Dataset 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

ABSTRACT: Interventions: Group 1: Best supportive care plus BBI608. Best supportive care defined as those measures designed to provide palliation of symptoms and improve quality of life as much as possible. BBI608 will be self-administered by participants at 480mg (6 x 80mg tablets) orally twice daily (960mg total daily dose) in 28 day cycles. Patients may continue to receive protocol therapy as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and are, in the opinion of the investigator, continuing to derive benefit from protocol therapy. Patients will be asked to keep a diary of when they take the capsules and if they miss any doses to monitor adherance. Patients will also be asked to return any tablets which were not taken. Primary outcome(s): Overall survival (death from any cause)[Patient status updates will be sought every 2-4 weeks at clinic visit whilst on treatment and then every 8 weeks until death.] Study Design: Purpose: Treatment; Allocation: Randomised controlled trial

DISEASE(S): Advanced (metastatic Or Locally Advanced) Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2459551 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:ObjectivesSpasticity is an incurable chronic condition, and patients with spasticity frequently experience symptoms such as muscle stiffness, restricted mobility, fatigue, spasms, and pain. The study objective was to assess the cost-effectiveness of abobotulinumtoxinA plus best supportive care compared with best supportive care alone for the early treatment of adult lower limb spasticity following an acute event (e.g. stroke or traumatic brain injury), from an Australian payer perspective.MethodsUsing clinical data from published pivotal trials, an economic model based on a Markov model was developed to capture changes in treatment costs, healthcare resource use costs, functional outcomes, and health-related quality of life over a lifetime horizon. Scenario analyses and a probabilistic sensitivity analysis were conducted to explore the uncertainty in the model parameters and assumptions used in the base case.ResultsAbobotulinumtoxinA plus best supportive care was cost-effective versus best supportive care, yielding an incremental cost-effectiveness ratio of $35,721 per quality-adjusted life year gained. Sensitivity analyses confirm the robustness of the base case, with most results remaining below the commonly acceptable cost-effectiveness willingness-to-pay threshold of $75,000 per quality-adjusted life year for cost-effectiveness in Australia. Inputs and assumptions that produced the top four highest incremental cost-effectiveness ratios include the application of different health resource utilisation source, short time horizon, unweighted regression analyses to determine regression probabilities, and no stopping rule. AbobotulinumtoxinA plus best supportive care has a 74% probability of being cost-effective compared with best supportive care alone at the willingness to pay threshold.ConclusionAbobotulinumtoxinA plus best supportive care treatment is cost-effective in Australia for the management of adult lower limb spasticity in patients treated within 2 years of an acute event.

Dataset 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

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