Colon CancerPhase 2PRECEPTNCT00411450

Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment

A Phase 2 study testing Panitumumab and FOLFIRI in people with Colon Cancer and Colorectal Cancer, run by Amgen.

Completed

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

Trial summary

The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colon Cancer, Colorectal Cancer, Rectal Cancer
What is being tested?: Panitumumab and FOLFIRI
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: No sites listed yet
Study dates: Nov 2006to Oct 2010
Phase: Phase 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

Diagnosis of metastatic adenocarcinoma of the colon or rectum
Available paraffin-embedded tumor tissue
Failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mCRC
Measurable disease
Adequate hematologic, renal, hepatic and metabolic function

Who cannot join

Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
Prior irinotecan therapy, anti epidermal growth factor receptor (EGFr) therapy, or vaccine for the treatment of mCRC
CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior to Day 1 of Cycle 1
Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of Cycle 1
Clinically significant cardiovascular disease

Show all 12Show fewer

History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to Day 1 of Cycle 1
Any significant bleeding ≤ 6 weeks prior to Day 1 of Cycle 1, per the investigator's judgement
Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1
Any co-morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
Major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤ 4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery and have no significant complications

About this study

Official title: Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer

Conditions: Colon Cancer, Colorectal Cancer, Rectal Cancer, Cancer, Metastatic Cancer, Metastatic Colorectal Cancer
Being tested: Panitumumab, FOLFIRI
Keywords: k-ras, biomarker, colorectal, colon, rectal, FOLFOX, FOLFIRI
Medical subject headings: Colonic Neoplasms, Colorectal Neoplasms, Rectal Neoplasms, Neoplasms, Neoplasm Metastasis

What participants receive

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

PanitumumabBiological
Also called Vectibix
Administered by intravenous infusion
FOLFIRIDrug
Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.

Study groups in NCT00411450
Study group	Role	What they receive
Panitumumab plus FOLFIRI	Experimental	Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal. Receives: Biological: Panitumumab; Drug: FOLFIRI

What is being measured

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

Objective Response Rate at Weeks 17 and 25
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no radiographic tumor assessment(s) at Week 17 or 25 were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.
Measured: Week 17 and Week 25
Best Response During Second-Line Treatment
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response based on investigator review of scans using modified RECIST criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no post-baseline radiographic tumor assessment(s) were considered non-responders.
CR: disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or PD and no new lesions.
Measured: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Progression-free Survival Rate at Weeks 17 and 25
The progression-free survival rate is defined as the Kaplan-Meier (KM) estimator of progression-free survival at Week 17 and Week 25 reported as the probability of being event (disease progression or death)-free. Tumor assessments were evaluated by the investigator according to modified RECIST criteria.
PD: At least a 20% increase in the size of target lesions since the treatment started or at least a 25% increase in the size of non-target lesions and the lesion(s) measure ≥ 10 mm, or the appearance of any new lesions. Participants who withdraw from the study prior to completion of Week 17 or 25 radiographic tumor assessments were censored at the last evaluable tumor assessment.
Measured: Week 17 and Week 25
Progression-free Survival Time
Progression-free survival time was defined as the time from Study Day 1 to the date of disease progression (based on investigator assessment) or the date of death due to any cause. Participants who terminated from the study early (eg, prior to disease progression due to fully withdrawn informed consent) were censored at their last tumor assessment.
Measured: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Disease Control Rate at Weeks 17 and 25
The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST criteria as assessed by the investigator. Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline.
Measured: Week 17 and Week 25
Duration of Response
Duration of response is defined as the time from the date of first response to the date of first progression of disease during second-line treatment (as evaluated by the investigator) or death (if the death was due to disease progression but not detected earlier) in the subset of participants who responded (CR or PR, as evaluated by the investigator). Duration of response was analyzed using Kaplan-Meier methods; participants who responded but did not progress while on study were censored at the date of last tumor assessment.
Measured: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Overall Survival
Overall survival is defined as as the number of days from Study Day 1 to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were lost to follow-up or who had not died at the end of the study (52 weeks after the last participant was enrolled) were censored at the date of last contact.
Measured: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Time to Treatment Failure
Time to failure of second-line treatment is defined as the time from study Day 1 to the date of the earliest of the following events: end of second-line therapy due to any reason except for complete response and curative surgery; progressive disease; or death due to any cause. Time to treatment failure was analyzed using Kaplan-Meier methods; participants who did not discontinue second-line treatment or discontinue due to complete response or curative surgery, who were still alive, and who did not have disease progression were censored at the date of the last contact.
Measured: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Time to Progression
Time to progression is defined as the time from study Day 1 to the date of observed disease progression. Time to progression was analyzed using Kaplan-Meier methods; participants who did not have disease progression were censored at the date of last evaluable tumor assessment.
Measured: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Time to Response
Time to response of second-line treatment is defined as the time from study Day 1 to the date of first documentation of CR or PR, calculated for those participants with an objective tumor response of CR or PR.
Measured: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.

