A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:June 2016

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A Phase 3 Study of BBI-608 in Combination With 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC).

This is an international multi-center, prospective, open-label, randomized, adaptive design
phase 3 trial of the cancer stem cell pathway inhibitor napabucasin plus standard bi-weekly
FOLFIRI versus standard bi-weekly FOLFIRI in patients with previously treated metastatic
colorectal cancer (CRC).


Inclusion Criteria:

1. Written, signed consent for trial participation must be obtained from the patient
appropriately in accordance with applicable ICH guidelines and local and regulatory
requirements prior to the performance of any study specific procedure.

2. Must have histologically confirmed advanced CRC that is metastatic.

3. Must have failed treatment with one regimen containing a fluoropyrimidine, oxaliplatin
with or without bevacizumab for metastatic disease. All patients must have received a
minimum of 6 weeks of the first-line regimen that included bevacizumab (if
applicable), oxaliplatin and a fluoropyrimidine in the same cycle. Treatment failure
is defined as radiologic progression during or < 6 months after the last dose of
first-line therapy.

4. FOLFIRI therapy is appropriate for the patient and is recommended by the Investigator.

5. Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as
necessary to document all sites of disease performed within 21 days prior to
randomization. Patients with either measurable disease or non-measurable evaluable
disease are eligible.

6. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

7. Must be ≥ 18 years of age.

8. For male or female patient of child bearing potential: Must agree to use contraception
or take measures to avoid pregnancy during the study and for 180 days for female and
male patients, of the final FOLFIRI dose. Patients who receive single agent
napabucasin without FOLFIRI must agree to use contraception or take measures to avoid
pregnancy during the study and for 30 days for female patients and 90 days for male
patients, of the final napabucasin dose.

9. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy
test within 5 days prior to randomization. The minimum sensitivity of the pregnancy
test must be 25 IU/L or equivalent units of HCG.

10. Must have alanine transaminase (ALT) ≤ 3 × institutional upper limit of normal (ULN)
[≤ 5 × ULN in presence of liver metastases] within 14 days prior to randomization.

11. Must have hemoglobin (Hgb) ≥ 9.0 g/dL within 14 days prior to randomization. Must not
have required transfusion of red blood cells within 1 week of baseline Hgb assessment.

12. Must have total bilirubin ≤ 1.5 × institutional ULN [≤ 2.0 x ULN in presence of liver
metastases] within 14 days prior to randomization.

13. Must have creatinine ≤ 1.5 × institutional ULN or Creatinine Clearance > 50 ml/min (as
calculated by the Cockcroft-Gault equation (Chronic Kidney Disease Epidemiology
Collaboration [CKD-EPI]) within 14 days prior to randomization.

14. Must have absolute neutrophil count ≥ 1.5 x 10^9/L within 14 days prior to
randomization.

15. Must have platelet count ≥ 100 x 10^9/L within 14 days prior to randomization. Must
not have required transfusion of platelets within 1 week of baseline platelet
assessment.

16. Patient must have adequate nutritional status with Body Mass Index (BMI) > 18 kg/m^2
and body weight of > 40 kg with serum albumin > 3 g/dL.

17. Other baseline laboratory evaluations, listed in Section 6.0, must be done within 14
days prior to randomization.

18. Patient must consent to provision of, and Investigator(s) must confirm access to and
agree to submit a representative formalin fixed paraffin block of tumor tissue in
order that the specific biomarker assays may be conducted. Submission of the tissue is
to occur prior to randomization, unless approved by the Sponsor. Where local center
regulations prohibit submission of blocks of tumor tissue, two 2 mm cores of tumor
from the block and 10-30 unstained slides of whole sections of representative tumor
tissue are preferred. Where two 2 mm cores of tumor from the block are unavailable,
10-30 unstained slides of whole sections of representative tumor tissue alone are
acceptable. Where no previously resected or biopsied tumor tissue exists or is
available, on the approval of the Sponsor/designated CRO, the patient may still be
considered eligible for the study.

19. Patient must consent to provision of a sample of blood in order that the specific
correlative marker assays may be conducted.

