Study of romiplostim for treating low platelet counts caused by chemotherapy in adults with non-small cell lung cancer, ovarian cancer, or breast cancer

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What is this study about?

This study examines treatment for low platelet counts caused by chemotherapy in adults with non-small cell lung cancer, ovarian cancer, or breast cancer. Platelets are blood cells that help stop bleeding, and chemotherapy can lower their numbers, sometimes requiring doctors to delay or reduce cancer treatment doses. The study uses a medication called romiplostim, which is also known by the code name AMG 531, or placebo. Romiplostim is designed to help the body make more platelets. Participants will receive chemotherapy containing carboplatin combined with other cancer drugs such as gemcitabine, pemetrexed, liposomal doxorubicin, paclitaxel, nab-paclitaxel, or docetaxel. Some participants may also receive additional treatments like bevacizumab or other targeted therapies.

The purpose of this study is to find out if romiplostim can help maintain platelet counts high enough to allow patients to receive their full chemotherapy doses on time without delays or reductions. The study will compare romiplostim with placebo to measure its effectiveness. Participants entering the study must have a platelet count at or below a certain level and must have at least three more cycles of chemotherapy planned. The chemotherapy cycles are given every 21 or 28 days depending on the specific treatment plan.

During the study, participants will receive either romiplostim or placebo as an injection under the skin while continuing their regular chemotherapy treatment. The study medication will be given for a treatment period lasting up to 12 weeks. Doctors will monitor platelet counts, track whether chemotherapy doses need to be changed due to low platelets, and watch for any bleeding problems or other side effects. Participants will continue to be followed for safety monitoring for up to 36 months to check for any long-term effects.

1 Initial enrollment and baseline assessment

At the beginning of the study, a platelet count (blood cells that help with clotting) will be measured. This count must be at or below 85 x 10⁹ per liter.

At least 21 or 28 days must have passed since the start of the previous chemotherapy cycle, depending on whether the chemotherapy is given every 21 or 28 days.

At this point, at least 3 more cycles of chemotherapy must be planned.

2 Treatment period with study medication

The study medication will be administered during the chemotherapy treatment period. Either romiplostim (the active study drug) or placebo (an inactive substance) will be given.

Romiplostim is provided as Nplate 500 micrograms powder, which is mixed with sterile water and given as an injection under the skin (subcutaneous injection).

The placebo looks identical to the active medication and is also given as an injection under the skin.

The treatment will be given alongside the planned chemotherapy regimen, which includes medications containing carboplatin combined with other drugs such as gemcitabine, pemetrexed, liposomal doxorubicin, or taxanes (paclitaxel, nab-paclitaxel, or docetaxel).

The chemotherapy cycles will continue every 21 or 28 days, depending on the specific regimen.

The treatment period lasts for 48 days, covering the second and third cycles of chemotherapy.

3 Monitoring during treatment

Throughout the treatment period, platelet counts will be monitored regularly to assess how the blood is responding to the study medication.

The lowest point of the platelet count (called the nadir) will be measured from the start of the first chemotherapy cycle through the end of the treatment period.

Any need for platelet transfusions (receiving platelets from a donor) will be recorded.

Any bleeding events of grade 2 or higher will be monitored and documented.

Blood samples will be collected to check for the development of antibodies (proteins the body makes in response to the medication).

Any changes in chemotherapy dosing, including dose reductions, delays, or treatment discontinuation due to low platelet counts (below 100 x 10⁹ per liter), will be recorded.

4 Assessment after third dose

Seven days after receiving the third dose of the study medication, the platelet count will be checked to determine if it has reached at least 100 x 10⁹ per liter without any platelet transfusions in the preceding 7 days.

5 End of treatment period

The active treatment period concludes after 48 days, which covers the second and third chemotherapy cycles.

At the end of this period, all adverse events (unwanted medical occurrences) will be documented.

Laboratory values will be reviewed for any clinically significant changes.

6 Long-term follow-up

Follow-up will continue for up to 36 months (3 years) after the treatment period.

During this time, overall survival will be tracked, with a specific assessment at 1 year.

Monitoring will continue for the development of anti-romiplostim antibodies and anti-TPO antibodies (antibodies against thrombopoietin, a natural protein that stimulates platelet production).

Any occurrence of myelodysplastic syndromes (a group of disorders where the bone marrow does not produce enough healthy blood cells) will be monitored.

Any secondary malignancies (new cancers that develop) will be documented.

All adverse events, including serious adverse events and fatal adverse events, will continue to be recorded throughout the follow-up period.

Who Can Join the Study?

To be eligible for this clinical trial, you must meet all of the following requirements:

You must provide your written agreement to participate in the study before any study procedures begin, or if you have a condition that affects your ability to provide consent, your legal representative can provide this agreement on your behalf
You must be 18 years of age or older at the time of signing the consent form
You must have confirmed non-small cell lung cancer, which is a type of lung cancer, breast cancer, or ovarian cancer, including cancer of the fallopian tubes or the lining of the abdomen, at stage I, II, III, or IV that has spread locally or to other parts of the body, or cancer that has come back at any stage. If you have stage III lung cancer, you should not be suitable for treatment with combined radiation and chemotherapy or surgery
You must be receiving cancer treatment in cycles that repeat every 21 or 28 days, using specific chemotherapy combinations that include carboplatin, which is a platinum-based cancer drug, combined with one of these drugs: gemcitabine, pemetrexed, liposomal doxorubicin, or taxane drugs such as paclitaxel, nab-paclitaxel, or docetaxel. You may also be receiving single drug treatment with any of these medications. Your treatment may also include additional drugs such as anti-angiogenic agents like bevacizumab, which stops blood vessel growth in tumors, targeted therapy drugs, or immune checkpoint inhibitors. Or, you must have low platelet counts from a previous chemotherapy regimen and are planning to start one of the approved chemotherapy regimens listed above, but this has been delayed by at least one week due to low platelet counts
Your platelet count, which are blood cells that help with clotting, must be 85 or lower when measured using units of billions per liter on the first day of the study
You must be at least 21 or 28 days past the start of your last chemotherapy cycle before joining the study, depending on whether you receive treatment every 21 or 28 days
You must have at least 3 more planned cycles of chemotherapy remaining when you join the study
Your physical condition must be rated as 0, 1, or 2 on the ECOG performance status scale, which is a measure of how well you can perform daily activities, where 0 means you are fully active, 1 means you can do light work, and 2 means you can care for yourself but cannot work

