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Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

Chemotherapy-induced Thrombocytopenia Clinical Trial

Official title:
PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

Clinical Trial Summary

To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy

Clinical Trial Description

This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer. Subjects must have a platelet count ≤ 85 x 10^9/L on day 1 of the study. The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and long-term follow-up (LTFU). Given that subjects are required to have 3 remaining planned cycles of chemotherapy, the chemotherapy cycles may be 3 or 4 weeks in duration, and the investigational product dose adjustment guidelines allow for up to 12 weeks of dosing before a subject is declared a non-responder, the majority of study subjects will receive investigational product for a range of 10-24 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03937154
Study type Interventional
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Status Recruiting
Phase Phase 3
Start date February 26, 2020
Completion date February 13, 2027
View Details
See also
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Not yet recruiting NCT03049774 - A Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor N/A
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Completed NCT00413283 - Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC) Phase 2