Clinical trials

16,304

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Condition / disease
Location
Status: Not yet recruiting

Pirtobrutinib Plus Methotrexate-Based Chemoimmunotherapy for Systemic DLBCL With CNS Involvement

This is an open-label, prospective, single-arm, multicenter study designed to evaluate the efficacy and safety of MTX plus pirtobrutinib combined with routinely-used clinical chemoimmunotherapy regimens in patients with DLBCL and central nervous system (CNS) involvement.

Participants needed: 24
Trial details
Phase: Phase 2Age: 14-80Biological sex: AllType: InterventionalSponsor: Pengpeng XuUpdated: Sep 11, 2026Locations: 1
Eligibility criteria

Bone marrow function: absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; platelet co... [+4]

Contraindication to any drug in the treatment regimen. [+6]

Status: Recruiting

IBI3042 Study in Healthy Participants and Overweight or Obese Participants

This is a Phase 1 study of IBI3042, an investigational oral medicine being developed as a potential treatment for overweight and obesity. The study has two parts. Part A will evaluate single doses of IBI3042 in healthy adults. Part B will evaluate repeated doses for 13 weeks in adults with overweight or obesity. The main goal is to assess the safety and tolerability of IBI3042. The study will also evaluate how IBI3042 is processed in the body and explore its effects on body weight and other metabolic measures. Some participants will receive placebo, and some Part B groups will also receive orforglipron for comparison.

Participants needed: 104
Trial details
Phase: Phase 1Age: 18-55Biological sex: AllType: InterventionalSponsor: Innovent Biologics (Suzhou) Co. Ltd.Updated: Sep 11, 2026Locations: 1
Eligibility criteria

Aged 18 to 55 years, inclusive. [+4]

Known or suspected hypersensitivity to any component of the study drug or to GLP... [+10]

Status: Recruiting

A Phase Ia/Ib Study of HW221043 in Participants With Advanced Solid Tumors

This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HW221043 tablets in participants with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib).

Participants needed: 99
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.Updated: Sep 11, 2026Locations: 1
Eligibility criteria

Men or women ≥18 years old. [+9]

Allergic to HW221043 Tablet or its components. [+19]

Status: Not yet recruiting

Dyclonine vs. Tetracaine for Local Anesthesia in Unsedated Gastroscopy

Gastroscopy is a key diagnostic approach for upper gastrointestinal diseases, but pharyngeal passage of the gastroscopy often causes participants' discomfort. Topical pharyngeal anesthetics are routinely used to alleviate such discomfort. Dyclonine hydrochloride mucilage and tetracaine hydrochloride jelly are the two most commonly used topical pharyngeal anesthetics in clinical practice. Although both agents are widely used, their comparative efficacy in unsedated gastroscopy remains unclear, and high-quality evidence is scarce. This study aims to compare their anesthetic efficacy,participant comfort, and safety.

Participants needed: 208
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: General Hospital of Shenyang Military RegionUpdated: Sep 11, 2026Locations: 1
Eligibility criteria

Age 18-75 years, of either sex; [+4]

Known allergy to the study agents; [+8]

Status: Recruiting

AMAZE 3: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Not Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea

This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with excess body weight and obstructive sleep apnoea not treated with positive airway pressure lose weight and improve sleep apnoea. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.

Participants needed: 300
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Novo Nordisk A/SUpdated: Sep 11, 2026Locations: 80
Eligibility criteria

Male or female (sex at birth) [+2]

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central lab... [+4]

Status: Recruiting

Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma

The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.

Participants needed: 380
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Hoffmann-La RocheUpdated: Sep 11, 2026Locations: 75
Eligibility criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screen... [+4]

Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in ti... [+3]

Status: Recruiting

A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

The purpose of the study is to demonstrate the efficacy, safety and tolerability of rozanolixizumab compared with placebo in the treatment of adult study participants with Ocular Myasthenia Gravis.

Participants needed: 120
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: UCB Biopharma SRLUpdated: Sep 11, 2026Locations: 11
Eligibility criteria

Participant must be a minimum of 18 years of age inclusive at the time of signin... [+11]

Participant has any clinically significant medical or psychiatric condition (inc... [+7]

Status: Recruiting

Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region

This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with Nucleos(t)ide Analogue (NAs).

