CLINICAL TRIALS PROFILE FOR AIR POLYMER-TYPE A
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505(b)(2) Clinical Trials for Air Polymer-type A
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT04026945 ↗ | Sustained Release Lidocaine for Treatment of Scrotal Pain | Completed | University of British Columbia | Phase 1/Phase 2 | 2019-10-31 | In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing chronic scrotal pain (CSCP). The new formulation ST-CP is a lidocaine sustained-release formulation and is expected to provide pain relief over 4 weeks. Currently, the drug lidocaine is not available as an injectable slow-release formulation and chronic scrotal pain patients are often left untreated. |
| New Formulation | NCT05193227 ↗ | Sustained Release Lidocaine for the Treatment of Postoperative Pain | Recruiting | University of British Columbia | Phase 2 | 2021-10-27 | In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing postoperative pain after pelvic surgery. The new formulation ST-01 is a sustained release lidocaine formulation and is expected to provide pain relief over multiple days. Currently, the drug lidocaine is not available as an injectable slow-release formulation. |
| New Formulation | NCT07359053 ↗ | MAGNATE-S: Paclitaxel Polymer Micelles Combo in Advanced Sarcoma | RECRUITING | Shanghai 6th People's Hospital | PHASE2 | 2025-12-25 | What is this study about? This is a medical research study testing a new drug combination ("Paclitaxel Polymer Micelles" + "Gemcitabine" + "Targeted Therapy") for patients with locally advanced unresectable or metastatic bone and soft tissue sarcomas whose disease has progressed after first-line standard therapy. Currently, there is a lack of highly effective subsequent treatment options for these patients. Why is this study being done? To improve efficacy: the investigators hope this drug combination can control tumor growth more effectively than current treatments. To reduce toxicity: The "Paclitaxel Polymer Micelles" used in the study is a new formulation that may be safer than traditional paclitaxel, with a lower risk of severe allergic reactions. For precise treatment: the investigators will select different targeted drugs (Lenvatinib for bone sarcoma or Anlotinib for soft tissue sarcoma) based on the tumor type, aiming for more tailored therapy. How will the study be conducted? Design: This is an exploratory study, planning to enroll approximately 46 patients in total, divided into two separate groups (23 for bone sarcoma, 23 for soft tissue sarcoma). Process: Eligible and consenting patients will receive periodic combined drug therapy. Doctors will regularly evaluate efficacy and monitor safety through blood tests, US, CT, or MRI scans. Primary Goal: The main focus is to see how many patients experience significant tumor shrinkage (Objective Response Rate), and to record all adverse reactions that occur. Biomarker Research: To better understand treatment mechanisms and identify potential predictive markers, this study includes the collection of biological samples for future research, with careful design to minimize additional burden. Small extra blood samples will be collected during scheduled routine blood draws required for clinical monitoring. If a tumor biopsy or surgery is performed as part of necessary clinical care, the investigators will request permission to preserve a portion of the remaining tissue that would otherwise be discarded. These samples may be analyzed using techniques such as genetic or protein testing. What does this mean for participants? Potential Benefits: Participants have the opportunity to receive the new drug "Paclitaxel Polymer Micelles" free of charge and may benefit from it. Their participation will provide valuable treatment experience for all future patients with similar conditions. Potential Risks: The drug combination may increase the risk of certain side effects, such as fatigue, nausea, high blood pressure, hand-foot skin reactions, or decreased blood cell counts. The research team has developed detailed plans to prevent and manage these situations. Voluntary Principle: Participation is completely voluntary. Patients have the right to withdraw from the study at any time, for any reason, without affecting their right to receive other routine medical care. In summary, this study explores a regimen combining a novel nano-drug, chemotherapy, and precise targeted therapy, aiming to find a more effective and safer treatment option for patients with advanced bone and soft tissue sarcomas who have failed first-line treatment. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Air Polymer-type A
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00003876 ↗ | Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma | Completed | Barrett Cancer Center | Phase 1 | 1999-04-01 | RATIONALE: Internal radiation uses high-energy radiation to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining internal radiation therapy with chemotherapy implants may kill remaining tumor cells following surgery. PURPOSE: Phase I trial to study the effectiveness of internal radiation therapy plus carmustine implants in treating patients who have recurrent or refractory malignant glioma. |
| NCT00003878 ↗ | Carmustine Implants in Treating Patients With Brain Metastases | Completed | National Cancer Institute (NCI) | Phase 2 | 2002-04-01 | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor. |
| NCT00003878 ↗ | Carmustine Implants in Treating Patients With Brain Metastases | Completed | New Approaches to Brain Tumor Therapy Consortium | Phase 2 | 2002-04-01 | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor. |
