TerminatedPhase 2

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

Stopped: due to lack of recruitment

Germany21 participantsStarted 2014-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Topotecan, d 1-5, q3w
✓. Gemcitabine, d1+8, q3w
✓. Carboplatin / paclitaxel, d1, q3w
✓. Carboplatin d1 /gemcitabine, d1+d8, q3w
✓. Carboplatin / pegylated liposomal doxorubicin, d1, q4w
✓. Carboplatin d1 / gemcitabine, d1+d8, Avastin d1, q3w
✓. Topotecan d1-5 + avastin, q3w
✓. Carboplatin + paclitaxel + avastin, q3w

What they're measuring

Grade 3 and 4 thrombocytopenia

Timeframe: At the end of Cycle 1 (each cycle is 28 days)

Trial details

NCT IDNCT03622931

SponsorGesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-01

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