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NCT00418938

SPIRITT - Second-Line Panitumumab Irinotecan Treatment Trial

Completed Phase 2 Results posted Last updated 17 October 2018
What this trial tests

Phase 2 trial testing Panitumumab in Cancer in 266 participants. Completed in 1 April 2013.

Timeline
1 November 2006
Primary endpoint
10 May 2012
1 April 2013

Quick facts

Lead sponsorAmgen
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment266
Start date1 November 2006
Primary completion10 May 2012
Estimated completion1 April 2013

Drugs / interventions tested

Conditions studied

Sponsor

Amgen — full company profile →

Who can join

18 and older, any sex, with Cancer or Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-free Survival (PFS) Primary · From randomization up to 65 months.

Progression-free survival is defined as time from the date of randomization to the date of first progression per modified RECIST version 1.0 (based on central review of the radiographic scans), or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later).

Wild-type KRAS (n=91,91)
GroupValue95% CI
Panitumumab Plus FOLFIRI7.75.7 – 11.8
Bevacizumab Plus FOLFIRI9.27.8 – 10.6
Mutant KRAS (n=36,32)
GroupValue95% CI
Panitumumab Plus FOLFIRI3.72.7 – 5.5
Bevacizumab Plus FOLFIRI6.43.5 – 17.1
Overall Survival Secondary · From randomization up to 65 months.

Overall survival is defined as time from the date of randomization to the date of death due to any cause. Subjects who have not died or are lost to follow-up at the analysis cutoff date will be censored at their last contact date.

Wild-type KRAS (n=91,91)
GroupValue95% CI
Panitumumab Plus FOLFIRI18.013.5 – 21.7
Bevacizumab Plus FOLFIRI21.416.5 – 24.6
Mutant KRAS (n=36,32)
GroupValue95% CI
Panitumumab Plus FOLFIRI8.76.1 – 14.5
Bevacizumab Plus FOLFIRI13.59.1 – 14.3
Objective Response Rate Secondary · From randomization up to 65 months.

Objective response rate is defined as incidence of either a confirmed complete response (CR) or partial response (PR) on study up to starting a new anti-tumor therapy and will be based on modified RECIST version 1.0 (responder) by central assessment.

Wild-type KRAS (n=91,91)
GroupValue95% CI
Panitumumab Plus FOLFIRI32.1822.56 – 43.06
Bevacizumab Plus FOLFIRI19.2811.44 – 29.41
Mutant KRAS (n=36,32)
GroupValue95% CI
Panitumumab Plus FOLFIRI11.763.30 – 27.45
Bevacizumab Plus FOLFIRI3.330.08 – 17.22
Time to Response Secondary · From randomization up to 65 months.

Time to response is defined as time from the date of randomization to the date of first confirmed objective response

Wild-type KRAS (n=91,91)
GroupValue95% CI
Panitumumab Plus FOLFIRI2.11.8 – 3.9
Bevacizumab Plus FOLFIRI3.72.0 – 4.0
Mutant KRAS (n=36,32)
GroupValue95% CI
Panitumumab Plus FOLFIRI2.22.0 – 2.3
Bevacizumab Plus FOLFIRI1.81.8 – 1.8
Time to Progression Secondary · From randomization up to 65 months.

Time to progression is defined as time from the date of randomization to the date of radiographic disease progression per modified RECIST version 1.0 (per central assessment).

Wild-type KRAS
GroupValue95% CI
Panitumumab Plus FOLFIRI11.17.5 – 13.2
Bevacizumab Plus FOLFIRI9.48.2 – 11.9
Mutant KRAS
GroupValue95% CI
Panitumumab Plus FOLFIRI4.53.0 – 12.0
Bevacizumab Plus FOLFIRI7.45.7 – 19.2
Disease Control Secondary · From randomization up to 65 months.

Disease control is defined as incidence of objective response or stable disease on study up to starting a new anti-tumor therapy.

Wild-type KRAS (n=91,91)
GroupValue95% CI
Panitumumab Plus FOLFIRI72.4161.79 – 81.46
Bevacizumab Plus FOLFIRI79.5269.24 – 87.59
Mutant KRAS (n=36,32)
GroupValue95% CI
Panitumumab Plus FOLFIRI52.9435.13 – 70.22
Bevacizumab Plus FOLFIRI66.6747.19 – 82.71
Duration of Response Secondary · From randomization up to 65 months.

Duration of response is defined as time from first confirmed objective response to disease progression per modified RECIST version 1.0 (by central assessment).

