Romiplostim for Low Platelet Count in Cancer

(RECITE Trial)

No longer recruiting at 182 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Romiplostim, Eltrombopag

Disqualifiers: Leukemia, Myeloma, Heart failure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests romiplostim, a treatment designed to increase platelet count in patients with certain cancers who have low platelets due to chemotherapy. It targets individuals with gastrointestinal, pancreatic, or colorectal cancer who face issues like delayed chemotherapy because of low platelet levels. Participants will receive either romiplostim or a placebo (a harmless, inactive substance) by injection. This trial suits those diagnosed with these cancers and experiencing low platelet counts that disrupt their chemotherapy schedule. As a Phase 3 trial, this study is the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that certain medications like romiplostim and other investigational platelet-producing agents are not allowed if previously used. It's best to discuss your current medications with the trial team to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that romiplostim, a treatment being tested for low platelet counts in cancer patients, has promising safety results in other conditions. Specifically, patients with immune thrombocytopenia (ITP), which also causes low platelet counts, maintained healthy platelet levels for several weeks when treated with romiplostim. Studies found that 87% of these patients responded well, with significant increases in their platelet counts.

Moreover, the FDA has already approved romiplostim for use in ITP, indicating it is generally well-tolerated. While every treatment can have side effects, existing evidence shows that romiplostim is usually safe for people who need help with their platelet counts. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for low platelet count in cancer?

Romiplostim is unique because it specifically targets low platelet counts in cancer patients by mimicking thrombopoietin, a natural protein that stimulates platelet production. Unlike typical treatments that might involve platelet transfusions or drugs like corticosteroids, romiplostim works directly at the cellular level to boost the body's own ability to produce platelets. Researchers are excited about this treatment because it has the potential to offer a more consistent and long-term solution for managing low platelet counts, which can significantly improve the quality of life for cancer patients.

What evidence suggests that Romiplostim might be an effective treatment for low platelet count in cancer?

Research has shown that romiplostim, which participants in this trial may receive, can effectively increase platelet counts in patients with low platelets due to chemotherapy. In one study, 85% of patients treated with romiplostim responded positively. Another study found that 71% of patients benefited, and 79% could continue their chemotherapy without delays or dose reductions. Additionally, a separate analysis reported a 93% success rate in restoring platelet counts to healthy levels within three weeks. These findings suggest that romiplostim has strong potential to help manage low platelets in cancer patients. Participants in this trial will be randomized to receive either romiplostim or a placebo. ^{2 3 6 7 8}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Adults over 18 with gastrointestinal, pancreatic, or colorectal cancer experiencing low platelet counts due to chemotherapy can join. They must be on certain chemo regimens and have at least 3 cycles left. Excluded are those with other blood disorders, recent major surgery or thrombosis, active infections including HIV and hepatitis B/C, pregnancy/breastfeeding women not using contraception, and anyone who's used similar drugs before.

Inclusion Criteria

I am able to care for myself and perform daily activities.

I finished my last chemotherapy cycle at least 14 or 21 days ago, depending on the type.

I have at least 3 chemotherapy sessions left.

Exclusion Criteria

Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

I have acute lymphoblastic leukemia.

Subject has known sensitivity to any of the products to be administered during dosing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive romiplostim or placebo as a subcutaneous injection during chemotherapy cycles

48 days

Multiple visits for each chemotherapy cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Romiplostim

Trial Overview The trial is testing Romiplostim against a placebo in patients with specific cancers who have developed thrombocytopenia from chemotherapy. The goal is to see if Romiplostim can increase their platelet counts and allow them to continue chemotherapy without delay.

How Is the Trial Designed?

Group I: Romiplostim Experimental Treatment 1 Intervention

Participants will be enrolled to the study in a 2:1 randomization ratio. Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

Group II: Placebo Placebo Group 1 Intervention

Participants will be enrolled to the study in a 2:1 randomization ratio. Amgen investigational product (romiplostim or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection.

Romiplostim is already approved in European Union, United States for the following indications:

Approved in European Union as Nplate for:

• Chronic immune thrombocytopenia
• Hematopoietic syndrome associated with acute radiation syndrome

Approved in United States as Nplate for:

• Chronic immune thrombocytopenia
• Hematopoietic syndrome associated with acute radiation syndrome

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11319220/

Romiplostim in chemotherapy‐induced thrombocytopenia Including patients treated with romiplostim in an additional single‐arm cohort, 85% (44/52) of all romiplostim‐treated patients responded with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00111475

Study Details | NCT00111475 | Evaluating the Safety and ... The primary objective of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with ITP.

3. haematologica.org haematologica.org/article/view/9776

A multicenter study of romiplostim for chemotherapy ... Romiplostim was effective in solid tumor patients: 71% of patients achieved a romiplostim response, 79% avoided chemotherapy dose reductions/treatment delays ...

4. ashpublications.org ashpublications.org/blood/article/113/10/2161/24354/Safety-and-efficacy-of-long-term-treatment-with

Safety and efficacy of long-term treatment with romiplostim in ... Platelet responses (platelet count ≥ 50 × 109/L and double baseline) were observed in 87% of all patients and occurred on average 67% of the time in responding ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.18.01931

Romiplostim Treatment of Chemotherapy-Induced ... In an interim analysis, the success rate of romiplostim in correcting the platelet count to 100,000/μL within 3 weeks was 93%, whereas there was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4888762/

Long-term safety and efficacy of romiplostim for treatment ... Patients treated with romiplostim were able to maintain a platelet count of ≥50×109/L for a mean of 15.2 weeks in the nonsplenectomy group, and 12.3 weeks in ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2008/125268s000_PharmR.pdf

Nplate (romiplostim) - accessdata.fda.gov In BDF1 mice with or without splenectomy, AMG 531 (10-100 mcg/kg) produced similar degree of increase in platelet count (2 to 4-fold) suggesting ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3627322/

The efficacy and safety of romiplostim in adult patients ... In vivo work using rhesus monkeys showed that a single dose of romiplostim led to a dose-dependent increase in platelet count at day 5 with a peak between days ...