Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03937154

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
  Status Clinical Trial Phase
Not yet recruiting NCT05969158 - Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma Phase 2
Active, not recruiting NCT03362177 - Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer Phase 3
Recruiting NCT05554913 - Evaluating the Efficacy and Safety of QL0911 in the Prevention of Chemotherapy- Induced Thrombocytopenia Phase 2/Phase 3
Completed NCT05688306 - To Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Thrombocytopenia Treatment
Completed NCT00283439 - A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma Phase 1/Phase 2
Not yet recruiting NCT06099925 - The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies Phase 2
Completed NCT03471078 - Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers Phase 3
Active, not recruiting NCT03976882 - Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy. Phase 3
Recruiting NCT05772546 - Avatrombopag vs. Placebo for CIT in GI Malignancies Phase 2
Not yet recruiting NCT05864014 - Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors. Phase 3
Terminated NCT01345214 - A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia Phase 1
Completed NCT01663441 - A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 Phase 3
Recruiting NCT05236582 - Herombopag for Chemotherapy-induced Thrombocytopenia Phase 2
Not yet recruiting NCT05944211 - Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia Phase 2
Withdrawn NCT03343847 - Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma. Phase 3
Completed NCT05851027 - Evaluating the Efficacy and Safety of QL0911 in Chemotherapy- Induced Thrombocytopenia Phase 2/Phase 3
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
Recruiting NCT05218226 - Avatrombopag for Chemotherapy-induced Thrombocytopenia Phase 2
Recruiting NCT04600960 - Eltrombopag for Chemotherapy-induced Thrombocytopenia Phase 2
Completed NCT00413283 - Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC) Phase 2