Participants needed: 84
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: AusperBio Therapeutics Inc.Updated: Sep 11, 2026Locations: 10
Eligibility criteria

Adults ≥18 years of age (or per local age of majority) and ≤65 years of age at S... [+10]

Clinically significant disease other than chronic hepatitis B virus (HBV) infect... [+30]

Status: Recruiting

A Multi-centre Chart Review Study of Stage I-III Non-Small Cell Lung Cancer in China

This chart review study is proposed in China to understand the treatment patterns, biomarker testing, and clinical outcomes with SOC and some selected regimens among patients diagnosed with stage I-III NSCLC.

Participants needed: 3,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: AstraZenecaUpdated: Sep 11, 2026Locations: 1
Eligibility criteria

Stage I-III at initial NSCLC diagnosis [+1]

NSCLC is not the primary cancer diagnosis [+3]

Status: Recruiting

Phase 4 Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Chinese Participants With Generalized Myasthenia Gravis

The purpose of the study is to assess the clinical efficacy of rozanolixizumab in adult Chinese participants with generalized myasthenia gravis (gMG) in the first Treatment Cycle.

Participants needed: 40
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: UCB Biopharma SRLUpdated: Sep 11, 2026Locations: 12
Eligibility criteria

Study participant must be ≥18 years of age at the time of signing the informed c... [+6]

Study participant has a known hypersensitivity to any components of the study dr... [+6]

Status: Recruiting

Safety, Tolerability and Pharmacokinetics of AZD1613 in Adults With Autosomal Dominant Polycystic Kidney Disease

A study to investigate safety, tolerability, and pharmacokinetics of AZD1613 following subcutaneous or intravenous administration in participants with autosomal dominant polycystic kidney disease (ADPKD).

Participants needed: 40
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: AstraZenecaUpdated: Sep 11, 2026Locations: 15
Eligibility criteria

Patients with ADPKD Mayo Class (IB-IE), as per clinical diagnosis (MIC) assessed... [+3]

As judged by the investigator, any evidence of cardiac, vascular, and other rena... [+9]

Status: Recruiting

Durvalumab Consolidation After Chemoradiation Therapy for Limited Stage SCLC in China

This prospective, multicentre, observational study aims to assess the effectiveness and safety of durvalumab as consolidation treatment for patients with LS-SCLC who have not progressed following CRT in real-world setting.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: AstraZenecaUpdated: Sep 11, 2026Locations: 21
Eligibility criteria

Able to provide informed consent [+6]

Patients treated with CRT only without subsequent durvalumab consolidation [+4]

Status: Recruiting

Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma

This study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR.

Participants needed: 18
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Shanghai Exuma Biotechnology Ltd.Updated: Sep 11, 2026Locations: 1
Eligibility criteria

Male or female 18-75 years (inclusive); [+15]

History of receiving allogeneic hematopoietic stem cell transplantation, adoptiv... [+14]

Status: Recruiting

Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET

The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) with high disease burden

Participants needed: 240
Trial details
Phase: Phase 3Age: 12-100Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: Sep 11, 2026Locations: 67
Eligibility criteria

Presence of metastasized or locally advanced, unresectable (curative intent), hi... [+22]

Prior administration of a therapeutic radiopharmaceutical for GEP-NET at any tim... [+9]

Status: Recruiting

A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.

Participants needed: 840
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: AstraZenecaUpdated: Sep 11, 2026Locations: 302
Eligibility criteria

HER2 positive for gastric cancer on a tumor biopsy. [+8]

Lack of physiological integrity of the upper gastrointestinal tract. [+19]

Status: Recruiting

The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer

Introduction: Immunotherapy in combination with chemotherapy have been recommended as the first-line treatment of driver-negative advanced non-small cell lung cancer (NSCLC), but the efficacy is worse in NSCLC patients with bone metastases due to the immunosuppressive microenvironment. Studies have shown that not only the nuclear factor kappa-B ligand (RANKL) inhibitors but also Stereotactic Body Radiation Therapy (SBRT) play a significant role in improving the tumor immune microenvironment. Therefore, narlumosbart,a monoclonal antibody (mAb) targeting RANKL,in combination with SBRT may have synergistic effects and improve efficacy of immunotherapy and chemotherapy in driver-negative advanced NSCLC patients with bone metastases. Methods: This single-arm, single-center phase II clinical trial will enroll NSCLC patients with bone metastases who have not received any systemic therapy. Patients will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg/time, subcutaneous injection, will be administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy/3F is used for spinal metastases, and 30Gy/5F or 35Gy/5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy will be used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include safety and tolerability, progression-free survival, overall survival, bone-related events, pain score, and quality of life. Sample size was calculated using the Simon's Two-Stage method. 9 patients will be enrolled in the first stage. If ≥ 2 patients achieve CR/PR, the second stage of enrollment will be performed. If fewer than 2 patients achieve CR/PR, the trial will be terminated. In the second phase, 15 patients will be enrolled. 27 subjects will be enrolled in this project, considering the dropout rate of 10%. Wangjun Yan AND Zhengfei Zhu are the Co-Principal Investigators of this study.

Participants needed: 27
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: Fudan UniversityUpdated: Sep 11, 2026Locations: 1
Eligibility criteria

Signed informed consent prior to the implementation of any trial-related procedu... [+10]

The pathology is small cell lung cancer (SCLC), including lung cancer mixed with... [+30]

Status: Recruiting

Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors

This is a first-in-human (FIH), Phase 1a/1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced solid tumors.

Participants needed: 153
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: BeOne MedicinesUpdated: Sep 11, 2026Locations: 34
Eligibility criteria

Able to provide a signed and dated written informed consent prior to any study-s... [+5]

Prior severe allergic reactions or hypersensitivity to the active ingredient and... [+6]

Status: Recruiting

Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors

eVOLVE-02 study will evaluate the efficacy and safety of volrustomig as monotherapy or in combination with anti-cancer agents in participants with advanced/metastatic solid tumors.

Participants needed: 257
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: AstraZenecaUpdated: Sep 11, 2026Locations: 98
Eligibility criteria

Age ≥18 at the time of signing the ICF. [+7]

Spinal cord compression. [+19]

Status: Recruiting

Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of surovatamig (AZD0486) monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for LBCL.

Participants needed: 270
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: AstraZenecaUpdated: Sep 11, 2026Locations: 94
Eligibility criteria

Aged 18 years old and above [+9]

Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation [+8]

Status: Recruiting

A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer

This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-3N0-1M0 resectable limited-stage small cell lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the operation was performed 4 weeks after apatinib was discontinued). According to the results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or without radiotherapy was started 4 weeks after surgery. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.

Participants needed: 38
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Jin YingUpdated: Sep 11, 2026Locations: 1
Eligibility criteria

Age between 18 and 75 years old; [+10]

Inability to completely remove all lesions through surgery; [+19]

Status: Recruiting

Phase 2 Study of WGI-0301 for Advanced HCC

The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors.

Participants needed: 60
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Zhejiang Haichang Biotech Co., Ltd.Updated: Sep 11, 2026Locations: 9
Eligibility criteria

≥18 years of age on the day of signing informed consent, male or female. [+21]

Pregnant or breastfeeding patients or expecting to conceive or father children w... [+31]

Status: Recruiting

A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.

Participants needed: 231
Trial details
Phase: Phase 3Age: 5-11Biological sex: AllType: InterventionalSponsor: AstraZenecaUpdated: Sep 11, 2026Locations: 147
Eligibility criteria

Written informed consent from (ICF) at least one parent/caregiver (as per local... [+18]

History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia,... [+4]

Status: Recruiting

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.

Participants needed: 750
Trial details
Phase: Phase 3Age: 18-100Biological sex: AllType: InterventionalSponsor: AmgenUpdated: Sep 11, 2026Locations: 418
Eligibility criteria

Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or a... [+2]

Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell c... [+5]

Status: Recruiting

A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer

Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This "tells" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments. The main aims of the study are: * To check the safety of ASP2138 and how well people can tolerate medical problems during the study. * To find a suitable dose of ASP2138 to be used later in the study. * These are done for ASP2138 given by itself and when given together with the standard cancer treatments. Adults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a "trigger" such as infection, or have a specific heart condition ("New York Heart Association Class III or IV"). Phase 1: Lower to higher doses of ASP2138 * ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection). * Different small groups are given lower to higher doses of ASAP2138. * ASP2138 is either given by itself, or given with 1 of 3 standard treatments: * Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer) * Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer) * ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer) Phase 1b: doses of ASP2138 worked out from Phase 1 * ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1. * People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1. * This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments. * The standard cancer treatments given depends on the type of cancer they have. End of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment. People who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself.

Participants needed: 398
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Astellas Pharma Global Development, Inc.Updated: Sep 11, 2026Locations: 46
Eligibility criteria

Participant is considered an adult according to local regulation at the time of... [+45]

Participant has received other investigational agents, or antineoplastic therapy... [+47]

Status: Recruiting

A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies

This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents

Participants needed: 460
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: AstraZenecaUpdated: Sep 11, 2026Locations: 67
Eligibility criteria

Age ≥ 18 years [+17]

Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treat... [+33]