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A Phase III Randomized Study of BBI608 and Best Supportive Care Versus Placebo and Best Supportive Care in Patients With Pretreated Advanced Colorectal Carcinoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Carcinoma

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Trial Information

A Phase III Randomized Study of BBI608 and Best Supportive Care Versus Placebo and Best Supportive Care in Patients With Pretreated Advanced Colorectal Carcinoma


This research is being done because currently there are no approved remaining effective
treatments for colon or rectal cancer.

The purpose of this study is to compare the effects on colon cancer of a new drug, BBI608,
and best supportive care (BSC) compared to BSC alone.

BBI608 has been shown to shrink tumours in animals and has been studied in a few people and
seems promising, but it is not clear if it can offer better results than the usual care
which is best supportive care alone.

The standard or usual treatment for this disease is treatment with drugs and other
treatments that may help to make a patient feel better or may improve their quality of life.
This treatment is known as "best supportive care" (BSC). Although patients with best
supportive care can feel better for some months, the cancer usually continues to grow.


Inclusion Criteria:



- Histologically confirmed advanced colorectal cancer that is unresectable.

- Received a prior thymidylate synthase inhibitor (e.g. 5-fluorouracil (5-FU),
capecitabine, raltitrexed, UFT) for metastatic disease or as adjuvant therapy.

- Received and failed an irinotecan containing regimen (i.e. single-agent or in
combination) for treatment of metastatic disease, OR relapsed within 6 months of
completion of an irinotecan-containing adjuvant therapy, OR have documented
unsuitability for an irinotecan-containing regimen.

- Received and failed an oxaliplatin-containing regimen for treatment of metastatic
disease, OR relapsed within 6 months of completion of an oxaliplatin-containing
adjuvant therapy OR have documented unsuitability for an oxaliplatin-containing
regimen.

- For patients with colorectal cancer that is K-ras wild type: Received and failed a
cetuximab or panitumumab-containing regimen (i.e. single-agent or in combination) for
treatment of metastatic disease OR have documented unsuitability for a cetuximab or
panitumumab-containing regimen

- The only remaining standard available therapy as recommended by the Investigator is
best supportive care.

- Must have presence of measurable disease as defined by Response Evaluation Criteria
in Solid Tumours (RECIST 1.1).

- Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as
necessary to document all sites of disease done within 14 days prior to
randomization.

- Must have an ECOG Performance Status of 0 or 1.

- Must be ≥ 18 years of age.

- For male or female patient of child producing potential: Must agree to use
contraception or take measures to avoid pregnancy during the study and for 30 days
after the last Protocol treatment dose.

- Women of child bearing potential (WOCBP) must have a negative serum or urine
pregnancy test within 72 hours prior to randomization.

- 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.

- Must have hemoglobin (Hgb) ≥ 80 g/L within 14 days prior to randomization.

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

- Must have creatinine ≤ 1.5 × institutional ULN or Creatinine Clearance > 50 ml/min
within 14 days prior to randomization.

- Must have absolute neutrophil count ≥ 1.5 x 109/L within 14 days prior to
randomization.

- Must have platelet count ≥ 75 x 109/L within 14 days prior to randomization.

- Other biochemistry which must be done within 14 days prior to randomization includes
lactate dehydrogenase (LDH) and alkaline phosphatase.

- Patient must consent to provision of, and investigator(s) must confirm access to and
agree to submit at the request of the NCIC CTG Central Tumour Bank, a representative
formalin fixed paraffin block of tumour tissue in order that the specific correlative
marker assays may be conducted.

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

- Patient is able (i.e. sufficiently fluent) and willing to complete the Quality of
Life and Health Utilities questionnaires in one of the validated languages for the
questionnaires.

- Patients must be accessible for treatment and follow-up. Patients registered on this
trial must be treated and followed at the participating centre. This implies there
must be reasonable geographical limits placed on patients being considered for this
trial.

- Protocol treatment is to begin within 2 working days of patient randomization.

- The patient is not receiving therapy in a concurrent clinical study and the patient
agrees not to participate in other clinical studies during their participation in
this trial while on study treatment.

Exclusion Criteria:

- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
within four weeks of first dose with the exception of a single dose of radiation up
to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days
before randomization.

- Major surgery within 4 weeks prior to randomization.

- Any known symptomatic brain metastases requiring steroids.

- Women who are pregnant or breastfeeding.

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

- Unable or unwilling to swallow BBI608/placebo capsules daily.

- 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.

- 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 tumours
curatively treated with no evidence of disease for ≥ 5 years.

- Prior treatment with BBI608.

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

- Any condition (e.g. psychological, geographical, etc.) that does not permit
compliance with the protocol.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

The primary objective of this study is to assess the effect of orally administered BBI608 plus best supportive care (BSC), in comparison to placebo plus best supportive care on the Overall Survival of patients with advanced histopathologically confirmed colorectal carcinoma who have exhausted all standard treatment options

Outcome Time Frame:

38 month

Safety Issue:

No

Principal Investigator

Derek Jonker

Investigator Role:

Study Chair

Investigator Affiliation:

Ottawa Health Research Institute - General Division

Authority:

Canada: Health Canada

Study ID:

CO23

NCT ID:

NCT01830621

Start Date:

April 2013

Completion Date:

December 2015

Related Keywords:

  • Colorectal Carcinoma
  • Carcinoma
  • Colorectal Neoplasms

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