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New treatment option for Paget Disease, Extramammary
Official title Multi-cohort, Single-arm Phase II Study of Albumin-paclitaxel, Ifosfamide, and Cisplatin in the Treatment of Rare Advanced Tumors
ClinicalTrials.gov ID: NCT06684327
What this study is testing
What is Albumin-paclitaxel Injection?
Albumin-paclitaxel Injection is an investigational medicine, being studied as a potential treatment for paget disease, extramammary.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if albumin-paclitaxel, ifosfamide and cisplatin (Nab-TIP) works to treat advanced rare tumors including PAGET's disease of scrotum with infiltrating sweat gland carcinoma （cohort 1）, rhabdomyosarcoma (cohort 2), testicular cancer (cohort 3), penile cancer (cohort 4), and urachus cancer (cohort 5) . It will also learn about the safety of Nab-TIP.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Individuals able to understand and give written informed consent.
- Histologically or cytologically confirmed cancer of one of the following types: PAGET's disease of scrotum with infiltrating sweat gland carcinoma...
- Stage IV disease
- Adequate performance status (ECOG 0-2)
- Expected survival ≥ 3 months.
You likely can't join if
- 1\. Active or uncontrolled severe infections (≥CTCAE Level 2) requiring systemic antibacterial, antifungal, or antiviral therapy, including...
- 2\. Active hepatitis (transaminases not within inclusion criteria; HBV reference: HBV DNA ≥2000 IU/ml or ≥10\^4 copies/ml; HCV reference: HCV RNA...
- 3\. Renal failure requiring hemodialysis or peritoneal dialysis.
- 4\. History of immunodeficiency, including HIV positive or having other acquired/congenital immunodeficiency diseases, or organ transplant history.
- 5\. Severe nausea, headache, insomnia, fatigue, somnolence, dry mouth, dizziness, and constipation.
- 6\. History of active tuberculosis.
See the full eligibility criteria
- Individuals able to understand and give written informed consent.
- Histologically or cytologically confirmed cancer of one of the following types: PAGET's disease of scrotum with infiltrating sweat gland carcinoma Rhabdomyosarcoma Testicular cancer Penile cancer Urachal cancer
- Stage IV disease
- Adequate performance status (ECOG 0-2)
- Expected survival ≥ 3 months.
- Measurable disease by CT or MRI, Or lesions with skin infiltration.
- Adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dL, absolute neutrophil count (ANC) \> 1,500 per mm\^3, platelets \> 100,000 per mm\^3).
- Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit of normal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if...
- Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN.
- Willing to use a medically approved contraceptive method from the enrollment to at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction...
- Ability to comply with research visit schedules and other protocol requirements.
- 1\. Active or uncontrolled severe infections (≥CTCAE Level 2) requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infections.
- 2\. Active hepatitis (transaminases not within inclusion criteria; HBV reference: HBV DNA ≥2000 IU/ml or ≥10\^4 copies/ml; HCV reference: HCV RNA ≥2000 IU/ml or ≥10\^4 copies/ml; after nucleoside antiviral treatment...
- 3\. Renal failure requiring hemodialysis or peritoneal dialysis.
- 4\. History of immunodeficiency, including HIV positive or having other acquired/congenital immunodeficiency diseases, or organ transplant history.
- 5\. Severe nausea, headache, insomnia, fatigue, somnolence, dry mouth, dizziness, and constipation.
- 6\. History of active tuberculosis.
- 7\. Uncontrolled ascites, pleural effusion, or pericardial effusion requiring repeated drainage.
- 8\. Patients who have undergone major organ transplantation.
- 9\. Individuals who have undergone major surgical procedures, open biopsies, or obvious traumatic injuries within 28 days prior to the start of the study; or have unhealed wounds or fractures for a long time;
- 10\. Individuals who have participated or are currently participating in another clinical study within the past 4 weeks prior to the start of the study;
- 11\. Individuals with a history of severe allergies;
- 12\. Individuals at risk of bleeding, or with impaired coagulation function, or who are currently receiving thrombolytic therapy;
- 13\. Individuals with a history of substance abuse with no ability to abstain or with a mental disorder.
- 14\. According to the investigator's judgment, people with serious adverse effects on their safety or completion of the study, or those with accompanying diseases that seriously endanger the safety of the people or...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.