Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer (RECITE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03362177|
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : June 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Thrombocytopenia||Biological: Romiplostim Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RECITE: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy- Induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer|
|Actual Study Start Date :||September 30, 2019|
|Estimated Primary Completion Date :||August 29, 2023|
|Estimated Study Completion Date :||July 30, 2024|
The study in a 2:1 randomization ratio(108 subjects to romiplostim). Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of gastrointestinal/colorectal/pancreatic cancer.
Placebo Comparator: Placebo
The study in a 2:1 randomization ratio (54 subjects to placebo) Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.
- Incidence of a Thrombocytopenia-induced chemotherapy dose modification during the second or third on study chemotherapy cycles. [ Time Frame: 48 days ]No thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-study chemotherapy regimen. Thrombocytopenia-induced modifications include chemotherapy dose reduction, delay, omission, or chemotherapy treatment discontinuation due to platelet counts below 100 x 10 9/L
- Depth of Platelet Count [ Time Frame: 48 days ]the depth of the platelet count nadir from the start of the first on-study chemotherapy cycle through the end of the treatment period
- First platelet response [ Time Frame: 7 Days ]The time to first platelet response, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days
- Bleeding Events [ Time Frame: 48 days ]
the duration-adjusted event rate of
≥ grade 2 bleeding events, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale
- Overall Survival [ Time Frame: 1-year ]1-year overall survival
- Subject incidence of Platelet Transfusion [ Time Frame: 48 days ]platelet transfusion(s) during the treatment period
- Platelet Count [ Time Frame: 7 days ]achieving a platelet count equal to or greater than 100 x 10 9/L at any time after study day 1 to week 4 (ie, 7 days after the planned third dose of investigational product) and in the absence of platelet transfusions during the preceding 7 days
- AEs/SAEs overall safety of romiplostim [ Time Frame: 36 months ]Through end of study, up to 36 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362177
|Contact: Amgen Call Centeremail@example.com|