Solid TumorsPhase 1NCT01910545

Phase 1 Study of OTS167 in Patients With Solid Tumors

A Phase 1 study testing OTS167IV in people with Solid Tumors and Metastatic Tumors, run by OncoTherapy Science, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test the safety and tolerability of an investigational drug called OTS167. OTS167 is a maternal embryonic leucine zipper kinase (MELK) inhibitor which demonstrated antitumor properties in laboratory tests. It is being developed as an anti-cancer drug. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors, Metastatic Tumors
What is being tested?: OTS167IV
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 23 Aug 2013to 4 May 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients, >= 18 years of age at the time of obtaining informed consent.
Patients with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic.
Patients with a malignancy that is either refractory to standard therapy or for which no standard therapy is available.
Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
Patients with measurable or non-measurable disease according to the response evaluation criteria in solid tumors (RECIST , v1.1)
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Patients, both male and female, who are either not of childbearing potential or who agree to use a medically effective method of contraception during the study and for 3 months after the last dose of study drug.
Patients with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol.

Who cannot join

Women who are pregnant or lactating. Women of child-bearing potential (WOCBP), and fertile men with a WOCBP-partner not using adequate birth control.
Patients with known central nervous system (CNS) or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma.
Patients with any of the following hematologic abnormalities at baseline:
Absolute neutrophil count (ANC) < 1,500 per mm3
Platelet count < 100,000 per mm3

Show all 31Show fewer

Patients with any of the following serum chemistry abnormalities at baseline:
Total bilirubin >= 1.5 × the ULN for the institution
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 3 × the upper limit normal (ULN) for the institution (>= 5 × if due to hepatic involvement by tumor)
Serum albumin < 2.5 g/dL
Creatinine >= 1.5 × ULN for the institution (or a calculated creatinine clearance < 60 mL/min/1.73 m2)
Patients with a significant cardiovascular disease or condition, including:
Congestive heart failure (CHF) currently requiring therapy
Need for antiarrhythmic medical therapy for a ventricular arrhythmia
Severe conduction disturbance
Angina pectoris requiring therapy
Corrected QT (QTc) interval > 450 msec (males) or > 470 msec (females)
QTc interval <= 300 msec
History of congenital long QT syndrome or congenital short QT syndrome
Left ventricular ejection fraction < 50%
Uncontrolled hypertension (per the Investigator's discretion)
Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria.
Myocardial infarction (MI) within 6 months prior to first study drug administration
Patients with a known or suspected hypersensitivity to any of the components of OTS167.
Patients with a known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
Patients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 1 week prior to first study drug administration.
Patients with inadequate recovery from acute toxicity associated with any prior antineoplastic therapy.
Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure within 4 weeks prior to first study drug administration.
Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug.
Patients with a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
Patients with the inability or with foreseeable incapacity, in the opinion of the Investigator, to comply with the protocol requirements.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Chicago
Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: PhaseI, Single-Center, Cohort Dose Escalation Trial to Determine the Safety, Tolerance, and Preliminary Antineoplastic Activity of OTS167, a MELK Inhibitor, in Patients With Refractory Locally Advanced or Metastatic Solid Tumor Malignancies

Conditions: Solid Tumors, Metastatic Tumors
Being tested: OTS167IV
Medical subject headings: Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OTS167IVDrug

Study groups in NCT01910545
Study group	Role	What they receive
OTS167IV	Experimental	single arm Receives: Drug: OTS167IV

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients with adverse events and/or dose-limiting toxicities as a measure of safety and tolerability of OTS167 IV infusion.
Measured: Up to 30 days after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 20134 May 2016

First posted29 Jul 2013 (estimated)
Study start23 Aug 2013
Primary completion11 Apr 2016
Study completion4 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01910545
Sponsor's protocol ID: OTS167-FR02
Status last verified: May 2017
First submitted: 23 Jul 2013
Last updated: 1 Jun 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PhaseI, Single-Center, Cohort Dose Escalation Trial to Determine the Safety, Tolerance, and Preliminary Antineoplastic Activity of OTS167, a MELK Inhibitor, in Patients With Refractory Locally Advanced or Metastatic Solid Tumor Malignancies
ClinicalTrials.gov ID: NCT01910545
Acronym / sponsor ID: OTS167-FR02
Conditions: Solid Tumors, Metastatic Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: OncoTherapy Science, Inc.Industry (pharma, biotech, devices)
Study start: 23 Aug 2013
Primary completion: 11 Apr 2016 (actual)
Study completion: 4 May 2016 (actual)
First posted: 29 Jul 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OTS167IV	Experimental	Drug: OTS167IVsingle arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female patients, >= 18 years of age at the time of obtaining informed consent.
Patients with a documented (histologically- or cytologically-proven) solid tumor malignancy that is locally advanced or metastatic.
Patients with a malignancy that is either refractory to standard therapy or for which no standard therapy is available.
Patients with a malignancy that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
Patients with measurable or non-measurable disease according to the response evaluation criteria in solid tumors (RECIST , v1.1)

Key exclusion criteria (31 listed)

Women who are pregnant or lactating. Women of child-bearing potential (WOCBP), and fertile men with a WOCBP-partner not using adequate birth control.
Patients with known central nervous system (CNS) or leptomeningeal metastases not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
Patients with any hematologic malignancy. This includes leukemia (any form), lymphoma, and multiple myeloma.
Patients with any of the following hematologic abnormalities at baseline:
Patients with any of the following serum chemistry abnormalities at baseline:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OTS167IV	Drug	OTS167IV

Primary outcome

Number of patients with adverse events and/or dose-limiting toxicities as a measure of safety and tolerability of OTS167 IV infusion.
Time frame: Up to 30 days after last dose of study drug

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
Individual participant dataSharing planned: No

Related trials for Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OTS167IV in people with Solid Tumors and Metastatic Tumors, run by OncoTherapy Science, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events and/or dose-limiting toxicities as a measure of safety and tolerability of OTS167 IV infusion. (time frame: Up to 30 days after last dose of study drug). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01910545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.