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

NCT03622931 | Terminated Phase 2

• 1 other identifier: T-RACE II
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Ovarian Cancer

Keywords

ovarian; cancer; romiplostim; nplate

Outcome Measures

Primary Outcomes (1)

• Grade 3 and 4 thrombocytopenia

  Platelet Count (100 x 10\^9/L) will be measured and the rate will be compared by Treatment Group

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

Secondary Outcomes (10)

• Adverse events of grade 3/4

  At the end of Cycle 4 (each cycle is 28 days)

• Grade 3/4 thrombocytopenia

  on days 8, 11 or 12, 15

• Platelet Counts

  on days 8, 11 or 12, 15

• Bleeding events

  At the end of Cycle 8 (each cycle is 28 days)

• Grade 1, 2, 3, or 4 thrombocytopenia (maximum NCI CTC grade by patient)

  At the end of Cycle 8 (each cycle is 28 days)

Study Arms (2)

the experimental arm

EXPERIMENTAL

standard chemotherapy at 3/4-weekly intervals (cf. inclusion criteria) + romiplostim 750 μg sc once per week for up to 4 cycles

Drug: Standard chemotherapy; Drug: Romiplostim

the placebo arm

PLACEBO COMPARATOR

standard chemotherapy at 3/4-weekly intervals (cf. inclusion criteria) + placebo once per week for up to 4 cycles

Drug: Standard chemotherapy; Drug: Placebos

Interventions

Standard chemotherapy DRUG

Chemotherapy

the experimental arm; the placebo arm

Romiplostim DRUG

the experimental arm

Placebos DRUG

the placebo arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH: lead

Study Sites (13)

Praxisklinik für Krebsheilkunde für Frauen Drs. Kittel /Klare / Wetzel

Berlin, 10367, Germany

Location

Charité Campus Virchow-Klinikum Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Ev. Waldkrankenhaus Spandau

Berlin, 13589, Germany

Location

Gynäkologisches Zentrum

Bonn, 53111, Germany

Location

Städtisches Klinikum Brandenburg

Brandenburg, 14770, Germany

Location

Gemeinschaftspraxis Dr. Lorenz, Hecker, Wesche

Braunschweig, 38100, Germany

Location

Klinikum Chemnitz GmbH

Chemnitz, 09116, Germany

Location

Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Jena

Jena, 07743, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Caritasklinik St. Theresia Saarbrücken

Saarbrücken, 66113, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Jalid Sehouli, Prof. Dr. med.

  Frauenklinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 74 patients (about 37 in the experimental and 37 in the placebo arm), evaluable for the principal efficacy endpoint, are required. These will be recruited from an expected number of 15 sites.

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: August 9, 2018
• Study Start: February 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 17, 2019
• Last Updated: February 8, 2021

Record last verified: 2021-02

Locations

DE (13)