| NCT00004315 ↗ | Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease | Unknown status | Children's Hospital Medical Center, Cincinnati | Phase 2 | 1995-11-01 | OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments. |
| NCT00004315 ↗ | Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease | Unknown status | National Center for Research Resources (NCRR) | Phase 2 | 1995-11-01 | OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments. |
| NCT00005783 ↗ | A Phase I/II Trial of Recombinant-Methionyl Human Stem Cell Factor (SCF) in Adult Patients With Sickling Disorders | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 1 | 2000-03-01 | Sickle cell anemia is a genetic disorder that results from a single nucleotide substitution in codon 6 of the beta-globin gene which, in the homozygous state, produces an abnormal hemoglobin that is prone to polymer formation when deoxygenated. The polymerized hemoglobin leads to impaired deformability and sickling of red blood cells which subsequently lodge in end-arterioles producing the classic and most prominent feature of the disorder, repeated vasoocclusive crises. Despite knowledge of the precise genetic defect for decades, only recently has there been therapeutic impact based upon this knowledge when a clear benefit from treatment with hydroxyurea, a cell cycle-specific agent administered to induce production of fetal hemoglobin (HbF) by stimulating gamma-globin synthesis, was reported in patients with sickle cell disease (SCD). The reduction in the frequency and severity of vasoocclusive crises seen has been attributed to the increase in HbF levels in responsive patients. While the majority of patients demonstrate a rise in HbF, not all such patients benefit from treatment. Given these results, alternative agents that also stimulate the production of HbF warrant investigation in the treatment of SCD. Recombinant-methionyl human stem cell factor (SCF) is a hematopoietic growth factor with activity on immature hematopoietic progenitor cells. SCF stimulates the production of HbF in vitro and in vivo, and this effect is attainable without the myelosuppression associated with hydroxyurea. In this phase I/II trial, we will administer SCF in a dose escalating fashion to patients with sickling disorders. Parameters to be measured are HbF levels, F cell levels, peripheral blood CD34 levels, frequency, duration, and severity of vasoocclusive crises, and toxicity. |
| NCT00063765 ↗ | Evaluation of Safety of Ciliary Neurotrophic Factor Implants in the Eye | Completed | National Eye Institute (NEI) | Phase 1 | 2003-06-01 | This study will evaluate the safety of a ciliary neurotrophic factor (CNTF) implant placed in the eye to allow the release of CNTF directly on the retina. The results of this study may lead to a larger investigation of CNTF implants to treat retinitis pigmentosa (RP), a progressive degenerative eye disease that begins with loss of peripheral vision and night blindness and often leads to blindness in later life. Currently, there are no effective treatments for RP. Researchers have found, however, that certain proteins, called ciliary neurotrophic factor (CNTF), can partially protect cells in the eye if given directly inside the eye. A major challenge in treating RP is to deliver medicine directly into the eye. One way to ensure that CNTF gets into the eye is to surgically place an implant inside the eye to release the protein. Patients 18 years of age and older with retinitis pigmentosa whose visual acuity is 20/100 or worse may be eligible for this study. Candidates will be screened with a medical history, physical examination, eye examinations, and eye photographs. The eye examination includes measurement of visual acuity and eye pressure, examination of the pupils and eye movements, and examination of the lens and back of the eye. In addition, patients will have the following tests: - Visual field test: Patients look at a central spot on a white screen and tell the examiner whenever they see a small light appear at other places on the screen. - Electroretinogram (ERG): Electrodes are taped to the patient's forehead. Special contact lenses are placed on the eyes, similar to normal contact lenses, after the eye has been numbed with drops. The contact lenses sense small electrical signals generated by the retina. The ERG measures the electrical activity of the retina when it is stimulated by light. For the ERG recording, the patient looks inside a large, hollow, dark sphere, and sees flashes of light, first in the dark, and then with a light turned on in the sphere. - Optical coherence tomography: This test, done with the machine used to examine the eye, measures retinal thickness by producing cross-sectional pictures of the retina. Participants undergo surgery at the NIH Clinical Center in a 30-minute operation to place the implant in one eye. The surgery is done under local anesthetic. Before the procedure, patients are given a steroid injection along side the eye to minimize inflammation after surgery. Following the procedure, patients return for follow-up visits once a month for 6 months. At these visits, several of the exams described above are repeated to evaluate treatment effects and check for adverse side effects. After 6 months, the implant is surgically removed. Post-surgical care for both implant and explant surgeries include examinations the day and week after surgery to examine the wound, a high dose of steroid immediately after surgery, oral antibiotics for 7 days, and eye drops for 1 week to prevent infection and inflammation. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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