Description:
Evaluate the safety of regorafenib and panitumumab
Evaluate the safety of regorafenib and panitumumab
Terminated
Phase 1
NCT ID: NCT02199223
ORG ID: HCI72561
KRAS and NRAS Wild-type Colorectal Cancer
Drug | Synonyms | Arms |
---|---|---|
regorafenib + panitumumab | panitumumab + regorafenib |
Evaluate the safety of regorafenib and panitumumab
Name | Type | Description | Interventions |
---|---|---|---|
panitumumab + regorafenib | Experimental | regorafenib + panitumumab |
Inclusion Criteria:
- Histological diagnosis of un-resectable or metastatic colorectal cancer which is KRAS
and NRAS mutation negative (wild-type) in codons 12, 13, 59, 61, 117 and 146.
Mutations of KRAS and NRAS in other codons 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.
- 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
Exclusion Criteria:
- 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.
- 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)
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Safety of regorafenib + panitumumab