WHO ICTRP trial
Multicenter, randomized, open label study evaluating a poly(ADP-ribose)…
EUCTR2009-016091-80-FR · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2009-016091-80-FR |
|---|---|
| Public title | Multicenter, randomized, open label study evaluating a poly(ADP-ribose) polymerase-1(PARP-1) inhibitor, SAR240550 (BSI-201), administered twice weekly or weekly, in combination with gemcitabine/carboplatin, in patients with metastatic Triple Negative Breast Cancer (mTNBC) |
| Scientific title | Multicenter, randomized, open label study evaluating a poly(ADP-ribose) polymerase-1(PARP-1) inhibitor, SAR240550 (BSI-201), administered twice weekly or weekly, in combination with gemcitabine/carboplatin, in patients with metastatic Triple Negative Breast Cancer (mTNBC) |
| Primary sponsor | sanofi-aventis recherche & développement |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | France;Spain;Belgium;Netherlands;Italy |
| Conditions | Metastatic Triple Negative Breast Cancer. MedDRA version: 12.0 Level: PT Classification code 10055113 Term: Breast cancer metastatic |
| Interventions | Product Code: SAR240550 (BSI-201) Pharmaceutical Form: Solution for infusion Current Sponsor code: SAR240550 (BSI-201) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Product Name… |
| Registration date | Dec 11, 2009 |
| Target size | 80 |
| Secondary IDs | TCD11418 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: