NCT02414516

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

4.3 years

First QC Date

March 23, 2015

Last Update Submit

March 11, 2019

Conditions

Solid Tumor

Keywords

HDACEpigeneticHistoneAcetylation

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    6 weeks

Secondary Outcomes (3)

  • Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2

    4 weeks

  • Objective Response (OR)

    22 weeks

  • Durability of Objective Response (DOR)

    22 weeks

Study Arms (1)

OBP-801

EXPERIMENTAL
Drug: OBP-801

Interventions

OBP-801DRUG

OBP-801 will be administered IV

OBP-801

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Publications (1)

  • 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.

    PMID: 34613570DERIVED

MeSH Terms

Interventions

YM753 compound

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

April 10, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2019

Study Completion

August 1, 2019

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

US(1)