Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors
Recruiting
Phase 2
Interventional Study
Persistent Isolated Chemotherapy-Induced Thrombocytopenia
Chemotherapy-Induced Thrombocytopenia
Gynecologic Cancers
Ovarian Cancer
Breast Cancer
Lung Cancer
Non-Small Cell Lung Cancer
Cervical Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 220 (estimated)
- Sponsor
- Peking University People's Hospital · Other
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About This Trial
This is a prospective, randomized, open-label, active-controlled study to evaluate the efficacy and safety of Romiplostim N01 plus all-trans retinoic acid (ATRA) compared with Romiplostim N01 alone in adults with persistent isolated chemotherapy-induced thrombocytopenia (PICIT) after complete remission of selected gynecologic, breast, or lung solid tumors, including but not limited to non-small ce…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 18 years or older.
2. Prior diagnosis of a selected gynecologic, breast, or lung solid tumor, including but not limited to non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer. Other eligible tumor types may include endometrial cancer, cervical cancer, fal…
Contacts