WHO ICTRP trial
To evaluate safety and efficacy of Trastuzumab, (Manufactured by Intas) in…
CTRI/2015/09/006168 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2015/09/006168 |
|---|---|
| Public title | To evaluate safety and efficacy of Trastuzumab, (Manufactured by Intas) in comparison with Reference Biologic (Trastuzumab, Marketed by Roche) in the patients with Metastatic Breast Cancer. |
| Scientific title | A prospective, multicentric, randomized, open label, parallel group, comparative, two arms, safety, efficacy and pharmacokinetic study of Trastuzumab, (Manufactured by Intas Pharmaceuticals Limited, Biopharma Division, Ahmedabad, India) in comparison with Reference Biologic (Trastuzumab, Marketed by… |
| Primary sponsor | Intas Pharmaceuticals Ltd |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: C509- Malignant neoplasm of breast of unspecified site |
| Interventions | Intervention1: Trastuzumab (Intas): Dose-8 mg/kg, 6 mg/kg, Frequency-Multiple dose, Mode of Administration-IV, Duration of treatment- 6 cycles Control Intervention1: Trastuzumab (Roche): Dose-8 mg/kg, 6 mg/kg, Frequency-Multiple dose, Mode… |
| Registration date | Aug 9, 2015 |
| Target size | 108 |
| Secondary IDs | 625-14, Version No: 01, Date: 14 Oct 2014 |
| Registry page | ctri.nic.in |
At a glance
- No Results available
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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: