A Dose-Escalation Study of OBP-801 in Patients With Advan... | NCT02414516

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

NCT02414516

Sponsor

Oncolys BioPharma Inc

Status

Unknown status

Last Update Posted

Mar 13, 2019Actual

Enrollment

17Actual

Phase

Phase 1

Conditions

Solid Tumor

Interventions

OBP-801

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jun 2019Estimated

Completion Date

Aug 2019Estimated

First Submitted Date

Mar 23, 2015

First Submission Date that Met QC Criteria

Apr 9, 2015

First Posted Date

Apr 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Label	Type	Description	Intervention Names
OBP-801	Experimental		Drug: OBP-801

Name	Type	Description	Arm Group Labels	Other Names
OBP-801	Drug	OBP-801 will be administered IV	OBP-801

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Tolerated Dose		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2		4 weeks
Objective Response (OR)		22 weeks
Durability of Objective Response (DOR)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barbara Ann Karmanos Cancer Institute		Detroit	Michigan	48201-1379	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34613570	Derived	Heath EI, Weise A, Vaishampayan U, Danforth D, Ungerleider RS, Urata Y. Phase Ia dose escalation study of OBP-801, a cyclic depsipeptide class I histone deacetylase inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2022 Apr;40(2):300-307. doi: 10.1007/s10637-021-01180-9. Epub 2021 Oct 6.