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A Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02414516
Recruitment Status : Active, not recruiting
First Posted : April 10, 2015
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Oncolys BioPharma Inc

Brief Summary:
This Phase 1a, single center, open-label, repeat dose study will evaluate the safety, efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: OBP-801 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors
Study Start Date : March 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: OBP-801 Drug: OBP-801
OBP-801 will be administered IV




Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2 [ Time Frame: 4 weeks ]
  2. Objective Response (OR) [ Time Frame: 22 weeks ]
  3. Durability of Objective Response (DOR) [ Time Frame: 22 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patient Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

  • Histologically or cytologically confirmed metastatic or unresectable solid tumor.
  • Has failed treatment with all standard therapies for their malignancy.
  • Adequate Karnofsky Performance Status.
  • An expected survival of at least 3 months.
  • Adequate organ and bone marrow function.
  • Signed informed consent form for study participation prior to screening.

Patient Exclusion Criteria

Patients presenting with any of the following will be excluded in the study:

  • Clinically significant disease as defined by the protocol.
  • Surgical therapy or other therapies within period as defined by the protocol.
  • Any condition that will interfere with compliance with the protocol as determined by investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414516


Locations
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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Oncolys BioPharma Inc
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Responsible Party: Oncolys BioPharma Inc
ClinicalTrials.gov Identifier: NCT02414516    
Other Study ID Numbers: OBP-801-001
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by Oncolys BioPharma Inc:
HDAC
Epigenetic
Histone
Acetylation
Additional relevant MeSH terms:
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Neoplasms