Secondary outcomes (3)

Number of Participants With Adverse Events
The severity of adverse events (AEs) was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, except for panitumumab related skin toxicities, where Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The relationship of each adverse event to the panitumumab and/or FOLFIRI regimen was assessed by the investigator. A serious adverse event was defined as an adverse event that • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard.
Measured: From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
Number of Participants With Grade 4 Laboratory Toxicities
Laboratory toxicities were graded according to CTCAE version 3.
Measured: From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
Number of Participants Who Developed Antibodies to Panitumumab
The immunogenicity of panitumumab was evaluated using 2 different screening immunoassays for the detection of anti-panitumumab antibodies: an acid dissociation bridging enzyme-linked immunosorbent assay (ELISA; detecting high-affinity antibodies) and a Biacore® biosensor immunoassay (detecting both high and low-affinity antibodies). When either of the 2 screening assays yielded a positive result, that particular sample was subjected to an in vitro bioassay for the detection of neutralizing antibodies.
Measured: Prior to first dose and 28 days after the last dose of second-line treatment

Timeline

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

Nov 2006Oct 2010

First posted14 Dec 2006 (estimated)
Study startNov 2006
Primary completionJan 2009
Study completionOct 2010

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Colon CancerStudies of the same condition, open and under way.
More trials run by AmgenThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00411450
Sponsor's protocol ID: 20060277
Acronym: PRECEPT
Status last verified: Jan 2016
First submitted: 12 Dec 2006
Last updated: 15 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cohn AL, Shumaker GC, Khandelwal P, Smith DA, Neubauer MA, Mehta N, Richards D, Watkins DL, Zhang K, Yassine MR. An open-label, single-arm, phase 2 trial of panitumumab plus FOLFIRI as second-line therapy in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2011 Sep;10(3):171-7. doi: 10.1016/j.clcc.2011.03.022. Epub 2011 Apr 28.
PubMed 21855038
Weeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Perez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M. Immunogenicity of panitumumab in combination chemotherapy clinical trials. BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17.
PubMed 22070868

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?

Official record

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All Colon Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi Center, Open Label, Single Arm Trial Evaluating Panitumumab in Combination With FOLFIRI Therapy Following First Line FOLFOX and Bevacizumab Treatment of Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT00411450
Acronym / sponsor ID: PRECEPT / 20060277
Conditions: Colon Cancer, Colorectal Cancer, Rectal Cancer, Cancer, Metastatic Cancer, Metastatic Colorectal Cancer
Keywords: k-ras, biomarker, colorectal, colon, rectal, FOLFOX, FOLFIRI
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Jan 2009 (actual)
Study completion: Oct 2010 (actual)
First posted: 14 Dec 2006 (estimated)
Results: Posted 15 Feb 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Panitumumab plus FOLFIRI	Experimental	Biological: Panitumumab, Drug: FOLFIRIParticipants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.

