| Protocol ID | NCT01719549 |
| Registration Date | 2012-11-01 |
| Status | completed |
| Sponsor | Asan Medical Center |
| Country | South Korea |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2012-09-01 |
| Last Patient Out | 2016-11-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT01719549
A Phase II Trial of Dovitinib Monotherapy as Salvage Treatment in Patients With Metastatic or Unresectable Gastric Cancer Harboring FGFR2(Fibroblast Growth Factor Receptor 2) Amplification After Failure of First or Second Line Chemotherapy
| Field |
OPENAI
gpt-4o Thinking: o3 7185ms / 9760 tok |
CLAUDE
claude-sonnet-4-20250514 6839ms / 11442 tok |
GLM
glm-5.1 10367ms / 9940 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | Cancer | Cancer | Cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other | hospital | other | – |
| feasibility |
N/A
fully powered RCT → N/A → N/A
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: N/A — This is a single-arm, open-label phase II study, which is not a randomized controlled trial (RCT).
Thinking: N/A — Single-arm phase II study, not a randomized controlled trial.
|
feasibility RCT |
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — This is a single-arm, non-randomized interventional study (Allocation is NA) and therefore does not qualify as a randomized controlled trial (RCT).
|
– |
| intervention_pharmacologic | yes | yes | yes | OK |
| intervention_chemo_immuno_radio | yes | no | yes | – |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub |
not yet FDA/EMA approved
chemotherapy → not yet FDA/EMA approved
shaky reasoning✓ Unanimous
Initial: chemotherapy
Requery: not yet FDA/EMA approved — Dovitinib (TKI258) is an investigational drug not yet approved by FDA/EMA for this indication.
|
other |
not yet FDA/EMA approved
not yet FDA/EMA approved → not yet FDA/EMA approved
shaky reasoning✓ Unanimous
Initial: not yet FDA/EMA approved
Requery: not yet FDA/EMA approved — Dovitinib (TKI258) is an investigational, experimental tyrosine kinase inhibitor that is not currently approved by the FDA or EMA for this or any indication.
|
– |