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Study of Romiplostim for Chemo-induced Thrombocytopenia in Adults With Lung, Ovarian, Gastrointestinal/Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03362177
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the efficacy of romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of lung, ovarian, or gastrointestinal/colorectal cancer, measured by the ability to administer ontime, full-dose hemotherapy.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Thrombocytopenia Biological: Romiplostim Other: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Lung, Ovarian, or Gastrointestinal/Colorectal Cancer.
Anticipated Study Start Date : January 28, 2019
Estimated Primary Completion Date : June 17, 2022
Estimated Study Completion Date : July 17, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Romiplostim
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Romiplostim
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.
Biological: Romiplostim
This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of lung, ovarian, or 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.
Biological: Romiplostim
This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of lung, ovarian, or gastrointestinal/colorectal cancer.
Other: Placebo
Placebo COmparator


Outcome Measures

Primary Outcome Measures :
  1. Incidence of either a chemotherapy dose delay or reduction by [ Time Frame: 17 weeks ]

    The primary endpoint is the subject incidence of either a chemotherapy dose delay by

    ≥ 4 days or a chemotherapy dose reduction by ≥ 15% due to thrombocytopenia in any 2 planned cycles of chemotherapy (chemotherapy cycles can be 14-, 21-, or 28-days long) during the treatment period.



Secondary Outcome Measures :
  1. 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

  2. Platelet Count [ Time Frame: 7 days ]
    7 days after 3rd dose of IP with no transfusions in preceding 7 days

  3. Depth of Platelet Count [ Time Frame: 43 months ]
    3rd dose of IP through end of treatment, up to 43 months

  4. Subject incidence of Platelet Transfusion [ Time Frame: up to 17 weeks ]
    Incidence of Platelet Transfusions through treatment period, up to 17 weeks

  5. Bleeding Events [ Time Frame: up to 17 weeks ]
    Through treatment period, up to 17 weeks

  6. AEs/SAEs [ Time Frame: up to 17 weeks ]
    Through treatment period, up to 17 weeks

  7. Antibody Formation [ Time Frame: up to 17 weeks ]
    Through treatment period, up to 17 weeks

  8. Vital Signs [ Time Frame: up to 43 months ]
    Treatment period thought end of study, up to 43 months

  9. Changes in Health [ Time Frame: up to 43 months ]
    Treatment period thought end of study, up to 43 months


Other Outcome Measures:
  1. Platelet Count [ Time Frame: up to 43 months ]
    Treatment period thought end of study, up to 43 months

  2. Change in Clinical Outcome Assessments (COA) Score [ Time Frame: up to 17 weeks ]

    Change in Patient Global Assessment-CIT (PGA-CIT) scores from week 1 (baseline) to weeks 2 and 3.

    1. 4-item instrument designed to assess global change in quality of life and symptoms over time (since the previous clinic visit).
    2. 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.

  3. Change in Health-Related Quality of Life (HRQoL) Score [ Time Frame: up to 17 weeks ]

    Change in Patient Global Assessment-CIT (PGA-CIT) scores from week 1 (baseline) to weeks 2 and 3.

    1. 4-item instrument designed to assess global change in quality of life and symptoms over time (since the previous clinic visit).
    2. 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.

  4. Romiplostim Concentration [ Time Frame: up to 17 weeks ]
    Through treatment period, up to 17 weeks

  5. Change in Clinical Outcome Assessments (COA) Score [ Time Frame: Up to 17 weeks ]

    European Quality of Life-5 Dimensions (EQ-5D) scores from week 1 (baseline) to weeks 2 and 3.

    1. 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.
    2. 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.

  6. Change in Clinical Outcome Assessments (COA) Score [ Time Frame: Up to 17 weeks ]

    Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores from week 1 (baseline) to weeks 2 and 3.

    Version 4 (for patients with thrombocytopenia) and 2) a patient global assessment - CIT (PGA-CIT) instrument

    1. 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.
    2. 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.

  7. Change in Health-Related Quality of Life (HRQoL) Score [ Time Frame: up to 17 weeks ]

    European Quality of Life-5 Dimensions (EQ-5D) scores from week 1 (baseline) to weeks 2 and 3.

    1. 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.
    2. 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.

  8. Change in Health-Related Quality of Life (HRQoL) Score [ Time Frame: up to 17 weeks ]

    Change in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scores from week 1 (baseline) to weeks 2 and 3.

    Version 4 (for patients with thrombocytopenia) and 2) a patient global assessment - CIT (PGA-CIT) instrument

    1. 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.
    2. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
  • Males or females ≥ 18 years of age at signing of the informed consent.
  • Documented active lung, ovarian, or gastrointestinal/colorectal cancer.
  • Receiving cancer treatment with 14-, 21-, or 28-day cycles, using medication such as alkylating agents, anthracyclines, carboplatin, cisplatin, nucleoside analogs, or any other chemotherapy agents with thrombocytopenia as a warning or adverse reaction.
  • Subjects must have 2 platelet counts < 75 x 109/L at least 21 days apart, as a result of the chemotherapy administered in the cycle immediately preceding study entry, and no platelet count ≥ 100 x 109/L during 3-week period prior to enrollment despite dose delay or dose modification of chemotherapy regimen. The first platelet count < 75 x 109/L may be collected from a local lab platelet count and must be confirmed within the 28-day screening period.
  • Subjects must not have received chemotherapy within 14 days prior to first dose of investigational product.
  • Subjects must have at least 4 additional planned cycles of chemotherapy at study enrollment.
  • Subjects must be able to receive the same chemotherapy regimen (when possible, same schedule and same agents) for at least 2 additional cycles per investigator judgement.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  • Acute lymphoblastic leukemia.
  • Acute myeloid leukemia.
  • Any myeloid malignancy.
  • Myelodysplastic syndrome.
  • Myeloproliferative disease.
  • Multiple myeloma.
  • Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of > 470 msec, pericardial disease, or myocardial infarction.
  • New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening.
  • Known human immunodeficiency virus infection, hepatitis C infection, or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed).
  • Secondary malignancy within the past 5 years except:

    • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    • Adequately treated cervical carcinoma in situ without evidence of disease.
    • Adequately treated breast ductal carcinoma in situ without evidence of disease.
    • Prostatic intraepithelial neoplasia without evidence of prostate cancer.
    • Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
    • Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician (excluding malignancies listed in exclusion criteria 201 - 206).
  • Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor, eltrombopag, recombinant human TPO, any other TPO receptor agonist, or any investigational platelet producing agent.
  • Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT03362177     History of Changes
Other Study ID Numbers: 20140346
2017-002992-25 ( EudraCT Number )
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
Chemotherapy Induced Thrombocytopenia
Lung Cancer
Ovarian Cancer
Gastrointestinal/Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Thrombocytopenia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Blood Platelet Disorders
Hematologic Diseases