Ovarian CancerPhase 2TRACEIINCT03622931
Patients With Relapsed Ovarian Cancer (2nd and 3rd Line) Treated With Chemotherapy According to AGO Guidelines
A Phase 2 study testing Standard chemotherapy and Romiplostim in people with Ovarian Cancer, run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 13 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Standard chemotherapy and Romiplostim
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 13 sitesGermany
- Study dates
- 1 Feb 2014to 17 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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.)
Who cannot join
- 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)
Show all 17Show fewer
- 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)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Praxisklinik für Krebsheilkunde für Frauen Drs. Kittel /Klare / Wetzel
Berlin, 10367
Charité Campus Virchow-Klinikum Universitätsmedizin Berlin
Berlin, 13353
Ev. Waldkrankenhaus Spandau
Berlin, 13589
Gynäkologisches Zentrum
Bonn, 53111
Städtisches Klinikum Brandenburg
Brandenburg, 14770
Gemeinschaftspraxis Dr. Lorenz, Hecker, Wesche
Braunschweig, 38100
Klinikum Chemnitz GmbH
Chemnitz, 09116
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
Dresden, 01307
Universitätsklinikum Jena
Jena, 07743
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Caritasklinik St. Theresia Saarbrücken
Saarbrücken, 66113
Universitätsklinikum Tübingen
Tübingen
About this study
Official title: 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)
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.
Read the detailed description
Chemotherapy of recurrent ovarian cancer leads to severe thrombocytopenia in a considerable proportion of the patients, requiring treatment delays or dose reductions, and placing the patient at a high risk of bleeding complications. The amount of thrombocytopenia is highly schedule-dependent. In platinum-sensitive ovarian cancer that relapsed more than 6 months after end of primary therapy, a platinum containing reinduction therapy - the combination of paclitaxel/carboplatin, gemcitabine/carboplatin or PLD/carboplatin - is recommended according to the current AGO guidelines or recent ASCO presentations. Especially the latter two regimens often induce severe and even dose-limiting myelosuppression, including thrombocytopenia. Therefore, prophylaxis, or at least secondary prophylaxis of this toxicity is an important goal of supportive therapy. The use of platelet transfusions is limited by cost, supply problems, and associated risks, such as transfusion reactions, transmission of infection, and alloimmunization and platelet refractoriness. In contrast to the situation for the red and white blood cell compartments, the implementation of growth factor treatment in order to ameliorate the therapy of thrombocytopenia and its complications, is yet very limited. Romiplostim is an active second-generation thrombopoietic agent without safety problems due to immunogenicity, which proved to be beneficial in the treatment of immune thrombocytopenic purpura and myelodysplastic syndromes. The rationale of this trial is to obtain evidence that romiplostim can improve platelet counts/recovery in the treatment of recurrent ovarian cancer. Due to the fact, that the expected occurrence of severe thrombocytopenia and its complications may heavily depend on the selection of patient and their characteristics such as actually chosen treatment schedule, tumor stage, extent of metastasis, pre-treatment etc. a phase II design comparing the results to historical data or expectations is insufficient. A simple within-group control design, comparing subsequent cycles of the same patients with or without the supportive experimental drug may also be flawed, as "spontaneous" improvements after obviously unchanged chemotherapy are often observed. With some regimens, the first cycle proves to be generally more toxic than later ones. On the other hand, regimens may result in cumulative myelosuppression. A design including a randomized doubleblind control group is therefore warranted, moreover, as platelet counts represent a sensitive and valid surrogate marker for a clinical benefit. The current study will employ a model of secondary prophylaxis. The enrolment of subjects with grade 3 and/or 4 thrombocytopenia will facilitate an assessment of the ability of romiplostim to impact thrombocytopenia at clinically significant levels, which warrant the administration of platelet transfusions, dose reduction, and dose delay.
- Conditions
- Ovarian Cancer
- Being tested
- Standard chemotherapy, Romiplostim, Placebos
- Keywords
- ovarian, cancer, romiplostim, nplate
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard chemotherapyDrug
Chemotherapy
RomiplostimDrug
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Standard chemotherapy; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 and 4 thrombocytopenia
Platelet Count (100 x 10^9/L) will be measured and the rate will be compared by Treatment Group
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (10)
Adverse events of grade 3/4
Determine the rate of AE between the experimental arm and the placebo arm.
Measured: At the end of Cycle 4 (each cycle is 28 days)
Grade 3/4 thrombocytopenia
The rate of AE between the experimental arm and the placebo arm will be determined
Measured: on days 8, 11 or 12, 15
Platelet Counts
The average platelet nadir in each treatment Group will be considered
Measured: on days 8, 11 or 12, 15
Bleeding events
The proportion of patients suffering from grade 1, 2, 3, or 4 bleeding Events will be considered
Measured: At the end of Cycle 8 (each cycle is 28 days)
Grade 1, 2, 3, or 4 thrombocytopenia (maximum NCI CTC grade by patient)
Determine the proportion of subjects in each treatment group
Measured: At the end of Cycle 8 (each cycle is 28 days)
Grade 3/4 thrombocytopenia
The duration will be considered
Measured: At the end of Cycle 8 (each cycle is 28 days)
Platelet transfusions
The number of subjects in each treatment Group will be considered
Measured: At the end of Cycle 8 (each cycle is 28 days)
Platelet counts
The platelet counts on study chemotherapy treatment cycles by treatment group will be considered.
