Who is sponsoring NCT01732783?

NCT01732783 is sponsored by Amgen.

What drugs are being tested in NCT01732783?

Interventions in NCT01732783: Panitumumab + Chemotherapy.

What condition does NCT01732783 study?

NCT01732783 studies Wild-type RAS Metastatic Colorectal Cancer.

Is NCT01732783 still recruiting?

NCT01732783 is currently completed. Last updated 8 November 2022.

Are results published for NCT01732783?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-11-08 · How we verify

NCT01732783

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

Completed Results posted Last updated 8 November 2022

What this trial tests

trial testing Panitumumab + Chemotherapy in Wild-type RAS Metastatic Colorectal Cancer in 213 participants. Completed in 30 November 2016.

Timeline

10 December 2012

Primary endpoint
30 November 2016

30 November 2016

Quick facts

Lead sponsor	Amgen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	213
Start date	10 December 2012
Primary completion	30 November 2016
Estimated completion	30 November 2016

Drugs / interventions tested

Panitumumab + Chemotherapy

Conditions studied

Wild-type RAS Metastatic Colorectal Cancer — all drugs for Wild-type RAS Metastatic Colorectal Cancer →

Sponsor

Amgen — full company profile →

Who can join

18 and older, any sex, with Wild-type RAS Metastatic Colorectal 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.

Total Number of Panitumumab Infusions Primary · 12 months

Group	Value	95% CI
Panitumumab + FOLFOX First-line	10.0	6.0 – 16.0
Panitumumab + FOLFIRI Second-line	10.0	6.0 – 16.0
Panitumumab + FOLFIRI First-line	8.0	4.0 – 15.5

Cumulative Dose of Panitumumab Primary · 12 months

Group	Value	95% CI
Panitumumab + FOLFOX First-line	4262.5	2311.5 – 6902.5
Panitumumab + FOLFIRI Second-line	4000.0	2400.0 – 6000.0
Panitumumab + FOLFIRI First-line	3782.5	1772.5 – 5751.0

Maximum Dose of Panitumumab Primary · 12 months

Group	Value	95% CI
Panitumumab + FOLFOX First-line	450.0	380.0 – 520.0
Panitumumab + FOLFIRI Second-line	420.0	390.0 – 500.0
Panitumumab + FOLFIRI First-line	507.0	424.0 – 590.0

Duration of Panitumumab Exposure Primary · 12 months

Duration of exposure is the time from the first to the last panitumumab infusion

Group	Value	95% CI
Panitumumab + FOLFOX First-line	5.339	2.546 – 10.053
Panitumumab + FOLFIRI Second-line	6.012	2.464 – 8.246
Panitumumab + FOLFIRI First-line	5.339	1.922 – 12.008

Mean Interval Between Panitumumab Infusions Primary · 12 months

Group	Value	95% CI
Panitumumab + FOLFOX First-line	0
Panitumumab + FOLFIRI Second-line	0
Panitumumab + FOLFIRI First-line	0
Panitumumab + FOLFOX First-line	38
Panitumumab + FOLFIRI Second-line	7
Panitumumab + FOLFIRI First-line	2
Panitumumab + FOLFOX First-line	98
Panitumumab + FOLFIRI Second-line	22
Panitumumab + FOLFIRI First-line	4
Panitumumab + FOLFOX First-line	21
Panitumumab + FOLFIRI Second-line	8
Panitumumab + FOLFIRI First-line	5

Percentage of Participants With at Least One Panitumumab Dose Reduction Primary · 12 months

Group	Value	95% CI
Panitumumab + FOLFOX First-line	36.6	29.6 – 44.2
Panitumumab + FOLFIRI Second-line	21.6	11.4 – 37.2
Panitumumab + FOLFIRI First-line	50.0	25.4 – 74.6

Percentage of Participants With at Least One Panitumumab Dose Delay Primary · 12 months

Group	Value	95% CI
Panitumumab + FOLFOX First-line	42.7	35.4 – 50.3
Panitumumab + FOLFIRI Second-line	21.6	11.4 – 37.2
Panitumumab + FOLFIRI First-line	41.7	19.3 – 68.0

