Colon CancerPhase 1/2NCT00788957

Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)

A Phase 1/2 study testing Panitumumab, Ganitumab and Rilotumumab in people with Colon Cancer and Colorectal Cancer, run by NantBioScience, Inc..

Completed

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

Official record

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Trial summary

This study is a global, multicenter, open-label phase 1b and randomized, double-blinded, 2 part, phase 2 study designed to evaluate the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus panitumumab alone in patients with metastatic colorectal cancer whose tumors are wild-type KRAS… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colon Cancer, Colorectal Cancer, Gastrointestinal Cancer
What is being tested?: Panitumumab, Ganitumab and Rilotumumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 177 participants
Where: No sites listed yet
Study dates: 27 Oct 2008to 23 Jul 2010
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

metastatic adenocarcinoma of the colon or rectum
wild-type KRAS tumor status
radiographic evidence of disease progression during or following treatment with irinotecan and/or oxaliplatin containing chemotherapy for mCRC
measurable disease >/= 20 mm per Response Evaluation Criteria In Solid Tumors (RECIST)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
adequate laboratory values

Who cannot join

history of central nervous system (CNS) metastases
history of another primary cancer, unless:
curatively resected non-melanomatous skin cancer
curatively treated cervical carcinoma in situ
other primary solid tumor treated with curative intent and no known active disease present for >/= 5 years
prior treatment with an anti-epithelial growth factor receptor (EGFR), hepatocyte growth factor receptor (HGFR, c-MET), and/or insulin-like growth factor receptor (IGFR) inhibitor

Show all 19Show fewer

prior treatment with AMG 102 or AMG 479
prior treatment with chemotherapy or radiotherapy </= 21 days
prior treatment with targeted therapy </= 30 days
known allergy or hypersensitivity to panitumumab, AMG 102, or AMG 479
history of interstitial lung disease
clinically significant cardiovascular disease </= 1 year
active inflammatory bowel disease
known human immunodeficiency virus (HIV), hepatitis C, or hepatitis B infection
any co-morbid disease or condition that could increase the risk of toxicity
serious or non-healing wound </= 35 days
any uncontrolled concurrent illness or history of any medical condition that could interfere with the interpretation of the study results
major surgical procedure </= 35 days or minor surgical procedure </= 14 days
other investigational procedures or drugs </= 30 days

About this study

Official title: A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination With Panitumumab Versus Panitumumab Alone in Subject With Wild-Type KRAS Metastatic Colorectal Cancer

Read the detailed description

This study consisted of 3 parts:

Part 1: determination of the tolerable dose of rilotumumab in combination with panitumumab to be administered in Part 2.

Part 2: Comparison of the safety and efficacy of rilotumumab or ganitumab in combination with panitumumab versus that of panitumumab alone. In Part 2, participants were randomized 1:1:1 into 3 cohorts: 6 mg/kg panitumumab plus 10 mg/kg rilotumumab, 6 mg/kg panitumumab plus 12 mg/kg ganitumab, or 6 mg/kg panitumumab and placebo (panitumumab alone cohort). Panitumumab was administered open-label, and rilotumumab and ganitumab were double-blinded.

Part 3: Exploratory evaluation of the safety and efficacy of the rilotumumab and ganitumab monotherapy following treatment with panitumumab in Part 2. In Part 3, eligible participants who terminated panitumumab treatment in the Panitumumab Alone arm of Part 2 due to disease progression or intolerability could be randomized 1:1 into 2 double-blind cohorts: 10 mg/kg rilotumumab or 12 mg/kg ganitumab.

Participants who permanently discontinued all the investigational products completed a safety follow-up visit 30 days and a follow-up visit 60 days after the last dose of investigational product. Participants were followed for radiographic disease progression and survival every 3 months after the 30-day safety follow-up visit for up to 2 years after the last participant was enrolled in Part 2.

Conditions: Colon Cancer, Colorectal Cancer, Gastrointestinal Cancer, Metastatic Colorectal Cancer, Rectal Cancer
Being tested: Panitumumab, Ganitumab, Rilotumumab, Placebo
Keywords: panitumumab, vectibix, AMG 102, AMG 479, colon cancer, rectal cancer, colorectal cancer, metastatic colorectal cancer, EGFR inhibitor, IGF inhibitor, c-MET inhibitor
Medical subject headings: Colonic Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms, Rectal Neoplasms

What participants receive

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

PanitumumabDrug
Also called Vectibix®
Panitumumab for intravenous infusion
GanitumabDrug
Also called AMG 479
Ganitumab for intravenous infusion
RilotumumabDrug
Also called AMG 102
Rilotumumab for intravenous infusion
PlaceboDrug
Placebo intravenous infusion

