3
Indication details
- Control Arm
- Single arm trials (Phase I/II)
- FDA Therapeutic Indication
- Treatment of adult and paediatric patients older than 1 month with solid tumours that have NTRK gene fusion, who have disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have not received a prior NTRK inhibitor, and who have no satisfactory treatment options.
- Tumour Type
-
Tumour agnostic
- Tumour Stage
- Locally advanced or metastatic
- Tumour Sub-Group
- NTRK gene fusion
- Trial Name
- STARTRK-1; STARTRK-2; ALKA-372-001
- NCT Number
- NCT02097810│NCT02568267 | EudraCT 2012-000148-88
- Trial Phase
- Phase I/II
Approval details
- FDA Approval
- FDA approval August 2019
- EMA Approval
- EMA (CHMP) April 2024. EC decision June 2024
Primary Outcome(s)
- Primary Outcome(s)
- ORR,DOR
- Evaluated Outcome
- ORR,DOR Overall population (integrated analysis)
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 13.8 months
- ORR
- 61.2%
- DoR
- 20.0 months
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 209
- Scorecard version
- 1
- Issue date
- 23.07.2020
- Last update
- 29.04.2024
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.