Wild-type KRAS (n=91,91)
GroupValue95% CI
Panitumumab Plus FOLFIRI12.77.9 – 19.1
Bevacizumab Plus FOLFIRI8.96.5 – 13.6
Mutant KRAS (n=36,32)
GroupValue95% CI
Panitumumab Plus FOLFIRI10.29.8 – 13.5
Bevacizumab Plus FOLFIRI15.2NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: The median reporting period was since randomization date to 65 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Panitumumab Plus FOLFIRI
Serious: 61/133 (46%)
Deaths: —
Bevacizumab Plus FOLFIRI
Serious: 39/131 (30%)
Deaths: —

Serious adverse events (104 terms)

ReactionSystemPanitumumab Plus FOLFIRIBevacizumab Plus FOLFIRI
DiarrhoeaGastrointestinal disorders——
Pulmonary embolismRespiratory, thoracic and mediastinal disorders——
DehydrationMetabolism and nutrition disorders——
VomitingGastrointestinal disorders——
Abdominal painGastrointestinal disorders——
Small intestinal obstructionGastrointestinal disorders——
NeutropeniaBlood and lymphatic system disorders——
NauseaGastrointestinal disorders——
SepsisInfections and infestations——
Urinary tract infectionInfections and infestations——
Deep vein thrombosisVascular disorders——
AnaemiaBlood and lymphatic system disorders——
Febrile neutropeniaBlood and lymphatic system disorders——
ThrombocytopeniaBlood and lymphatic system disorders——
Intestinal obstructionGastrointestinal disorders——
Rectal ulcerGastrointestinal disorders——
StomatitisGastrointestinal disorders——
AstheniaGeneral disorders——
Mucosal inflammationGeneral disorders——
PyrexiaGeneral disorders——
Septic shockInfections and infestations——
Failure to thriveMetabolism and nutrition disorders——
HypomagnesaemiaMetabolism and nutrition disorders——
Back painMusculoskeletal and connective tissue disorders——
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Other adverse events (66 terms — click to expand)

ReactionSystemPanitumumab Plus FOLFIRIBevacizumab Plus FOLFIRI
DiarrhoeaGastrointestinal disorders——
NauseaGastrointestinal disorders——
FatigueGeneral disorders——
RashSkin and subcutaneous tissue disorders——
NeutropeniaBlood and lymphatic system disorders——
VomitingGastrointestinal disorders——
HypomagnesaemiaMetabolism and nutrition disorders——
ConstipationGastrointestinal disorders——
HypokalaemiaMetabolism and nutrition disorders——
StomatitisGastrointestinal disorders——
Decreased appetiteMetabolism and nutrition disorders——
Abdominal painGastrointestinal disorders——
Dermatitis acneiformSkin and subcutaneous tissue disorders——
Mucosal inflammationGeneral disorders——
Weight decreasedInvestigations——
AnaemiaBlood and lymphatic system disorders——
EpistaxisRespiratory, thoracic and mediastinal disorders——
DehydrationMetabolism and nutrition disorders——
AlopeciaSkin and subcutaneous tissue disorders——
PyrexiaGeneral disorders——
InsomniaPsychiatric disorders——
DyspnoeaRespiratory, thoracic and mediastinal disorders——
ThrombocytopeniaBlood and lymphatic system disorders——
Neuropathy peripheralNervous system disorders——
HypotensionVascular disorders——
AstheniaGeneral disorders——
Dry skinSkin and subcutaneous tissue disorders——
Oedema peripheralGeneral disorders——
DizzinessNervous system disorders——
PruritusSkin and subcutaneous tissue disorders——
Skin fissuresSkin and subcutaneous tissue disorders——
Upper respiratory tract infectionInfections and infestations——
Urinary tract infectionInfections and infestations——
Back painMusculoskeletal and connective tissue disorders——
CoughRespiratory, thoracic and mediastinal disorders——
LeukopeniaBlood and lymphatic system disorders——
ParonychiaInfections and infestations——
DyspepsiaGastrointestinal disorders——
Pain in extremityMusculoskeletal and connective tissue disorders——
Nail disorderSkin and subcutaneous tissue disorders——

Most-reported serious reactions: Diarrhoea, Pulmonary embolism, Dehydration, Vomiting, Abdominal pain, Small intestinal obstruction, Neutropenia, Nausea.

Data from ClinicalTrials.gov NCT00418938 adverse events section.

Sponsor's own description

This is a multi-center, open-label, randomized, phase 2, two-arm clinical trial to be conducted in the United States. Approximately 210 eligible KRAS wild-type expressing metastatic colorectal cancer subjects who have failed first-line oxaliplatin-based chemotherapy (with at least 4 doses of oxaliplatin-based chemotherapy) with at least 4 doses of bevacizumab (failure is defined as toxicity due to oxaliplatin-based chemotherapy or progression of disease on first-line treatment) will be randomized in a 1:1 ratio to receive either a once-every-two-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg or a Q2W FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.
    Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, et al · · 2016 · cited 42× · PMID 26992001 · DOI 10.1111/bcp.12940
  2. The impact of panitumumab treatment on survival and quality of life in patients with <i>RAS</i> wild-type metastatic colorectal cancer.
    Battaglin F, Puccini A, Ahcene Djaballah S, Lenz HJ. · · 2019 · cited 23× · PMID 31388315 · DOI 10.2147/cmar.s186042
  3. Panitumumab in Metastatic Colorectal Cancer: The Importance of Tumour RAS Status.
    Peeters M, Karthaus M, Rivera F, Terwey JH, et al · · 2015 · cited 18× · PMID 25895463 · DOI 10.1007/s40265-015-0386-x
  4. Chemotherapy plus Panitumumab Versus Chemotherapy plus Bevacizumab in Metastatic Colorectal Cancer: A Meta-analysis.
    Li Z, Huang Y, Zhao R, Cui Y, et al · · 2018 · cited 3× · PMID 29323221 · DOI 10.1038/s41598-017-19001-6

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