Romiplostim for Low Platelet Count in Cancer

(RECITE Trial)

Recruiting at 135 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

165 Participants Needed

Trial Summary

What is the purpose of this trial?

Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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