Study groups in NCT00788957
Study group	Role	What they receive
Part 1: Panitumumab + Rilotumumab	Experimental	Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision. Receives: Drug: Panitumumab; Drug: Rilotumumab
Part 2: Panitumumab Alone	Active comparator	Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision. Receives: Drug: Panitumumab
Part 2: Panitumumab + Rilotumumab	Experimental	Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision. Receives: Drug: Panitumumab; Drug: Rilotumumab; Drug: Placebo
Part 2: Panitumumab + Ganitumab	Experimental	Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision. Receives: Drug: Panitumumab; Drug: Ganitumab; Drug: Placebo
Part 3: Rilotumumab	Experimental	Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision. Receives: Drug: Rilotumumab; Drug: Placebo
Part 3: Ganitumab	Experimental	Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision. Receives: Drug: Ganitumab; Drug: Placebo

What is being measured

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

Part 1: Number of Participants With Dose-limiting Toxicities (DLT)
A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator
Measured: 7 weeks
Part 2: Percentage of Participants With an Objective Response
An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.
Measured: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.

Secondary outcomes (19)

Duration of Response - Part 2
Time from the confirmed objective response to disease progression per the modified RECIST v1.0 criteria.
Measured: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Time to Response - Part 2
Time from the first dose of investigational product to the date of first confirmed objective response. Calculated only for subject with a confirmed objective response
Measured: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Disease Control Rate - Part 2
The incidence of confirmed objective response or stable disease. Stable disease cannot be established prior to study day 49 (calculated from the date of first dose of investigational product), ie, the earliest protocol scheduled tumor assessment
Measured: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Progression-free Survival (PFS) - Part 2
Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death
Measured: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
On-treatment Progression-free Survival (PFS) - Part 2
Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death during the treatment period (from the first to last dose of investigational product). Radiographic progression within 28 days since last dose of study therapy (last component of combination therapy) up to the initiation of another anti-tumor therapy, including the Part 3 treatment, if applicable, or death within 28 days since last dose of study therapy.
Measured: From the date of first dose until the data cut-off date of 23 July 2010. Up to 56 weeks.
Overall Survival - Part 2
The interval in months from the first dose of investigational product to the date of death.
Measured: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Cmin, Cmax of Panitumumab
Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval
Measured: 14 days
Cmin, Cmax, for Rilotumumab
Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval
Measured: 14 days
Cmin for Panitumumab - Part 2
Cmin = minimum drug concentration during a dosing interval
Measured: Up to 23 weeks
Cmax for Panitumumab - Part 2
Cmax = maximum observed drug concentration during a dosing interval
Measured: Up to 23 weeks
Cmin for Rilotumumab - Part 2
Cmin = minimum drug concentration during a dosing interval
Measured: Up to 23 weeks
Cmax for Rilotumumab - Part 2
Cmax = maximum observed drug concentration during a dosing interval
Measured: Up to 23 weeks
Cmin for Ganitumab - Part 2
Cmin = minimum drug concentration during a dosing interval
Measured: Up to 23 weeks
Cmax for Ganitumab - Part 2
Cmax = maximum observed drug concentration during a dosing interval
Measured: Up to 23 weeks
Total Anti-Panitumumab Antibody Incidence - Part 2
Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by either Biacore or ELISA.
Measured: First dose of any study drug and before 120 days of last dose of study drugs; up to 1 year, eight months
Total Anti-AMG 102 Antibody Incidence - Part 2
Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.
Measured: First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.
Total Anti-AMG 479 Antibody Incidence - Part 2
Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.
Measured: First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.
AUC for Rilotumumab
AUC = area under the drug concentration-time curve during a dosing interval
Measured: 14 Days
AUC for Panitumumab
AUC = area under the drug concentration-time curve during a dosing interval
Measured: 14 Days

Timeline

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

27 Oct 200823 Jul 2010

First posted11 Nov 2008 (estimated)
Study start27 Oct 2008
Primary completion23 Jul 2010
Study completion23 Jul 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.
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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00788957
Sponsor's protocol ID: 20060447
Status last verified: Jul 2024
First submitted: 23 Oct 2008
Last updated: 7 Aug 2024
Results posted: Yes, on ClinicalTrials.gov

