Double-blind, placebo-controlled multicenter phase II trial to evaluate the efficacy and safety of romiplostim for the treatment of chemotherapy-induced thrombocytopenia in subjects with relapsed ovarian cancer (2nd or further line)

Double-blind, placebo-controlled multicenter phase II trial to evaluate the efficacy and safety of romiplostim for the treatment of chemotherapy-induced thrombocytopenia in subjects with relapsed ovarian cancer (2nd or further line) - T-RACE II

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002564-69-DE

Enrollment

Registered

2014-01-28

Start date

2014-04-11

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with relapsed ovarian cancer (2nd and 3rd line) treated with chemotherapy according to AGO guidelines who develop thrombocytopenia grade 3 and/or grade 4. MedDRA version: 20.0 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Nplate® Product Name: Romiplostim Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: ROMIPLOSTIM CA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •?Women = 18 years of age •?Before any study-specific procedure, the appropriate written informed consent must be obtained, according to ICH-GCP, and national/local regulation •?ANC = 1,000/µl, Hgb = 9.5 g/dl, and platelet count = 100 x 109/l on day 1 of the first on study cycle of the chemotherapy treatment (on-study cycle) (Thrombocytopenia have to be defined during a “qualifying cycle”; qualifying cycle could be the 1st or the 2nd cycle of the palliative chemotherapy; thrombocytopenia as evidenced by a platelet count =65 years) yes F.1.3.1 Number of subjects for this age range 74

Exclusion criteria

Exclusion criteria: •?Previous treatment with PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), romiplostim, eltrombopag, or another thrombopoietic protein •?Past or current history of malignancies that affect the overall prognosis (Please note: patients with past or current malignancies not affecting the overall progonosis are allowed for enrolment) •?Subjects, who have had a larger surgery within the last 2 weeks before entering this study •?Subjects with an active infection; sepsis, disseminated intravascular coagulation, or any other condition (i.e. myelodysplastic syndrome {MDS}, immune thrombocytopenic purpura {ITP}, thrombotic thrombocytopenic purpura {TTP}, hemolytic uremic syndrome {HUS}) that may have exacerbated thrombocytopenia •?History of unstable angina, CHF {NYHA >class II}, uncontrolled hypertension {diastolic >100mm HG}, uncontrolled cardiac arrhythmia, or recent (within 1 year of screening) myocardial infarction (MI) •?History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 1 year of screening •?History of pulmonary embolism or other venous thrombosis within 1 year of screening (except for catheter-related clots) •?Receipt of any experimental therapy within the last 4 weeks prior to screening; subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study (exception: PROVE study) •?Receipt of a bone marrow or peripheral blood stem cell infusion (within 1 year of screening) •?Positive pregnancy test •?Breast feeding period •?Reproductive potential and not using adequate highly effective methods of contraceptive precautions in the judgment of the investigator during treatment and for 6 month (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidial jelly) •?Known hypersensitivity to any recombinant E. Coli-derived product or any additives •?Inability to comply with the protocol or missing written informed consent •?Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and followup schedule; those conditions should be discussed with the subject before registration in the trial. •?Accommodation in an institution due to official or legal orders (§40 p. 1 No. 4 AMG)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the efficacy of secondary chemotherapy-induced thrombocytopenia prophylaxis with romiplostim in ovarian cancer subjects receiving myelosuppressive chemotherapy, with respect to platelet suppression during the first romiplostim/placebo cycle.;Timepoint(s) of evaluation of this end point: After study medication application; Secondary Objective: • To evaluate the safety of secondary chemotherapy induced thrombocytopenia prophylaxis with romiplostim in ovarian cancer subjects receiving myelosuppressive chemotherapy. •? To show advantageous results in the verum group with respect to other parameters related to platelets and supportive requirements. ; Primary end point(s): To compare the rate of grade 3 to 4 thrombocytopenia in the first treatment cycle (after the qualifying one) by treatment group (nadir value of the platelet counts measured on days 8, 11 or 12, 15 and 18 or 19 [days 18 or 19 are obligatory in cycle 1 only]) as the major efficacy endpoint (with the sample size calculation to be based upon).	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the efficacy of secondary chemotherapy-induced thrombocytopenia prophylaxis with romiplostim in ovarian cancer subjects receiving myelosuppressive chemotherapy, with respect to platelet suppression during the first romiplostim/placebo cycle.;Timepoint(s) of evaluation of this end point: After study medication application; Secondary Objective: • To evaluate the safety of secondary chemotherapy induced thrombocytopenia prophylaxis with romiplostim in ovarian cancer subjects receiving myelosuppressive chemotherapy. •? To show advantageous results in the verum group with respect to other parameters related to platelets and supportive requirements. ; Primary end point(s): To compare the rate of grade 3 to 4 thrombocytopenia in the first treatment cycle (after the qualifying one) by treatment group (nadir value of the platelet counts measured on days 8, 11 or 12, 15 and 18 or 19 [days 18 or 19 are obligatory in cycle 1 only]) as the major efficacy endpoint (with the sample size calculation to be based upon).

