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Solid TumorsPhase 1NCT01277146

A Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors

A Phase 1 study testing OMP-59R5 in people with Solid Tumors, run by OncoMed Pharmaceuticals, Inc. at 2 sites 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

This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously treated solid tumors for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Solid Tumors
What is being tested?
OMP-59R5
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
2 sitesUnited States
Study dates
Dec 2010to May 2013
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have a histologically confirmed malignancy that is metastatic or unresectable for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT or MRI.
  • Subjects must have received their last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to enrollment, 6 weeks if the last regimen included BCNU or mitomycin C.
  • Age >18 years
  • ECOG performance status <2 (see Appendix B)
  • Life expectancy of more than 3 months
  • Subjects must have normal organ and marrow function as defined below:
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  • Absolute neutrophil count >1000/mL
  • Hemoglobin >9.0 g/dL
  • Platelets >100,000/mL
  • Total bilirubin <1.5 X institutional upper limit of normal (ULN)
  • AST (SGOT) and ALT (SGPT) < 3 X institutional ULN (for subjects with hepatic metastases < 5 X institutional ULN)
  • PT and PTT within 1.5 X institutional ULN
  • Creatinine <1.5 X institutional ULN OR
  • Creatinine clearance >60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal
  • Women of childbearing potential must have had a prior hysterectomy or have a negative serum pregnancy test and be using adequate contraception prior to study entry and must agree to use adequate contraception from study entry through at least 6 months after discontinuation of study drug. Men must also agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and from study entry through at least 6 months after discontinuation of study drug. Should a woman enrolled in the study or a female partner of a man enrolled in the study become pregnant or suspect she is pregnant while participating in this study or within 6 months after discontinuation of study, she should inform the Investigator immediately.
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Subjects receiving any other investigational agents
  • Subjects with brain metastases (subjects must have a CT scan or MRI of the head within 28 days prior to enrollment to rule out brain metastases), uncontrolled seizure disorder, or active neurologic disease
  • History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
  • Significant intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women or nursing women
  • Subjects with known HIV infection
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  • Known bleeding disorder or coagulopathy
  • Subjects receiving heparin, warfarin, or other similar anticoagulants, except for subjects on low molecular weight heparin for DVT/PE prophylaxis. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
  • New York Heart Association Classification II, III, or IV
  • Subjects with a blood pressure of >140/90 mmHg. The blood pressure must be taken three times 10 minutes apart. Subjects taking antihypertensive medications must be taking ≤ 2 medications to obtain this level of blood pressure control.
  • Subjects with EKG evidence of ischemia or ≥ Grade 2 ventricular arrhythmia, subjects who have a history of acute myocardial infarction within 6 months, or subjects with unstable angina.
  • Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease.
  • Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease.
  • Subjects with >1 grade 1 diarrhea.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: A Phase 1 Dose Escalation Study of OMP-59R5 in Subjects With Solid Tumors

This is an open-label Phase 1 dose escalation study of OMP-59R5 in subjects with previously treated solid tumors for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit. Up to 44 subjects will be enrolled at up to 2 centers. Subjects will be assessed for safety, immunogenicity, pharmacokinetics, biomarkers, and efficacy. No formal interim analyses will be performed.

Prior to enrollment, subjects will undergo screening to determine study eligibility. Upon enrollment, subjects will receive intravenous (IV) infusions of OMP-59R5 at a assigned dosing schedule for 56 days. After 56 days, subjects will be assessed for disease status. If there is no evidence of disease progression or if the tumor is smaller, then subjects may continue to receive IV infusions of OMP-59R5 every week until disease progression.

Dose escalation will be conducted to determine the maximum tolerated dose (MTD). No dose escalation or reduction will be allowed within a dose cohort. The first 2 subjects enrolled in a cohort will not be treated on the same day. The dose may be administered at any time during the day. Three subjects will be treated at each dose level if no dose-limiting toxicities (DLTs) are observed. The first 2 subjects in each cohort will not be started on OMP-59R5 on the same day. If 1 of 3 subjects experiences a DLT, that dose level will be expanded to 6 subjects. If 2 or more subjects experience a DLT, no further subjects will be dosed at that level and 3 additional subjects will be added to the preceding dose cohort unless 6 subjects have already been treated at that dose level. Subjects will be assessed for DLTs from the time of the first dose through 28 days. Dose escalation for newly enrolled subjects, if appropriate, will occur after all subjects in a cohort have completed their Day 28 DLT assessment. Subjects with stable disease or a response at Day 56 will be allowed to continue to receive weekly doses of OMP-59R5 until disease progression. An additional 14 subjects will be enrolled at the highest dose level that result in <2 of the 6 subjects experiencing a DLT.

Conditions
Solid Tumors
Being tested
OMP-59R5
Keywords
Phase 1, dose escalation, histologically confirmed, malignancy metastatic

What participants receive

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

  • OMP-59R5Drug

    IV infusion

Study groups in NCT01277146
Study groupRoleWhat they receive
OMP-59R5ExperimentalNot described
Receives: Drug: OMP-59R5

What is being measured

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

  1. To determine the safety of OMP-59R5 in subjects with previously treated solid tumors

    The number of patients experiencing Adverse Events will be reported.

    Measured: continuous

Secondary outcomes (3)

  1. To determine the pharmacokinetics of OMP-59R5 in subjects with previously treated solid tumors

    The half-life, volume of distribution, and clearance will be determined

    Measured: First 8 doses and following treatment termination

  2. To determine the immunogenicity of OMP-59R5 in subjects with previously treated solid tumors

    The rate of neutralizing antibodies will be determined

    Measured: continuous

  3. To assess the preliminary efficacy of OMP-59R5 in subjects with previously treated solid tumors

    The response outcome in patient will be determined

    Measured: continuous

Timeline

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

  1. First posted14 Jan 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionMar 2013
  4. Study completionMay 2013

Resources

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
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01277146
Sponsor's protocol ID
59R5-001
Status last verified
Sep 2020
First submitted
6 Jan 2011
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
No

Publications

  • Smith DC, Chugh R, Patnaik A, Papadopoulos KP, Wang M, Kapoun AM, Xu L, Dupont J, Stagg RJ, Tolcher A. A phase 1 dose escalation and expansion study of Tarextumab (OMP-59R5) in patients with solid tumors. Invest New Drugs. 2019 Aug;37(4):722-730. doi: 10.1007/s10637-018-0714-6. Epub 2018 Dec 28.

    PubMed 30591982

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OMP-59R5 in people with Solid Tumors, run by OncoMed Pharmaceuticals, Inc. at 2 sites 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 16 inclusion and 14 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

To determine the safety of OMP-59R5 in subjects with previously treated solid tumors (time frame: continuous). 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 NCT01277146, which also lists 1 linked publication.

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 9 Sep 2020.

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