Publications

Van Cutsem E, Eng C, Nowara E, Swieboda-Sadlej A, Tebbutt NC, Mitchell E, Davidenko I, Stephenson J, Elez E, Prenen H, Deng H, Tang R, McCaffery I, Oliner KS, Chen L, Gansert J, Loh E, Smethurst D, Tabernero J. Randomized phase Ib/II trial of rilotumumab or ganitumab with panitumumab versus panitumumab alone in patients with wild-type KRAS metastatic colorectal cancer. Clin Cancer Res. 2014 Aug 15;20(16):4240-50. doi: 10.1158/1078-0432.CCR-13-2752. Epub 2014 Jun 11.
PubMed 24919569
Peeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3.
PubMed 26049686

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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Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination With Panitumumab Versus Panitumumab Alone in Subject With Wild-Type KRAS Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT00788957
Acronym / sponsor ID: 20060447
Conditions: Colon Cancer, Colorectal Cancer, Gastrointestinal Cancer, Metastatic Colorectal Cancer, Rectal Cancer
Keywords: panitumumab, vectibix, AMG 102, AMG 479, colon cancer, rectal cancer, colorectal cancer, metastatic colorectal cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 177 participants (actual)
Lead sponsor: NantBioScience, Inc.Industry (pharma, biotech, devices)
Study start: 27 Oct 2008 (actual)
Primary completion: 23 Jul 2010 (actual)
Study completion: 23 Jul 2010 (actual)
First posted: 11 Nov 2008 (estimated)
Results: Posted 20 Jul 2015

Clinical summary

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

Detailed description

This study consisted of 3 parts:

Part 1: determination of the tolerable dose of rilotumumab in combination with panitumumab to be administered in Part 2.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Part 1: Panitumumab + Rilotumumab	Experimental	Drug: Panitumumab, Drug: RilotumumabParticipants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Part 2: Panitumumab Alone	Active comparator	Drug: PanitumumabParticipants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Part 2: Panitumumab + Rilotumumab	Experimental	Drug: Panitumumab, Drug: Rilotumumab, Drug: PlaceboParticipants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Part 2: Panitumumab + Ganitumab	Experimental	Drug: Panitumumab, Drug: Ganitumab, Drug: PlaceboParticipants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Part 3: Rilotumumab	Experimental	Drug: Rilotumumab, Drug: PlaceboParticipants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
Part 3: Ganitumab	Experimental	Drug: Ganitumab, Drug: PlaceboParticipants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.

Who may qualify

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

Key inclusion criteria (6 listed)

metastatic adenocarcinoma of the colon or rectum
wild-type KRAS tumor status
radiographic evidence of disease progression during or following treatment with irinotecan and/or oxaliplatin containing chemotherapy for mCRC
measurable disease >/= 20 mm per Response Evaluation Criteria In Solid Tumors (RECIST)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key exclusion criteria (19 listed)

history of central nervous system (CNS) metastases
history of another primary cancer, unless:
curatively resected non-melanomatous skin cancer
curatively treated cervical carcinoma in situ
other primary solid tumor treated with curative intent and no known active disease present for >/= 5 years

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: Vectibix®Panitumumab for intravenous infusion	Drug	Part 1: Panitumumab + Rilotumumab, Part 2: Panitumumab + Ganitumab, Part 2: Panitumumab + Rilotumumab, Part 2: Panitumumab Alone
GanitumabAlso: AMG 479Ganitumab for intravenous infusion	Drug	Part 2: Panitumumab + Ganitumab, Part 3: Ganitumab
RilotumumabAlso: AMG 102Rilotumumab for intravenous infusion	Drug	Part 1: Panitumumab + Rilotumumab, Part 2: Panitumumab + Rilotumumab, Part 3: Rilotumumab
PlaceboPlacebo intravenous infusion	Drug	Part 2: Panitumumab + Ganitumab, Part 2: Panitumumab + Rilotumumab, Part 3: Ganitumab, Part 3: Rilotumumab

Primary outcome

Part 1: Number of Participants With Dose-limiting Toxicities (DLT)
Time frame: 7 weeks
A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator
Part 2: Percentage of Participants With an Objective Response
Time frame: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.

19 secondary outcomes

Duration of Response - Part 2
Time frame: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Time to Response - Part 2
Time frame: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Disease Control Rate - Part 2
Time frame: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Progression-free Survival (PFS) - Part 2
Time frame: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
On-treatment Progression-free Survival (PFS) - Part 2
Time frame: From the date of first dose until the data cut-off date of 23 July 2010. Up to 56 weeks.
Overall Survival - Part 2
Time frame: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.
Cmin, Cmax of Panitumumab
Time frame: 14 days
Cmin, Cmax, for Rilotumumab
Time frame: 14 days
Cmin for Panitumumab - Part 2
Time frame: Up to 23 weeks
Cmax for Panitumumab - Part 2
Time frame: Up to 23 weeks
Cmin for Rilotumumab - Part 2
Time frame: Up to 23 weeks
Cmax for Rilotumumab - Part 2
Time frame: Up to 23 weeks
Cmin for Ganitumab - Part 2
Time frame: Up to 23 weeks
Cmax for Ganitumab - Part 2
Time frame: Up to 23 weeks
Total Anti-Panitumumab Antibody Incidence - Part 2
Time frame: First dose of any study drug and before 120 days of last dose of study drugs; up to 1 year, eight months
Total Anti-AMG 102 Antibody Incidence - Part 2
Time frame: First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.
Total Anti-AMG 479 Antibody Incidence - Part 2
Time frame: First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.
AUC for Rilotumumab
Time frame: 14 Days
AUC for Panitumumab
Time frame: 14 Days