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Secondary

Measure	Time frame
Secondary end point(s): The rate of adverse events of grade 3/4 in the first four on-study cycles between the experimental arm and the placebo arm On-study cycle is defined as every therapy cycle after initiation of investigational product. · The rate of grade 3/4 thrombocytopenia in each treatment cycle by treatment group (nadir value of the platelet counts measured on days AG62 / V. 1.0 / 23.04.2013 - 4 - Romiplostim in recurrent ovarian cancer 8, 11 or 12, 15 and 18 or 19 [days 18 or 19 are obligatory in cycle 1 only]) · The average platelet nadir per cycle for each subject in each treatment group during the study (determination of platelet counts on days 8, 11 or 12, 15 and 18 or 19 [days 18 or 19 are obligatory for cycle 1 only]) · The proportion of patients suffering from grade 1, 2, 3, or 4 bleeding events (maximum NCI CTC grade by patient) during on study chemotherapy treatment cycles by treatment group · The proportion of subjects in each treatment group who experience grade 1, 2, 3, or 4 thrombocytopenia (maximum NCI CTC grade by patient) during on study chemotherapy treatment cycles · The duration of grade 3/4 thrombocytopenia experienced during on study chemotherapy treatment cycles. · The number of subjects in each treatment group who are administered platelet transfusions and the rate of administered platelet transfusions during study chemotherapy treatment cycles · The platelet count on day 22 of the on study chemotherapy treatment cycles by treatment group · The proportion of subjects able to receive all CT cycles on time by	—

Measure

Time frame

Secondary end point(s): The rate of adverse events of grade 3/4 in the first four on-study cycles between the experimental arm and the placebo arm On-study cycle is defined as every therapy cycle after initiation of investigational product. · The rate of grade 3/4 thrombocytopenia in each treatment cycle by treatment group (nadir value of the platelet counts measured on days AG62 / V. 1.0 / 23.04.2013 - 4 - Romiplostim in recurrent ovarian cancer 8, 11 or 12, 15 and 18 or 19 [days 18 or 19 are obligatory in cycle 1 only]) · The average platelet nadir per cycle for each subject in each treatment group during the study (determination of platelet counts on days 8, 11 or 12, 15 and 18 or 19 [days 18 or 19 are obligatory for cycle 1 only]) · The proportion of patients suffering from grade 1, 2, 3, or 4 bleeding events (maximum NCI CTC grade by patient) during on study chemotherapy treatment cycles by treatment group · The proportion of subjects in each treatment group who experience grade 1, 2, 3, or 4 thrombocytopenia (maximum NCI CTC grade by patient) during on study chemotherapy treatment cycles · The duration of grade 3/4 thrombocytopenia experienced during on study chemotherapy treatment cycles. · The number of subjects in each treatment group who are administered platelet transfusions and the rate of administered platelet transfusions during study chemotherapy treatment cycles · The platelet count on day 22 of the on study chemotherapy treatment cycles by treatment group · The proportion of subjects able to receive all CT cycles on time by

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Countries

Germany

Contacts

Public ContactStudiensekretariat

Charité Campus Virchow-Klinikum Universitätsmedizin Berlin

004930450564417

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026