Who Cannot Join the Study?

No exclusion criteria have been specified in the available study information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Medisprof S.R.L.	Cluj Napoca	Romania

Other Sites

Site Name	City	Country
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Oncolab S.R.L.	Craiova	Romania
University General Hospital Of Heraklion	Heraklion	Greece
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Hospital Universitario De Fuenlabrada	Fuenlabrada	Spain
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Spitalul Municipal Ploiesti	Ploiesti	Romania
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal
Henry Dunant Hospital Center	Athens	Greece
Saint Savvas Oncology Hospital	Athens	Greece
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu	Balotesti	Romania
Hospital Quironsalud Barcelona	Barcelona	Spain
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego	Walbrzych	Poland
Spitalul Clinic Coltea	Bucharest	Romania
Virgen del Rocío University Hospital	Sevilla	Spain
Alexandra Hospital	Athens	Greece
Hospital Universitario Virgen De Valme	Sevilla	Spain
Oncomed S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
St. Luke’s Hospital S.A.	Thessaloniki	Greece
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Spitalul De Oncologie Monza S.R.L.	Bucharest	Romania
Provita Centrum Medyczne Sp. z o.o.	Tomaszow Mazowiecki	Poland
Dbfcypmkrckd Cthttrc Ocuqidnqz Pjgmbvnyiejy I Hkvbbtnjcnh	Wroclaw	Poland
Ugiyyrhnlhucy Seovdag Kubuunhrk Ng 2 Phc W Sngbganarh	Szczecin	Poland
Anaxki Mgylhuh Cnvmgg Skbw	Thessaloniki	Greece
Wwtlrdrlav Swqfsde Icq Sbhxzup Pde W Pmolircpx	Przemysl	Poland

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	12.08.2020
Poland	Not recruiting	12.08.2020
Portugal	Not recruiting	12.08.2020
Romania	Not recruiting	12.08.2020
Spain	Not recruiting	12.08.2020

Trial locations

Investigated drugs:

Romiplostim

Romiplostim is a medication being tested in this clinical trial to help treat low platelet counts (thrombocytopenia) that can happen as a side effect of chemotherapy. Platelets are blood cells that help your blood clot and stop bleeding. When chemotherapy lowers your platelet count too much, it can cause delays in your cancer treatment or require dose reductions. Romiplostim works by stimulating your body to make more platelets, which may help you stay on schedule with your full chemotherapy doses without interruption.

Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in this study to compare against romiplostim to help researchers understand if romiplostim truly works better than no treatment for preventing low platelet counts during chemotherapy.

Non-small Cell Lung Cancer – Non-small cell lung cancer is a type of cancer that begins in the lungs and accounts for the majority of lung cancer cases. The disease develops when cells in the lung tissue grow abnormally and form tumors. As the cancer progresses, it can spread to nearby tissues and lymph nodes. In advanced stages, the cancer may spread to other parts of the body through the bloodstream. The disease often develops slowly compared to other types of lung cancer. Symptoms may include persistent cough, chest pain, shortness of breath, and coughing up blood.

Ovarian Cancer – Ovarian cancer is a disease that starts in the ovaries, the female reproductive organs that produce eggs. The cancer begins when cells in the ovaries start to grow out of control and form tumors. As the disease progresses, cancer cells can spread to the lining of the abdomen and other nearby organs. In later stages, the cancer may spread to more distant parts of the body. Early stages of ovarian cancer often produce few or no symptoms. As the disease advances, symptoms may include abdominal bloating, pelvic pain, difficulty eating, and frequent urination.

Breast Cancer – Breast cancer is a disease in which cells in breast tissue grow abnormally and form a tumor. The cancer typically begins in the milk ducts or the glands that produce milk. As the disease develops, the tumor can grow larger and invade surrounding breast tissue. Cancer cells may spread to nearby lymph nodes under the arm or near the collarbone. In advanced stages, the cancer can spread through the bloodstream to other organs such as bones, liver, or lungs. Common signs include a lump in the breast, changes in breast shape or size, skin changes, and nipple discharge.

Chemotherapy-induced Thrombocytopenia – Chemotherapy-induced thrombocytopenia is a condition that occurs when cancer treatment with chemotherapy drugs causes a decrease in the number of platelets in the blood. Platelets are blood cells that help with clotting and stop bleeding. The condition develops because chemotherapy drugs affect the bone marrow, where platelets are produced. As platelet counts drop, patients become more prone to bruising and bleeding. The severity can range from mild decreases in platelet counts to more significant reductions that require medical attention. This condition typically improves once chemotherapy treatment is completed or adjusted.

Trial ID:

2023-507149-27-00

Protocol code:

20170770

NCT ID:

NCT03937154

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of romiplostim for treating low platelet counts caused by chemotherapy in adults with non-small cell lung cancer, ovarian cancer, or breast cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?