Results and safety

Results posted to the registry on 20 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Panitumumab + Rilotumumab	11	2
Part 2: Panitumumab Alone	0	0
Part 2: Panitumumab + Rilotumumab	0	0
Part 2: Panitumumab + Ganitumab	0	0
Part 3: Rilotumumab	0	0
Part 3: Ganitumab	0	0

Primary outcome: Part 1: Number of Participants With Dose-limiting Toxicities (DLT)

Time frame: 7 weeks. Number. Unit: participants

Measure	Part 1: Panitumumab + Rilotumumab n = 6
Value	0

Population analysed: The first 6 DLT evaluable participants, including participants who received at least 2 doses of panitumumab and rilotumumab as scheduled (ie, Week 1 and 3) and have a minimum 28 days follow-up for safety or, have received at least 1 dose of panitumumab and rilotumumab and had a DLT within the first 28 days on study.

Primary outcome: Part 2: Percentage of Participants With an Objective Response

Time frame: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Part 2: Panitumumab Alone n = 48	Part 2: Panitumumab + Rilotumumab n = 48	Part 2: Panitumumab + Ganitumab n = 46
Value	21 (10.5 to 35.0)	31 (18.7 to 46.3)	22 (10.9 to 36.4)

Population analysed: Efficacy analysis set (enrolled participants who received at least one dose of respective investigational product in the corresponding parts of the study) with measurable baseline disease.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Panitumumab + Rilotumumab	5 of 11 (45.5%)	11 of 11 (100%)	8 of 11
Part 2: Panitumumab Alone	11 of 48 (22.9%)	42 of 48 (87.5%)	32 of 48
Part 2: Panitumumab + Rilotumumab	9 of 48 (18.8%)	47 of 48 (97.9%)	35 of 48
Part 2: Panitumumab + Ganitumab	9 of 46 (19.6%)	44 of 46 (95.7%)	37 of 46
Part 3: Rilotumumab	6 of 13 (46.2%)	11 of 13 (84.6%)	8 of 13
Part 3: Ganitumab	2 of 11 (18.2%)	9 of 11 (81.8%)	8 of 11

Limitations and caveats (from the sponsor): Part 3 of the study did not reach the accrual goal. Only 24 out of the 42 planned subjects received treatment in Part 3 of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24919569Van Cutsem E, Eng C, Nowara E, Swieboda-Sadlej A, Tebbutt NC, Mitchell E, Davidenko I, Stephenson J, Elez E, Prenen H, Deng H, Tang R, McCaffery I, Oliner KS, Chen L, Gansert J, Loh E, Smethurst D, Tabernero J. Randomized phase Ib/II trial of rilotumumab or ganitumab with panitumumab versus panitumumab alone in patients with wild-type KRAS metastatic colorectal cancer. Clin Cancer Res. 2014 Aug 15;20(16):4240-50. doi: 10.1158/1078-0432.CCR-13-2752. Epub 2014 Jun 11.
Derived from this study: PubMed 26049686Peeters M, Kafatos G, Taylor A, Gastanaga VM, Oliner KS, Hechmati G, Terwey JH, van Krieken JH. Prevalence of RAS mutations and individual variation patterns among patients with metastatic colorectal cancer: A pooled analysis of randomised controlled trials. Eur J Cancer. 2015 Sep;51(13):1704-13. doi: 10.1016/j.ejca.2015.05.017. Epub 2015 Jun 3.
Related InfoLink 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 1/2 study testing Panitumumab, Ganitumab and Rilotumumab in people with Colon Cancer and Colorectal Cancer, run by NantBioScience, Inc..

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 6 inclusion and 19 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 7 Aug 2024. 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 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 20 Jul 2015). 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: Number of Participants With Dose-limiting Toxicities (DLT) (time frame: 7 weeks). 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?

On the ClinicalTrials.gov record for NCT00788957, 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 7 Aug 2024.