20. Patients must be accessible for treatment and follow-up. Patients registered on this
trial must receive protocol treatment and be followed at the participating center.
This implies there must be reasonable geographical limits placed on patients being
considered for this trial. Investigators must ensure that the patients randomized on
this trial will be available for complete documentation of the treatment, response
assessment, adverse events, and follow-up.

21. Protocol treatment is to begin within 2 calendar days of patient randomization.

22. The patient is not receiving therapy in a concurrent clinical study and the patient
agrees not to participate in other interventional clinical studies during their
participation in this trial while on study treatment. Patients participating in
surveys or observational studies are eligible to participate in this study.

Exclusion Criteria:

1. Anti-cancer chemotherapy or biologic therapy if administered prior to the first
planned dose of study medication (napabucasin or FOLFIRI) within period of time
equivalent to the usual cycle length of the regimen. An exception is made for oral
fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose
must be observed prior to the first planned dose of study medication. Standard dose of
bevacizumab (5 mg/kg) may be administered prior to FOLFIRI infusion, per Investigator
decision, for as long as permanent decision to include or exclude bevacizumab is made
prior to patient randomization. Radiotherapy, immunotherapy (including immunotherapy
administered for non-malignant diseaseneoplastic treatment purposes), or
investigational agents within four weeks of first planned dose of study medication,
with the exception of a single dose of radiation up to 8 Gy (equal to 800 RAD) with
palliative intent for pain control up to 14 days before randomization.

2. More than one prior chemotherapy regimen administered in the metastatic setting.

3. Major surgery within 4 weeks prior to randomization.

4. Patients with any known brain or leptomeningeal metastases are excluded, even if
treated.

5. Women who are pregnant or breastfeeding. Women should not breastfeed while taking
study treatment and for 4 weeks after the last dose of napabucasin or while undergoing
treatment with FOLFIRI and for 180 days after the last dose of FOLFIRI.

6. Gastrointestinal disorder(s) which, in the opinion of the Qualified/Principal
Investigator, would significantly impede the absorption of an oral agent (e.g.
intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric
and small intestine resection).

7. Unable or unwilling to swallow napabucasin capsules daily.

8. Prior treatment with napabucasin.

9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, clinically significant non-healing or healing wounds, symptomatic
congestive heart failure, unstable angina pectoris, clinically significant cardiac
arrhythmia, significant pulmonary disease (shortness of breath at rest or mild
exertion), uncontrolled infection or psychiatric illness/social situations that would
limit compliance with study requirements.

10. Known hypersensitivity to 5-fluorouracil/leucovorin

11. Known dihydropyrimidine dehydrogenase (DPD) deficiency

12. Known hypersensitivity to irinotecan

13. Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis)

14. Patients receiving treatment with St. John's wort or Phenytoin.

15. Patients who plan to receive yellow fever vaccine during the course of the study
treatment.

16. Abnormal glucuronidation of bilirubin, known Gilbert's syndrome

17. Patients with QTc interval > 470 milliseconds

18. For patients to be treated with a regimen containing bevacizumab:

- History of cardiac disease: congestive heart failure (CHF) > New York Heart
Association (NYHA) Class II; active coronary artery disease, myocardial
infarction within 6 months prior to study entry; unevaluated new onset angina
within 3 months or unstable angina (angina symptoms at rest) or cardiac
arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are
permitted).

- Current uncontrolled hypertension (systolic blood pressure [BP] > 150 mmHg or
diastolic pressure > 90 mmHg despite optimal medical management) as well as prior
history of hypertensive crisis or hypertensive encephalopathy.

- History of arterial thrombotic or embolic events (within 6 months prior to study
entry)

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection,
symptomatic peripheral vascular disease)

- Evidence of bleeding diathesis or clinically significant coagulopathy

- Major surgical procedure (including open biopsy, significant traumatic injury,
etc.) within 28 days, or anticipation of the need for major surgical procedure
during the course of the study as well as minor surgical procedure (excluding
placement of a vascular access device or bone marrow biopsy) within 7 days prior
to study enrollment

- Proteinuria at screening as demonstrated by urinalysis with proteinuria ≥ 2+
(patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline
should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in
24 hours to be eligible).

