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BBI608 and Best Supportive Care vs Placebo and Best Supportive Care in Pretreated Advanced Colorectal Carcinoma
Phase 3 trial testing BBI608 in Colorectal Carcinoma in 282 participants. Completed in 16 May 2016.
| Lead sponsor | NCIC Clinical Trials Group |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 282 |
| Start date | 10 May 2013 |
| Primary completion | 7 May 2016 |
| Estimated completion | 16 May 2016 |
| Sites | 63 locations across Canada, Japan, Australia |
NCIC Clinical Trials Group
18 and older, any sex, with Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time from the day of randomization to death. For alive patients, overall survival was censored at the last day the patient was known alive (LKA).
| Group | Value | 95% CI |
|---|---|---|
| BBI608 | 4.44 | 3.68 – 4.90 |
| Placebo | 4.76 | 4.01 – 5.32 |
Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
| Group | Value | 95% CI |
|---|---|---|
| BBI608 | 1.82 | 1.74 – 1.87 |
| Placebo | 1.82 | 1.74 – 1.84 |
Proportion of all randomized patients with a documented complete response (CR) defined as disappearance of all target lesions, partial response (PR) defined as \>=30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) defined as \<30% decrease but also \<20% increase in the sum of the longest diameter of target lesions without new lesions per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 for target lesion.
| Group | Value | 95% CI |
|---|---|---|
| BBI608 | 17 | |
| Placebo | 18 |
Number of patients with at least one adverse event as assessed by NCI CTCAE Version 3.0 criteria.
| Group | Value | 95% CI |
|---|---|---|
| BBI608 | 135 | |
| Placebo | 139 |
Change scores from baseline at time 2 (8 weeks) from baseline for the global health status/quality of life scale scores (between 0 and 100 with higher value indicating better quality of life) as derived from responses of patients to the EORTC (European Organisation for Research and Treatment of Cancer) quality of life questionnaire (QLQ-C30).
| Group | Value | 95% CI |
|---|---|---|
| BBI608 | -10.61 | ± 23.1 |
| Placebo | -10.66 | ± 17.07 |
Time frame: 36 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | BBI608 | Placebo |
|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Bloating | Gastrointestinal disorders | — | — |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | — | — |
| Biliary tract infection | Infections and infestations | — | — |
| Jejunal obstruction | Gastrointestinal disorders | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Edema limbs | General disorders | — | — |
| Fatigue | General disorders | — | — |
| Malaise | General disorders | — | — |
| Other infections and infestations | Infections and infestations | — | — |
| Skin infection | Infections and infestations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Chest pain - cardiac | Cardiac disorders | — | — |
| Sinus tachycardia | Cardiac disorders | — | — |
| Supraventricular tachycardia | Cardiac disorders | — | — |
| Reaction | System | BBI608 | Placebo |
|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Urine discoloration | Renal and urinary disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Edema limbs | General disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| Pain | General disorders | — | — |
| Weight loss | Investigations | — | — |
| Headache | Nervous system disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Fever | General disorders | — | — |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Other gastrointestinal disorders | Gastrointestinal disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Bloating | Gastrointestinal disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Other skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | — | — |
| Rash acneiform | Skin and subcutaneous tissue disorders | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Dehydration, Diarrhea, Abdominal pain, Bloating, Upper gastrointestinal hemorrhage, Biliary tract infection, Jejunal obstruction, Pancreatitis.
Data from ClinicalTrials.gov NCT01830621 adverse events section.
The purpose of this study is to find out whether it is better to receive a new drug, BBI608, or better to receive no further treatment for colon or rectal cancer. To do this, half of the patients in this study will get BBI608 and the other half will receive a placebo (a substance that is designed not to do anything).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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