Study of Romiplostim for Chemo-induced Thrombocytopenia in Adults Subjects With Gastrointestinal or Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03362177|
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : April 11, 2018
|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:||A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving FOLFOX-based Chemotherapy for Treatment of Gastrointestinal or Colorectal Cancer|
|Estimated Study Start Date :||September 7, 2018|
|Estimated Primary Completion Date :||August 25, 2021|
|Estimated Study Completion Date :||August 25, 2021|
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 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.
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 cancer.Other: Placebo
- Incidence of either a chemotherapy dose delay or reduction [ Time Frame: 48 days ]
A thrombocytopenia-induced modification of any myelosuppressive treatment agent in the second and third cycles of the planned on-study chemotherapy regimen. Dose modifications are defined as a dose delay by ≥ 4 days or dose reduction by
≥ 15%, or discontinuation of the agent
- First platelet recovery [ Time Frame: 7 Days ]Secondary endpoint is the time to first platelet recovery, defined by platelet count ≥ 100 x 109/L in the absence of platelet transfusions during the preceding 7 days
- Platelet Count [ Time Frame: 7 days ]7 days after 3rd dose of IP with no transfusions in preceding 7 days
- 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
- Subject incidence of Platelet Transfusion [ Time Frame: 48 days ]platelet transfusion(s) during the treatment period
- 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) grading scale during the treatment period
- AEs/SAEs [ Time Frame: 36 months ]Through end of study, up to 36 months
- Overall Survival [ Time Frame: 1-year ]1-year overall survival
- Change in Patient Global Assessment -CIT (PGA-CIT) [ Time Frame: 28 days ]
Change in Patient Global Assessment-CIT (PGA-CIT) scores on Day 1, 8 and 15 within 2 consecutive cycles.
A 4-item instrument designed to assess global change in quality of life and symptoms over time (since the previous clinic visit).
b. The amount of change is rated using a 7-point Likert-style scale ranging from 1 (very much worse) to 7 (very much better). Items are scored as single items with higher scores indicating a greater degree of improvement.
- Change in Functional Assessment of Cancer Therapy for Patients with Thrombocytopenia (FACT-Th18) [ Time Frame: 28 days ]
Change in FACT-TH18 scores on Day 1, 8 and 15 of 2 consecutive cycles.
The FACT-Th18 is a 45-item instrument that includes 28 FACT general items covering 4 domains (physical well-being, social/family well-being, emotional well-being, and functional well-being) with an additional 17 items covering Additional Concerns, 15 of which specific to thrombocytopenia. b. Scale scores range from 0 (Not at all) to 4 (Very Much) and can be derived for each of the 4 FACT--G domains, a FACT-G total score, a thrombocytopenia subscale score, and a FACT-Th total score. The FACT-Th has been evaluated as a reliable and valid measure for assessing the impact of thrombocytopenia on patients' lives that can distinguish cancer patients with and without thrombocytopenia and is responsive to increase in platelet count over time.
- Change in European Quality of Life 5 Dimension (EQ-5D) [ Time Frame: 28 days ]
Change in European Quality of Life-5 Dimensions (EQ-5D) scores on Day 1, 8 and 15 of 2 consecutive cycles.
The EQ-5D provides a simple descriptive health profile and a single index value for health status. The EQ-5D descriptive health profile comprises 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension comprises 3 levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D-3L health state is defined by combining one level from each of the 5 dimensions.
EQ-5D Index values range from -0.59 to 1.00. In addition, the EQ-5D includes a single item visual analogue scale item that records the subject's self-rated health status on a vertical graduated (0 to 100) line. Higher EQ-5D index and visual analogue scale scores represent better health status.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362177
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