Clinical trials: Induction Chemotherapy
Chemotherapy-induced Nausea and Vomiting
A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC
The primary study objective is to demonstrate the superiority of APF530 500 mg given subcutaneously (SC) compared with ondansetron 0.15 mg/kg given intravenously (IV) (up to a maximum of 16 mg) in the delayed-phase (> 24-120…
- Trial name
- NCT02106494
- Testing
- APF530, Ondansetron, Fosaprepitant
- Where
- 7 sites in United States
- Volunteers
- 942 people
- Sponsor
- Heron Therapeutics
Chemotherapy-induced Peripheral Neuropathy (CIPN)
AK135 in Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of AK135 for the treatment of chemotherapy-induced peripheral neuropathy in patients with…
- Trial name
- NCT06860789
- Testing
- AK135
- Where
- 2 sites in China
- Volunteers
- 85 people
- Sponsor
- Akeso
Breast Cancer Female
Nanogen Pegcyte Clinical Study for the Prevention of CIN in Breast-cancer Patients.
Accelerated AC regimen-Doxorubicin 60 mg/m2,Cyclophosphamide 600 mg/m2 on day 1 \& day 14 of each cycle along with G-CSF support for up to 4 cycles, followed by Paclitaxel 175 mg/m2 in the next 4 cycles is the standard clinical…
- Trial name
- NCT03381417
- Testing
- pegcyte, Neulastim
- Where
- Vietnam
- Volunteers
- 128 people
- Sponsor
- Nanogen Pharmaceutical Biotechnology Joint Stock Company
Adult Acute Lymphoblastic Leukemia
Phase III Study of Vincristine Sulfate Liposome For Injection In Adults With Naïve Acute Lymphoblastic Leukemia
The purpose of this study is to determine whether vincristine sulfate liposome could reduce less peripheral neuropathy than vincristine sulfate,and be as effective as vincristine sulfate in adults with Naïve Acute Lymphoblastic…
- Trial name
- LY01609 (NCT02072785)
- Testing
- Vincristine Sulfate Liposome, Vincristine Sulfate
- Where
- China
- Volunteers
- 480 people
- Sponsor
- Nanjing Luye Sike Pharmaceutical Co., Ltd.
Radiation Induced Oral Mucositis
A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and severity of radiation induced oral mucositis in…
- Trial name
- NCT02508389
- Testing
- Low Dose GC4419: 30mg/day, High Dose GC4419: 90mg/day, Intensity-Modulated Radiation Therapy
- Where
- 64 sites in United States, Canada and 1 more
- Volunteers
- 223 people
- Sponsor
- Galera Therapeutics, Inc.
Myeloid Leukemia
Trial Comparing Pegfilgrastim With Filgrastim as an Adjunct to Chemotherapy for Acute Myeloid Leukaemia (AML)
The purpose of this study is to determine if a single dose of pegfilgrastim is able to reduce the time of severe neutropenia in patients receiving induction and consolidation myelosuppressive chemotherapy for de novo acute…
- Trial name
- NCT00114764
- Testing
- filgrastim, pegfilgrastim
- Volunteers
- 84 people
- Sponsor
- Amgen
Colorectal Cancer, Chemotherapy-induced Peripheral Neuropathy
Preventive Treatment of Oxaliplatin Induced Peripheral Neuropathy in Metastatic Colorectal Cancer (POLAR-M)
This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.
- Trial name
- POLAR-M (NCT03654729)
- Testing
- Calmangafodipir (2 µmol/kg), Calmangafodipir (5 µmol/kg)
- Where
- 98 sites in United States, Belgium and 11 more
- Volunteers
- 291 people
- Sponsor
- Egetis Therapeutics AB (publ)
HIV Infections
Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).
- Trial name
- NCT00011895
- Testing
- Abacavir sulfate, Lamivudine and Zidovudine, Efavirenz
- Where
- 42 sites in United States
- Volunteers
- 400 people
- Sponsor
- GlaxoSmithKline
Febrile Neutropenia, Cancer
Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor
This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for…
- Conditions
- Febrile Neutropenia, Cancer, Breast Cancer, Ovarian Cancer
- Trial name
- Monitor-GCSF (NCT01459653)
- Where
- 117 sites in Austria, Belgium and 10 more
- Volunteers
- 1,496 people
- Sponsor
- Sandoz
Malignant Tumor
ONO-7436 Phase II Study in Japan
The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor
- Trial name
- NCT00212602
- Testing
- ONO-7436
- Where
- 9 sites in Japan
- Volunteers
- 420 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Chemotherapy-induced Anemia, Non-myeloid Malignancies
Study of SSS06 for Chemotherapy-Induced Anemia in Non-Myeloid Malignancies
This study employs a multicenter, randomized, open-label, positive drug-controlled, multiple ascending dose clinical trial design to comprehensively evaluate the safety, tolerability, immunogenicity, and pharmacokinetic…
- Trial name
- NCT06854276
- Testing
- SSS06, rhEPO
- Volunteers
- 80 people
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
Peripheral Sensory Neuropathy
Clinical Study on Acetyl-L-Carnitine
Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse drug reaction, and the primary manifestations are different degree of neuromotor, sensorineural and autonomic nervous dysfunction.