Who may qualify

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

Key inclusion criteria (5 listed)

Diagnosis of metastatic adenocarcinoma of the colon or rectum
Available paraffin-embedded tumor tissue
Failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mCRC
Measurable disease
Adequate hematologic, renal, hepatic and metabolic function

Key exclusion criteria (12 listed)

Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
Prior irinotecan therapy, anti epidermal growth factor receptor (EGFr) therapy, or vaccine for the treatment of mCRC
CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior to Day 1 of Cycle 1
Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of Cycle 1

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
PanitumumabAlso: VectibixAdministered by intravenous infusion	Biological	Panitumumab plus FOLFIRI
FOLFIRIChemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.	Drug	Panitumumab plus FOLFIRI

Primary outcome

Objective Response Rate at Weeks 17 and 25
Time frame: Week 17 and Week 25
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response. Disease assessments were based on investigator review of scans using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no radiographic tumor assessment(s) at Week 17 or 25 were considered non-responders. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.
Best Response During Second-Line Treatment
Time frame: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Objective response rate is defined as the percentage of participants with a best response of complete response or partial response based on investigator review of scans using modified RECIST criteria. A complete or partial response was confirmed no less than 4 weeks after the criteria for response were first met. Participants with no post-baseline radiographic tumor assessment(s) were considered non-responders. CR: disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions (defined as a ≥ 25% increase in lesion size) and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or PD and no new lesions.
Progression-free Survival Rate at Weeks 17 and 25
Time frame: Week 17 and Week 25
The progression-free survival rate is defined as the Kaplan-Meier (KM) estimator of progression-free survival at Week 17 and Week 25 reported as the probability of being event (disease progression or death)-free. Tumor assessments were evaluated by the investigator according to modified RECIST criteria. PD: At least a 20% increase in the size of target lesions since the treatment started or at least a 25% increase in the size of non-target lesions and the lesion(s) measure ≥ 10 mm, or the appearance of any new lesions. Participants who withdraw from the study prior to completion of Week 17 or 25 radiographic tumor assessments were censored at the last evaluable tumor assessment.
Progression-free Survival Time
Time frame: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Progression-free survival time was defined as the time from Study Day 1 to the date of disease progression (based on investigator assessment) or the date of death due to any cause. Participants who terminated from the study early (eg, prior to disease progression due to fully withdrawn informed consent) were censored at their last tumor assessment.
Disease Control Rate at Weeks 17 and 25
Time frame: Week 17 and Week 25
The percentage of participants whose best response was either a complete or partial response or stable disease, based on modified RECIST criteria as assessed by the investigator. Stable diease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD of target lesions and no progression of existing non-target lesions and no new lesions, or, the persistence of 1 or more non-target lesions not qualifying for either CR or PD if no target lesions were identified at Baseline.
Duration of Response
Time frame: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Duration of response is defined as the time from the date of first response to the date of first progression of disease during second-line treatment (as evaluated by the investigator) or death (if the death was due to disease progression but not detected earlier) in the subset of participants who responded (CR or PR, as evaluated by the investigator). Duration of response was analyzed using Kaplan-Meier methods; participants who responded but did not progress while on study were censored at the date of last tumor assessment.
Overall Survival
Time frame: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Overall survival is defined as as the number of days from Study Day 1 to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were lost to follow-up or who had not died at the end of the study (52 weeks after the last participant was enrolled) were censored at the date of last contact.
Time to Treatment Failure
Time frame: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Time to failure of second-line treatment is defined as the time from study Day 1 to the date of the earliest of the following events: end of second-line therapy due to any reason except for complete response and curative surgery; progressive disease; or death due to any cause. Time to treatment failure was analyzed using Kaplan-Meier methods; participants who did not discontinue second-line treatment or discontinue due to complete response or curative surgery, who were still alive, and who did not have disease progression were censored at the date of the last contact.
Time to Progression
Time frame: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.
Time to progression is defined as the time from study Day 1 to the date of observed disease progression. Time to progression was analyzed using Kaplan-Meier methods; participants who did not have disease progression were censored at the date of last evaluable tumor assessment.
Time to Response
Time frame: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.
Time to response of second-line treatment is defined as the time from study Day 1 to the date of first documentation of CR or PR, calculated for those participants with an objective tumor response of CR or PR.

