Clinical Trials Logo

Clinical Trial Summary

This study will investigate the safety of the drug ON 123300 at increasing doses to determine the best dose to use in future clinical trials.


Clinical Trial Description

After being informed about the study including potential risks, patients giving written informed consent will proceed to a screening period when assessments will be performed to determine whether the patient is eligible to participate in the study. If the patient is eligible, they will start to receive ON 123300 as capsules every day. On day 1 and Day 8 of the study, patients will be required to provide eight blood samples to allow measurement of the amount of drug in their blood. Three ECGs will also be performed during this time. Patients will continue to receive ON 123300 until disease progression, unacceptable toxicity, or patient or physician decision to stop. The first group of patients will receive 40mg of ON 123300 daily, the next group 80mg of ON 123300, the 120mg, etc. until the correct dose has been determined for future studies. Patients will visit the clinic on Days 1, 2, 8, and 9, then weekly for the first month, then every two weeks for two more months, then every month. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04739293
Study type Interventional
Source Onconova Therapeutics, Inc.
Contact
Status Recruiting
Phase Phase 1
Start date May 13, 2021
Completion date October 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06404528 - Low-dose Chemotherapy Under Hypoglycaemia for the Treatment of Relapsed Refractory Advanced Solid Tumours N/A
Terminated NCT04467853 - A Clinical Study to Evaluate CAR-T Cell-based Medicinal Product in the Treatment of Advanced Solid Tumors Phase 1
Terminated NCT05698888 - Study of VP301 in Patients With Multiple Myeloma, Lymphoma, or Solid Tumors Phase 1
Recruiting NCT04587479 - A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors Phase 1
Withdrawn NCT05472220 - Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma Phase 1
Recruiting NCT05354323 - NECVAX-NEO1 in Addition to Checkpoint Inhibitor in Patients With Solid Tumors Phase 1
Recruiting NCT05430373 - GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors Phase 1
Not yet recruiting NCT05747339 - A Clinical Study on the Efficacy and Mechanism of Tumor Treatment Vaccine (TTV) for Recurrent and Refractory Advanced Solid Tumors N/A
Recruiting NCT05887492 - Study of TNG260 and an Anti-PD Antibody in STK11 Mutated Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05228015 - Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects With Advanced Solid Tumors Phase 1
Active, not recruiting NCT05018273 - Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors Phase 1
Recruiting NCT04621435 - Imaging of Solid Tumors Using FAP-2286 Phase 1
Recruiting NCT05861895 - A Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HF158K1 in Participants With HER-2 Positive or HER-2 Low Expression Advanced Solid Tumors Phase 1
Recruiting NCT06088472 - TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors Early Phase 1
Recruiting NCT05768139 - First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors Phase 1/Phase 2