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KRAS and NRAS Wild-type Colorectal CancerPhase 1NCT02199223

Regorafenib + Panitumumab for Colorectal Cancers

A Phase 1 study testing regorafenib + panitumumab in people with KRAS and NRAS Wild-type Colorectal Cancer, run by University of Utah at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Evaluate the safety of regorafenib and panitumumab Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
regorafenib + panitumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Jun 2014to May 2016
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Histological diagnosis of un-resectable or metastatic colorectal cancer which is KRAS and NRAS mutation negative (wild-type). Patients with any known mutation in KRAS or NRAS codons 12, 13, 59, 61, 117 or 146 will be excluded. Mutations of KRAS and NRAS codons not listed above are allowed. Biopsy of metastatic lesion is not required.
  • Patients must show signs of progression (by imaging, or tumor marker elevation) after being treated with a first line or greater treatment for their un-resectable or metastatic colorectal cancer.
  • Age 18 years or older.
  • ECOG Performance Status 0-1
  • Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
  • Acute toxic effects of all prior treatment have resolved to NCI-CTCAE v4.0 less than or equal to Grade 1 or baseline prior to beginning treatment. Alopecia (any grade) is allowed. Peripheral neuropathy less than or equal to Grade 2 is allowed.
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  • Adequate bone marrow, renal and liver function as assessed by protocol laboratory requirements
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
  • Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug. Highly effective contraception must be used (e.g. male condom with spermicidal, diaphragm with spermicidal, intra-uterine device) must be used by both sexes.
  • Subject must be able to swallow medication.
  • Measurable disease at screening by RECIST 1.1 criteria

Who cannot join

  • Any known mutation in KRAS or NRAS codons 12, 13, 59, 61, 117 or 146.
  • Prior use of regorafenib.
  • Known or suspected grade 3 allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of the trial.
  • Uncontrolled hypertension (systolic pressure greater than140 mm Hg or diastolic pressure greater than 90 mm Hg [NCI-CTCAE v4.0] on mean of 3 consecutive readings despite optimal medical management. Hypertension may be corrected by adding or adjusting anti-hypertensives prior to the initiation of treatment at the discretion of the practitioner.
  • Active or clinically significant cardiac disease including congestive heart failure, uncontrolled cardiac arrhythmias, or unstable angina.
  • Evidence or history of congenital or acquired hypocoagulability disorders.
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  • Any hemorrhage or bleeding event greater than or equal to NCI CTCAE v.4.0 Grade 3 within 4 weeks prior to start of study medication.
  • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism that have initiated within 6 months of start of study treatment. Stable, persistent events under appropriate management diagnosed greater than 6 months prior to treatment are allowed at the discretion of the investigator.
  • Subjects who are receiving treatment for a concurrent cancer that is distinct in primary site or histology from colorectal carcinoma, except any cancer in-situ, treated basal cell or squamous cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease more than 1 year before randomization are allowed. All cancer treatments must be completed at least 1 year prior to start of study treatment.
  • Patients with severe hepatic impairment (Child-Pugh Class C).
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy. Baseline testing is not required.
  • Patients requiring IV antiviral or IV antibiotic treatment for ongoing infections.
  • Symptomatic metastatic brain or meningeal tumors. Baseline brain imaging is not required.
  • Presence of a non-healing wound or bone fracture.
  • Patient's with a history of kidney disease or persistent proteinuria must have less than Grade 3 proteinuria per NCI CTCAE v4.0 at screening. If a patient has a history of kidney disease or persistent proteinuria, a urine protein test will be performed on a random urine sample. If the result is normal then no additional testing is required. If the result is abnormal, a 24 hour urine will be collected to determine if proteinuria is less than Grade 3.
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  • Any malabsorption condition that in the opinion of the investigator would significantly impact drug absorption.
  • Women who are pregnant or breast-feeding.
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
  • Substance abuse, medical, psychological or social conditions that in the opinion of the investigator may interfere with the subject's participation in the study or evaluation of the study results.
  • Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) within 3 weeks of starting study treatment.
  • Concurrent use of another investigational drug or device during, or within 3 weeks of starting study treatment.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 3 weeks before start of study medication.
  • Concurrent use of strong CYP3a4 inducers (e.g. rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort)
  • Concurrent use with strong inhibitors of CYP3A4 (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazadone, posaconazole, telithromycin, and voriconazole)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: Combination Study of Panitumumab and Regorafenib in Advanced or Metastatic KRAS and NRAS Wild Type Colorectal Cancers

Evaluate the safety of regorafenib and panitumumab

Being tested
regorafenib + panitumumab

What participants receive

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

  • regorafenib + panitumumabDrug

Study groups in NCT02199223
Study groupRoleWhat they receive
panitumumab + regorafenibExperimentalNot described
Receives: Drug: regorafenib + panitumumab

What is being measured

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

  1. Safety of regorafenib + panitumumab

    safety of combination for duration of treatment

    Measured: Safety of the drug combination will be measured by number and severity of adverse events experienced while patients are on treatment which will be about 2-3 months if not more depending on the response to treatment.

Timeline

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

  1. First posted24 Jul 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionMay 2016
  4. Study completionMay 2016

Why it stopped: Slow accrual

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02199223
Sponsor's protocol ID
HCI72561
Status last verified
Sep 2016
First submitted
30 Jun 2014
Last updated
22 Sep 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing regorafenib + panitumumab in people with KRAS and NRAS Wild-type Colorectal Cancer, run by University of Utah at 1 site in United States.

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 11 inclusion and 25 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: stopped early, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Slow accrual). Results are not available in the source record.

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?

Safety of regorafenib + panitumumab (time frame: Safety of the drug combination will be measured by number and severity of adverse events experienced while patients are on treatment which will be about 2-3 months if not more depending on the response to treatment.). 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 NCT02199223.

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 22 Sep 2016.

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