Reasons for Discontinuation of Panitumumab Primary · 12 months

Group	Value	95% CI
Panitumumab + FOLFOX First-line	35
Panitumumab + FOLFIRI Second-line	12
Panitumumab + FOLFIRI First-line	3
Panitumumab + FOLFOX First-line	30
Panitumumab + FOLFIRI Second-line	7
Panitumumab + FOLFIRI First-line	0
Panitumumab + FOLFOX First-line	16
Panitumumab + FOLFIRI Second-line	1
Panitumumab + FOLFIRI First-line	0
Panitumumab + FOLFOX First-line	12
Panitumumab + FOLFIRI Second-line	3
Panitumumab + FOLFIRI First-line	1

Duration of Exposure of All Concomitant Chemotherapy Primary · 12 months

Duration of exposure is the time from the first date to the last date of chemotherapy administration.

Group	Value	95% CI
Panitumumab + FOLFOX First-line	5.240	2.595 – 8.969
Panitumumab + FOLFIRI Second-line	5.092	2.431 – 7.622
Panitumumab + FOLFIRI First-line	3.860	1.889 – 9.413

Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction Primary · 12 months

Group	Value	95% CI
Panitumumab + FOLFOX First-line	43.3
Panitumumab + FOLFIRI Second-line	24.3
Panitumumab + FOLFIRI First-line	58.3

Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay Primary · 12 months

Group	Value	95% CI
Panitumumab + FOLFOX First-line	29.3
Panitumumab + FOLFIRI Second-line	29.7
Panitumumab + FOLFIRI First-line	33.3

Number of Participants With at Least One Hospitalization Secondary · 12 months

Group	Value	95% CI
Panitumumab + FOLFOX First-line	163
Panitumumab + FOLFIRI Second-line	37
Panitumumab + FOLFIRI First-line	12

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of panitumumab until 30 days after last dose, or up to the 12 month end of study observation period, whichever occurred first; median reporting period was 6.3, 7.0, and 6.3 months for each group respectively.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Panitumumab + FOLFOX First-line

Serious: 10/164 (6%)

Deaths: 0/164

Panitumumab + FOLFIRI Second-line

Serious: 0/37 (0%)

Deaths: 0/37

Panitumumab + FOLFIRI First-line

Serious: 0/12 (0%)

Deaths: 0/12

Serious adverse events (14 terms)

Reaction	System	Panitumumab + FOLFOX First…	Panitumumab + FOLFIRI Seco…	Panitumumab + FOLFIRI Firs…
Diarrhoea	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Angina pectoris	Cardiac disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Asthenia	General disorders	—	—	—
Inflammation of wound	Injury, poisoning and procedural complications	—	—	—
Eastern Cooperative Oncology Group performance status worsened	Investigations	—	—	—
Dermatosis	Skin and subcutaneous tissue disorders	—	—	—
Collapse circulatory	Vascular disorders	—	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Panitumumab + FOLFOX First…	Panitumumab + FOLFIRI Seco…	Panitumumab + FOLFIRI Firs…
Rash	Skin and subcutaneous tissue disorders	—	—	—
Mucosal inflammation	General disorders	—	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—	—
Skin fissures	Skin and subcutaneous tissue disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—
Conjunctivitis	Infections and infestations	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—

Most-reported serious reactions: Diarrhoea, Vomiting, Dyspnoea, Rash, Angina pectoris, Constipation, Dyspepsia, Gastrointestinal haemorrhage.

Data from ClinicalTrials.gov NCT01732783 adverse events section.

Sponsor's own description

The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog (RAS) metastatic colorectal cancer (mCRC): as first-line treatment in combination with FOLFOX or FOLFIRI or second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Amgen trials

Trials by the same sponsor.

NCT07223190 — A Study Evaluating Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With B-cell Precursor Acute Ly · Phase 3 · not yet recruiting
NCT07493512 — Trial of Xaluritamig in Adults With Metastatic Castration-resistant Prostate Cancer · Phase 1 · not yet recruiting
NCT07531095 — Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · Phase 1 · not yet recruiting
NCT06987539 — A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Gen · Phase 2 · recruiting
NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01732783 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 8 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01732783.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing