3
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- Grade 1 and a subset of grade 2 (Ki67 index up to 10%) GEP-NETs of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease
- Tumour Type
-
Endocrine Tumours
- Tumour Sub-type
- Neuroendocrine Tumour - Entero-pancreatic
- Tumour Stage
- Unresectable locally advanced or metastatic
- Tumour Sub-Group
- Ki67 index up t o 10%
- Trial Name
- CLARINET
- NCT Number
- NCT00353496
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval December 2014
- EMA Approval
- EMA approved
Primary Outcome(s)
- Primary Outcome(s)
- PFS (crossover allowed)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 18.0 months
- PFS Gain
- 20.3 (Calculated estimate of gain based on point estimate HR 0.47)
- PFS HR
- 0.47 (0.30-0.73)
- OS Control
- OS immature, not significant
Adjustments
- QoL Comment
-
QoL no benefit
- Toxicity Comment
-
Low toxicity
Score (after adjustments)
- Preliminary non-curative score
-
3
- Long-term plateau in the PFS curve
- PFS gain at 24 months: >10% (no plateau)
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 148
- Scorecard version
- 1
- Issue date
- 12.03.2020
- Last update
- 06.06.2023
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.