An observational study in Advanced or Recurrent Colorectal Cancer, sponsored by Takeda. Completed. Per ClinicalTrials.gov, last updated 2017-04-06.
Sponsored by Takeda · Observational
The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.
Specifically, information will be collected on the following as events of interest: skin disorders, interstitial lung disease, infusion reactions, electrolyte abnormalities, and cardiac disorders.
The efficacy and safety of panitumumab (Vectibix) in the routine clinical setting will be studied.
Participants of this surveillance will be patients with unresectable, advanced or recurrent colorectal cancer with the wild-type KRAS gene. The planned sample size is 2,000 patients.
The usual adult dosage is 6 mg/kg of panitumumab given by intravenous drip infusion over a 60-minute period once every 2 weeks. The dosage may also be reduced as needed, depending on the patient's condition.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 3,091 is above the median of 250 across 1,253 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Takeda is the lead sponsor of 1,025 studies on the registry; 91 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS gene
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks
Drug: Panitumumab
Panitumumab for intravenous infusion
Also known as: Vectibix
Number of Participants With Adverse Drug Reactions
The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.
Time frame: Baseline through Week 42
Progression-free Survival
Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.
Time frame: Up to Week 42 or death (whichever occurred first)
Overall Survival
Overall survival was defined as the time to death from the start of panitumumab administration was tabulated.
Time frame: Up to Week 42 or death (whichever occurred first)
Participants enrolled during the period from June 1, 2010 to November 14, 2010 were surveyed.
| Milestone | Panitumumab |
|---|---|
| Started | 3091 |
| Completed | 3085 |
| Not completed | 6 |
| Withdrew: Survey form not completed | 5 |
| Withdrew: Not treated | 1 |
The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.
| Participants | Panitumumab |
|---|---|
| Frequency of adverse drug reactions | 2595 |
| MedDRA SOC: Skin and subcutaneous tissue disorders | 2364 |
| MedDRA SOC: Infections and infestations | 771 |
| MedDRA SOC: Gastrointestinal disorders | 642 |
| MedDRA SOC: Metabolism and nutrition disorders | 552 |
| MedDRA SOC: Cardiac disorders | 7 |
Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.
| Months | Panitumumab |
|---|---|
| Progression-free Survival | 3.5 (3.3 to 4.0) |
Overall survival was defined as the time to death from the start of panitumumab administration was tabulated.
| weeks | Panitumumab |
|---|---|
| Overall Survival | 41 (36 to 47) |
Collected over For up to 42 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Panitumumab | — | 614/1,254 (49%) | 640/1,254 (51%) |
| Concomitant Administration of Panitumumab and Chemotherapy | — | 747/1,831 (40.8%) | 1,084/1,831 (59.2%) |
| Event | Panitumumab | Concomitant Administration of Panitumumab and Chemotherapy |
|---|---|---|
| Colorectal cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 524/1254 | 557/1831 |
| Interstitial lung diseasesRespiratory, thoracic and mediastinal disorders | 16/1254 | 27/1831 |
| DiarrhoeaGastrointestinal disorders | 1/1254 | 26/1831 |
| StomatitisGastrointestinal disorders | 3/1254 | 24/1831 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/1254 | 17/1831 |
| Decreased appetiteMetabolism and nutrition disorders | 5/1254 | 16/1831 |
| Dermatitis acneiformSkin and subcutaneous tissue disorders | 7/1254 | 14/1831 |
| Neutrophil count decreasedInvestigations | 0/1254 | 13/1831 |
| PneumoniaInfections and infestations | 2/1254 | 12/1831 |
| Infusion related reactionInjury, poisoning and procedural complications | 0/1254 | 12/1831 |
| Event | Panitumumab | Concomitant Administration of Panitumumab and Chemotherapy |
|---|---|---|
| Dermatitis acneiformSkin and subcutaneous tissue disorders | 617/1254 | 959/1831 |
| StomatitisGastrointestinal disorders | 123/1254 | 463/1831 |
| ParonychiaInfections and infestations | 269/1254 | 458/1831 |
| Dry skinSkin and subcutaneous tissue disorders | 265/1254 | 344/1831 |
| HypomagnesaemiaMetabolism and nutrition disorders | 218/1254 | 198/1831 |
| RashSkin and subcutaneous tissue disorders | 98/1254 | 160/1831 |
| DiarrhoeaGastrointestinal disorders | 30/1254 | 155/1831 |
| AcneSkin and subcutaneous tissue disorders | 81/1254 | 112/1831 |
3086 participants completed the survey form (5 participants did not complete it). 3085 participants were included in the safety analysis set after excluding 1 participant due to missing panitumumab treatment and AE data. From that set, 3084 participants were included in the efficacy analysis set after excluding 1 participant with missing data.
| Age, Customized(Participants) | Panitumumab |
|---|---|
| < 75 years | 2582 |
| >= 75 years | 503 |
| Sex: Female, Male(Participants) | Panitumumab |
|---|---|
| Female | 1120 |
| Male | 1965 |
| Race/Ethnicity, Customized(Participants) | Panitumumab |
|---|---|
| Asian | 3085 |
| Region of Enrollment(Participants) | Panitumumab |
|---|---|
| Japan | 3085 |
| KRAS genotype(Participants) | Panitumumab |
|---|---|
| Wild type | 3003 |
| Non-measurable/non-assessable | 78 |
| Mutant | 3 |
| Not determined | 1 |
| Unknown | 0 |
| Treatment stage (excluding posteroperative adjuvant chemotherapy)(Participants) | Panitumumab |
|---|---|
| First-line | 310 |
| Second-line | 543 |
| Third-line or later | 2232 |
| Unknown | 0 |
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at baseline(Participants) | Panitumumab |
|---|---|
| PS:0 | 1877 |
| PS:1 | 942 |
| PS:2 | 241 |
| PS:3 | 22 |
| PS:4 | 3 |
| Unknown | 0 |
| Metastatic lesions/sites of relapse(Participants) | Panitumumab |
|---|---|
| No | 38 |
| Yes | 3046 |
| Unknown | 1 |
No study locations are listed for this record.
The record gives a start of Jun 2010, a primary completion of Jul 2012 and a completion of Jul 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2017, 4 years 9 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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