3
Indication details
- Control Arm
- Single arm (Phase II)
- Treatment setting
- Platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.
- Tumour Type
-
Gynaecological Malignancies
- Tumour Sub-type
- Ovarian, fallopian tubes and peritoneum cancer
- Tumour Stage
- Relapsed or progressive
- Tumour Sub-Group
- BRCA mutation
- Trial Name
- ARIEL2
- NCT Number
- NCT01482715│NCT01891344
- Trial Phase
- Phase I/II
Approval details
- FDA Approval
- FDA approval December 2018
- EMA Approval
- EMA (CHMP) March 2018 EC decision May 2018
Primary Outcome(s)
- Primary Outcome(s)
- ORR
- Evaluated Outcome
- ORR
- Form(s)
- Form 3
Outcome Data
- PFS Control
- 10.9 months
- ORR
- 80%
- DoR
- 9.7 months
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Final Score (after adjustments)
- Preliminary non-curative score
-
3
- Final non-curative score
-
3
- Comment
-
EMA (CHMP) March 2018 EC decision May 2018
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 190
- Scorecard version
- 1
- Issue date
- 17.07.2020
- Last update
- 21.04.2023
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.