- History of abdominal fistula, gastrointestinal perforation, peptic ulcer, or
intra-abdominal abscess within 6 months

- Ongoing serious, non-healing wound, ulcer, or bone fracture

- Known hypersensitivity to any component of bevacizumab

- History of reversible posterior leukoencephalopathy syndrome (RPLS)

- History of hypersensitivity to Chinese hamster ovary (CHO) cells or other human
or humanized recombinant antibodies.

19. Patients with a history of other malignancies except: adequately treated non-melanoma
skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors
curatively treated with no evidence of disease for > 3 years.

20. Any active disease condition which would render the protocol treatment dangerous or
impair the ability of the patient to receive protocol therapy.

21. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance
with the protocol.
We found this trial at
75
sites
818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Phone: 316-613-4318
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Phone: 480-342-3256
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Phone: 206-606-7350
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Albuquerque, New Mexico 87131
(505) 277-0111
Phone: 505-385-8027
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Ann Arbor, Michigan 48109
Phone: 734-763-3803
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Arlington Heights, Illinois 60005
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Atlanta, Georgia 30318
Phone: 678-298-3241
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Bankstown, New South Wales 2200
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Birmingham, Alabama 35223
Phone: 205-263-9746
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Buffalo, New York 14263
Phone: 716-845-4886
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-4271
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1441 North Beckley Avenue
Dallas, Texas 75203
Phone: 972-780-3406
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Phone: 570-271-2611
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Denton, Texas 76210
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Denver, Colorado 80218
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1500 East Duarte Road
Duarte, California 91010
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East Setauket, New York 11733
Phone: 631-675-5143
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Evanston, Illinois
Phone: 847-570-2112
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8503 Arlington Boulevard
Fairfax, Virginia 22031
Phone: 571-389-0873
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Fort Belvoir, Virginia 22060
Phone: 571-231-3491
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3840 Broadway
Fort Myers, Florida 33901
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Fort Wayne, Indiana 46805
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Goshen, Indiana 46526
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Grand Island, Nebraska 68803
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2635 North 7th Street
Grand Junction, Colorado 81501
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Hampton, Virginia 23666
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1150 North 35th Avenue
Hollywood, Florida 33021
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Houston, Texas 77090
Phone: 877-870-2640
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Phone: 816-276-4459
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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Knoxville, Tennessee 37920
Phone: 865-305-5120
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9500 Gilman Drive
La Jolla, California 92093
Phone: 858-822-5352
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1700 Tree Lane
Lawrenceville, Georgia 30046
Phone: 678-312-3834
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Lebanon, New Hampshire
Phone: 603-650-6380
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Los Angeles, California 90017
Phone: 213-977-1214
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Phone: 232-865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Memphis, Tennessee 38120
Phone: 901-683-0085
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Miami, Florida 33176
Phone: 305-595-2141
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5340 Holy Cross Parkway
Mishawaka, Indiana 46545
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Morristown, New Jersey 07962
Phone: 973-436-1755
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Phone: 615-289-9205
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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New York, New York 10021
Phone: 646-962-6200
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Newark, Delaware
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Ogden, Utah 84403
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Omaha, Nebraska 68118
Phone: 402-991-8468
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Omaha, Nebraska 68106
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111 North 175th Street
Omaha, Nebraska 68118
Phone: 423-702-7897
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Phoenix, Arizona 85054
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Pittsburgh, Pennsylvania 15240
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Plano, Texas 75093
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Roanoke, Virginia 24014
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Rochester, Minnesota 55905
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3015 North Ballas Road
Saint Louis, Missouri 63131
Phone: 314-996-5569
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1100 Charlotte Avenue
Saint Petersburg, Florida 33705
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2130 Northeast Interstate 410 Loop
San Antonio, Texas 78217
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Santa Monica, California 90404
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Seattle, Washington 98111
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Tinley Park, Illinois 60487
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4126 North Holland Sylvania Road
Toledo, Ohio 43623
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Tucson, Arizona 85704
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Tyler, Texas 75702
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Vancouver, Washington 98684
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4405 Weaver Parkway
Warrenville, Illinois 60555
Phone: 630-315-1918
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West Palm Beach, Florida 33401
Phone: 561-472-1696
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Wichita Falls, Texas 76310
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Winston-Salem, North Carolina 27157
Phone: 336-713-6912
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Worcester, Massachusetts 01605
Phone: 774-455-4456
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