Measured: On day 22 of each Cycle till max. 8 Cycles (each cycle is 28 days)
Counts of CT cycles
The proportion of subjects able to receive all CT cycles on time by treatment group
Measured: through study completion, an average of 8 month
ADR/SADR of romiplostim
Assess the reported ADR/SADR
Measured: through study completion, an average of 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Feb 2014
- Primary completion1 Jan 2019
- Study completion17 Jan 2019
Why it stopped: due to lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jalid Sehouli, Prof. Dr. med., Principal investigator, Frauenklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622931
- Sponsor's protocol ID
- T-RACE II
- Acronym
- TRACEII
- Status last verified
- Feb 2021
- First submitted
- 18 Jan 2018
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03622931
- Acronym / sponsor ID
- TRACEII / T-RACE II
- Conditions
- Ovarian Cancer
- Keywords
- ovarian, cancer, romiplostim, nplate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to lack of recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbHUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chemotherapy of recurrent ovarian cancer leads to severe thrombocytopenia in a considerable proportion of the patients, requiring treatment delays or dose reductions, and placing the patient at a high risk of bleeding complications. The amount of thrombocytopenia is highly schedule-dependent. In platinum-sensitive ovarian cancer that relapsed more than 6 months after end of primary therapy, a platinum containing reinduction therapy - the combination of paclitaxel/carboplatin, gemcitabine/carboplatin or PLD/carboplatin - is recommended according to the current AGO guidelines or recent ASCO presentations. Especially the latter two regimens often induce severe and even dose-limiting myelosuppression, including thrombocytopenia. Therefore, prophylaxis, or at least secondary prophylaxis of this toxicity is an important goal of supportive therapy. The use of platelet transfusions is limited by cost, supply problems, and associated risks, such as transfusion reactions, transmission of infection, and alloimmunization and platelet refractoriness. In contrast to the situation for the red and white blood cell compartments, the implementation of growth factor treatment in order to ameliorate the therapy of thrombocytopenia and its complications, is yet very limited. Romiplostim is an active second-generation thrombopoietic agent without safety problems due to immunogenicity, which proved to be beneficial in the treatment of immune thrombocytopenic purpura and myelodysplastic syndromes. The rationale of this trial is to obtain evidence that romiplostim can improve platelet counts/recovery in the treatment of recurrent ovarian cancer. Due to the fact, that the expected occurrence of severe thrombocytopenia and its complications may heavily depend on the selection of patient and their characteristics such as actually chosen treatment schedule, tumor stage, extent of metastasis, pre-treatment etc. a phase II design comparing the results to historical data or expectations is insufficient. A simple within-group control design, comparing subsequent cycles of the same patients with or without the supportive experimental drug may also be flawed, as "spontaneous" improvements after obviously unchanged chemotherapy are often observed. With some regimens, the first cycle proves to be generally more toxic than later ones. On the other hand, regimens may result in cumulative myelosuppression. A design including a randomized doubleblind control group is therefore warranted, moreover, as platelet counts represent a sensitive and valid surrogate marker for a clinical benefit. The current study will employ a model of secondary prophylaxis. The enrolment of subjects with grade 3 and/or 4 thrombocytopenia will facilitate an assessment of the ability of romiplostim to impact thrombocytopenia at clinically significant levels, which warrant the administration of platelet transfusions, dose reduction, and dose delay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| the experimental arm | Experimental | Drug: Standard chemotherapy, Drug: Romiplostimstandard chemotherapy at 3/4-weekly intervals (cf. inclusion criteria) + romiplostim 750 μg sc once per week for up to 4 cycles |
| the placebo arm | Placebo comparator | Drug: Standard chemotherapy, Drug: Placebosstandard chemotherapy at 3/4-weekly intervals (cf. inclusion criteria) + placebo once per week for up to 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard chemotherapyChemotherapy | Drug | the experimental arm, the placebo arm |
| Romiplostim | Drug | the experimental arm |
| Placebos | Drug | the placebo arm |
Primary outcome
Grade 3 and 4 thrombocytopenia
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Platelet Count (100 x 10^9/L) will be measured and the rate will be compared by Treatment Group
10 secondary outcomes
Adverse events of grade 3/4
Time frame: At the end of Cycle 4 (each cycle is 28 days)
Grade 3/4 thrombocytopenia
Time frame: on days 8, 11 or 12, 15
Platelet Counts
Time frame: on days 8, 11 or 12, 15
Bleeding events
Time frame: At the end of Cycle 8 (each cycle is 28 days)
Grade 1, 2, 3, or 4 thrombocytopenia (maximum NCI CTC grade by patient)
Time frame: At the end of Cycle 8 (each cycle is 28 days)
Grade 3/4 thrombocytopenia
Time frame: At the end of Cycle 8 (each cycle is 28 days)
Platelet transfusions
Time frame: At the end of Cycle 8 (each cycle is 28 days)
Platelet counts
Time frame: On day 22 of each Cycle till max. 8 Cycles (each cycle is 28 days)
Counts of CT cycles
Time frame: through study completion, an average of 8 month
ADR/SADR of romiplostim
Time frame: through study completion, an average of 8 month
Results and safety
The study was stopped early (reason given: due to lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
Related trials for Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Recruiting
Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
High Grade Serous Ovarian Cancer
RecruitingObservational study
Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study
Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jalid Sehouli, Prof. Dr. med. principal investigator
Frauenklinik
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard chemotherapy and Romiplostim in people with Ovarian Cancer, run by Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH at 13 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: due to lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3 and 4 thrombocytopenia (time frame: At the end of Cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.