- Trial name
- NCT01526564
- Testing
- Acetylcarnitine
- Volunteers
- 239 people
- Sponsor
- Lee's Pharmaceutical Limited
Chemotherapy-Induced Nausea and Vomiting (CINV)
QLM2010 Comparative Pharmacokinetic Study With 2-Minute Intravenous Administration
This is a single-center, single-dose, randomized, open-label, crossover study. Forty-two healthy male and female participants will be enrolled.
- Trial name
- NCT07817004
- Testing
- apripitant and palonosetron injectable emulsion, palonosetron hydrochloride injection, apripitant injection (CINVANTI)
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical (Hainan) Co., Ltd.
Myelodysplastic Syndromes (MDS)
A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS
Alvocidib, a cyclin-dependent kinase 9 (CDK 9) inhibitor, in time-sequential therapy demonstrated significant clinical activity in secondary AML patients with prior MDS.
- Trial name
- NCT03593915
- Testing
- Alvocidib Plus Decitabine (during dose escalation only) or Azacitidine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sumitomo Pharma America, Inc.
Anemia, Non-Myeloid Malignancies
Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
The purpose of this study is to compare the effect of darbepoetin alfa against placebo for the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy.
- Trial name
- NCT00110955
- Testing
- Darbepoetin alfa
- Volunteers
- 391 people
- Sponsor
- Amgen
Solid Tumors, Malignant Hemopathy
Nivestim® (Filgrastim) Tolerance in Patients Treated by Toxic Chemotherapeutic Agents
The main aim of the study is to assess the safety of Nivestim® treatment in patients treated with neutropenia-inducing chemotherapy for a malignant disease, solid tumor or a malignant hemopathy.
- Conditions
- Solid Tumors, Malignant Hemopathy, Chemotherapy-induced Febrile Neutropenia (FN)
- Trial name
- NCT01574235
- Testing
- Nivestim®
- Where
- 87 sites in France
- Volunteers
- 2,114 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Chemotherapy-induced Anemia, Non-Myeloid Malignancy
HEC53856 Tablets for Chemotherapy-induced Anemia in Non-myeloid Malignancies
A Phase II clinical trial to evaluate the efficacy and safety of different dosing regimens of HEC53856 tablets compared to rHuEPO injection in participants of the CIA trial.
- Trial name
- NCT07891377
- Testing
- HEC53856 tablet, rHuEPO injection
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Fatigue Related to Cancer Treatment, Breast Cancer
Nuvastatic® Phase III Trial for Fatigue in Triple-Negative Breast Cancer
The goal of this clinical trial is to evaluate whether Nuvastatic 300 mg capsules can reduce cancer-related fatigue in adult patients with colon cancer undergoing first-line chemotherapy.
- Trial name
- NuvastaticTM (NCT07669467)
- Testing
- Nuvastatic 300
- Where
- 6 sites in India
- Volunteers
- 250 people
- Sponsor
- Natureceuticals Sdn Bhd
Neuropathic Pain, Distal Sensory Polyneuropathy
Effects of LY3848575 Versus Placebo in Participants With Painful Distal Sensory Polyneuropathy
The purpose of this study is to evaluate how safe and how well a treatment works compared to placebo for people with nerve pain that begins in their feet and moves up the leg to just below the knee.
- Trial name
- NCT06568042
- Testing
- LY3848575
- Where
- 76 sites in United States, Canada and 5 more
- Volunteers
- 558 people
- Sponsor
- Eli Lilly and Company
Chemotherapy-induced Nausea and Vomiting
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC.
- Trial name
- HEC (NCT01500213)
- Testing
- Rolapitant, Granisetron, Dexamethasone
- Where
- United States
- Volunteers
- 555 people
- Sponsor
- Tesaro, Inc.