tmax) of Pimasertib, Irinotecan and SN-38
Time frame: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to the Time of Last Observation (AUC0-t) of Pimasertib, Irinotecan and SN-38
Time frame: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib, Irinotecan and SN-38
Time frame: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Apparent Terminal Half Life (t1/2) of Pimasertib, Irinotecan and SN-38
Time frame: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Apparent Oral Clearance (CL/f) of Pimasertib, (CL) Irinotecan and SN-38
Time frame: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Apparent Oral Volume of Distribution (Vz f) Pimasertib, (Vz) of Irinotecan and SN-38
Time frame: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Ratio of Cmax for Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)
Time frame: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan and SN-38
Part 1 or Safety Run-in Part: Ratio of AUC0-inf of Pimasertib (Day 1/Day 8), Irinotecan and SN-38 (Day 1/Day 15)
Time frame: Day 1 and Day 8 for pimasertib; Day 1 and Day 15 for Irinotecan
Part 1 or Safety Run-in Part: Number of Subjects With Best Overall Response (BOR)
Time frame: Up to 2 years
Part 1 or Safety Run-in Part: Circulating Biomarkers in Serum
Time frame: Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years
Part 2 or Phase 2 Randomized Part: Circulating Biomarkers
Time frame: Predose, Day 1, 2 and 16 of cycle 1 followed by Day 1 pre-dose of every second cycle up to 2 years
Part 2 or Phase 2 Randomized Part: Best Overall Response
Time frame: Up to 2 years
Part 2 or Phase 2 Randomized Part: Number of Subjects With TEAEs, Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
Time frame: From the first dose of study drug administration up to 28 days after the last dose of study drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Responsible study director
Merck Serono S.A., Geneva
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pimasertib and FOLFIRI in people with Metastatic Colorectal Cancer, run by EMD Serono at 3 sites in 3 countries.
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 7 inclusion and 18 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 19 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 Belgium, Italy, Spain. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Oct 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?
Part 1 or Safety Run-in Part: Maximum Tolerated Dose (MTD) (time frame: Baseline up to Day 28 (Part 1)). 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?
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 19 Oct 2016.