3 secondary outcomes

Number of Participants With Adverse Events
Time frame: From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
Number of Participants With Grade 4 Laboratory Toxicities
Time frame: From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months.
Number of Participants Who Developed Antibodies to Panitumumab
Time frame: Prior to first dose and 28 days after the last dose of second-line treatment

Results and safety

Results posted to the registry on 15 Feb 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
Panitumumab Plus FOLFIRI	116	113

Primary outcome: Objective Response Rate at Weeks 17 and 25

Time frame: Week 17 and Week 25. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Wild-type KRAS n = 64	Mutant KRAS n = 43
Week 17	20 (10 to 30)	14 (4 to 24)
Week 25	22 (12 to 32)	14 (4 to 24)

Wild-type KRAS vs Mutant KRAS: Difference: 6 (95% CI -11 to 21)
Wild-type KRAS vs Mutant KRAS: Difference: 8 (95% CI -9 to 23)

Population analysed: Tumor Response Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, who had valid KRAS mutation status data available and with at least 1 uni-dimensionally measurable lesion per the local investigator)

Primary outcome: Best Response During Second-Line Treatment

Time frame: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Wild-type KRAS n = 64	Mutant KRAS n = 43
Value	23 (13 to 34)	16 (5 to 27)

Wild-type KRAS vs Mutant KRAS: Difference: 7 (95% CI -11 to 23)

Population analysed: Tumor Response Analysis Set

Primary outcome: Progression-free Survival Rate at Weeks 17 and 25

Time frame: Week 17 and Week 25. Number (95% Confidence Interval). Unit: percent probability

Measure	Wild-type KRAS n = 64	Mutant KRAS n = 45
Week 17	67 (54 to 77)	55 (39 to 68)
Week 25	52 (39 to 64)	41 (27 to 55)

Wild-type KRAS vs Mutant KRAS: Difference: 12.5 (95% CI -6.3 to 31.4)
Wild-type KRAS vs Mutant KRAS: Difference: 10.9 (95% CI -8.4 to 30.2)

Population analysed: Primary Analysis Set (all participants who provided informed consent prior to the initiation of any study specific procedures, received at least 1 dose of panitumumab, and who had valid KRAS mutation status data available)

Primary outcome: Progression-free Survival Time

Time frame: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks.. Median (95% Confidence Interval). Unit: weeks

Measure	Wild-type KRAS n = 64	Mutant KRAS n = 45
Value	26 (19 to 33)	19 (12 to 25)

Wild-type KRAS vs Mutant KRAS: Hazard Ratio (HR): 0.8 (95% CI 0.5 to 1.1)

Population analysed: Primary Analysis Set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The time frame for adverse event reporting is from the first dose date to 30 days since the last dose date. The median time frame is 4.5 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Panitumumab + FOLFIRI	46 of 115 (40%)	114 of 115 (99.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21855038Cohn AL, Shumaker GC, Khandelwal P, Smith DA, Neubauer MA, Mehta N, Richards D, Watkins DL, Zhang K, Yassine MR. An open-label, single-arm, phase 2 trial of panitumumab plus FOLFIRI as second-line therapy in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2011 Sep;10(3):171-7. doi: 10.1016/j.clcc.2011.03.022. Epub 2011 Apr 28.
Derived from this study: PubMed 22070868Weeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Perez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M. Immunogenicity of panitumumab in combination chemotherapy clinical trials. BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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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.

MD study director

Amgen

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab and FOLFIRI in people with Colon Cancer and Colorectal Cancer, run by Amgen.

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 12 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

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 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 15 Feb 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?

Objective Response Rate at Weeks 17 and 25 (time frame: Week 17 and Week 25). The study lists 10 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 NCT00411450, which also lists 2 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 15 Feb 2016.