Patients With Relapsed Ovarian Cancer (2nd and 3rd Line) Treated With Chemotherapy According to AGO Guidelines

• Status: Terminated
• Trial end date: 2019-01-17
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the safety of secondary chemotherapy induced thrombocytopenia (reduction in platelets which leads to bleeding) prophylaxis with romiplostim in ovarian cancer subjects receiving myelosuppressive (blood cell damaging) chemotherapy.It is anticipated that Romiplostim, when administered at an effective dose and schedule, will be a well-tolerated treatment for subjects experiencing chemotherapy-induced thrombocytopenia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH; Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH

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 < 50 x 109/l during the qualifying cycle of chemotherapy OR platelet count < 100 x 109/l on the planned starting day of the next cycle of chemotherapy (or 1-3 days before), requiring dose delay for platelet recovery.)

• Subjects with histologically confirmed advanced or metastatic ovarian cancer, fallopian tube cancer, peritoneal carcinoma or ovarian carcinosarcoma who are receiving 2nd or further line chemotherapy consisting of one of the following regimens according to established dosing standards:

1. Topotecan, d 1-5, q3w

2. Gemcitabine, d1+8, q3w

3. Carboplatin / paclitaxel, d1, q3w

4. Carboplatin d1 /gemcitabine, d1+d8, q3w

5. Carboplatin / pegylated liposomal doxorubicin, d1, q4w

6. Carboplatin d1 / gemcitabine, d1+d8, Avastin d1, q3w

7. Topotecan d1-5 + avastin, q3w

8. Carboplatin + paclitaxel + avastin, q3w

• Thrombocytopenia as evidenced by a platelet count < 50 x 109/l during the qualifying cycle of chemotherapy OR platelet count < 100 x 109/l on the planned starting day of the next cycle of chemotherapy (or 1-3 days before), requiring dose delay for platelet recovery; qualifying cycle could be the 1st or the 2nd cycle of chemotherapy

• Life expectancy ≥ 12 weeks at the time of screening

• Ability to receive the same dose and schedule of chemotherapy during the first on study treatment cycle as was given in the qualifying cycle(s). (In case of grade 4 thrombocytopenia: a dose reduction to ≥75% of the previous dose schedule is allowed.)

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 prognosis are allowed for enrollment)

• Subjects, who have had a larger surgery within the last 2 weeks before entering this study

• Active participation in any other clinical 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 follow-up 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)