Solid TumorsPhase 1NCT01922752

To Determine the Maximum Tolerated Dose of Oral CEP-37440 in Patients With Advanced or Metastatic Solid Tumors

A Phase 1 study testing CEP-37440 in people with Solid Tumors, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 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

The primary objective is to determine the maximum tolerated dose (MTD), safety, and tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumors
What is being tested?: CEP-37440
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 3 sitesUnited States
Study dates: Jul 2013to Dec 2015
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

Patients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy.
Patients must have evidence of recurrent, locally advanced, or metastatic disease.
Patients can either have had no prior anticancer therapy, multiple lines of either prior chemotherapy/biologic therapy/experimental therapy or, if the patient has anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), prior crizotinib.
Patients must have a predicted life expectancy of more than 3 months.
Patients must have presence of at least 1 lesion that is measurable or evaluable using RECIST v1.1.
Patients must have an ECOG performance score of 0, 1, or 2.

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Patients with central nervous system (CNS) metastases will be allowed on this study. Patients may have received surgical and/or radiation treatment. The metastases must be neurologically stable, on or off corticosteroids. Patients can have low level, asymptomatic brain lesions that do not require surgical/radiation intervention acutely. Patients with symptomatic lesions with impending neurologic compromise should be appropriately treated with high dose steroids/radiation and may be re-evaluated for this study when neurologically stable.
Patients must have completed any prior anticancer treatment and must have recovered from any acute toxicities. The period between the last dose of prior treatment and the first dose of study drug treatment must be at least 1 week for radiotherapy and at least 2 to 3 weeks for all other modalities of therapy including chemotherapy, monoclonal antibody therapy, immunotherapy, other investigational drugs, or other kinase inhibitors.
Other criteria apply.

Who cannot join

The patient has ongoing or active infection requiring parenteral antibiotics.
The patient has uncontrolled hypertension despite adequate therapy (ie, systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
The patient has uncontrolled diabetes mellitus (despite therapeutic intervention) and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
The patient has an active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers for which they are treated with curative intent, and no known active disease in the 3 years prior to enrollment.
The patient has a primary brain tumor. Patients may have brain metastases from another primary site.
The patient has QTcF interval greater than 450 msec, has a known history of QTcF prolongation, is taking medications known to prolong QTcF, or has a history of torsade de pointes.
The patient has a prior ALK-inhibitor-related toxicity or any other prior therapy-related acute toxicity that has not resolved prior to the first dose of study drug.
Other criteria apply.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Teva Investigational Site 10689
Chicago, Illinois
Teva Investigational Site 10687
Philadelphia, Pennsylvania
Teva Investigational Site 10686
San Antonio, Texas

Other trials in United States

About this study

Official title: An Open-Label Study to Determine the Maximum Tolerated Dose of Oral CEP-37440 Administered as a Single Agent in Patients With Advanced or Metastatic Solid Tumors

The primary objective is to determine the maximum tolerated dose (MTD), safety, and tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic solid tumors.

Conditions: Solid Tumors
Being tested: CEP-37440
Keywords: CEP-37440, Advanced solid tumors, Metastatic solid tumors

What participants receive

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

CEP-37440Drug
CEP-37440 will be supplied as 25 mg and 100 mg capsules and will be orally administrated daily.
Patients will be enrolled sequentially in dose escalating cohorts to receive CEP-37440 until a maximum tolerated dose has been defined.

Study groups in NCT01922752
Study group	Role	What they receive
CEP-37440	Experimental	Not described Receives: Drug: CEP-37440

What is being measured

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

Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: 8 months

Secondary outcomes (5)

Time to Response (TTR)
The time interval from the date of first dose to the first documented response (complete or partial response)
Measured: 8 months
Number of participants with adverse events
Measured: From signing of the informed consent to the end of the follow-up visit (approximately Month 10)
Time to Progression (TTP)
The time interval from date of first dose to first documented disease progression
Measured: 8 months
Progression-free Survival (PFS)
Time interval from date of first does to first documented disease progression or death from any cause (whichever occurs first)
Measured: 10 months
Time to New Metastases (TTNM)
Time interval from date of first dose to first documented new metastatic lesion not reported at baseline
Measured: 8 months

Timeline

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

Jul 2013Dec 2015

First posted14 Aug 2013 (estimated)
Study startJul 2013
Primary completionSep 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: NCT01922752
Sponsor's protocol ID: C37440/1108
Status last verified: Nov 2021
First submitted: 12 Aug 2013
Last updated: 12 Nov 2021
Results posted: No
Data monitoring committee: No

Publications

Schilder RJ, Rasco D, Sharma MR. An open-label study to determine the maximum tolerated dose of oral ESK-440 administered as a single agent in patients with advanced or metastatic solid tumors. Neoplasia. 2025 Mar;61:101133. doi: 10.1016/j.neo.2025.101133. Epub 2025 Feb 5.
PubMed 39914170

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 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study to Determine the Maximum Tolerated Dose of Oral CEP-37440 Administered as a Single Agent in Patients With Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT01922752
Acronym / sponsor ID: C37440/1108
Conditions: Solid Tumors
Keywords: CEP-37440, Advanced solid tumors, Metastatic solid tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Sep 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 14 Aug 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.

The primary objective is to determine the maximum tolerated dose (MTD), safety, and tolerability of oral CEP-37440 administered daily to patients with advanced or metastatic solid tumors.

Study design

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

Arm	Type	Receives
CEP-37440	Experimental	Drug: CEP-37440

Who may qualify

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

Key inclusion criteria (9 listed)

Patients must have histologic or cytologic evidence of a solid neoplasm for which no standard therapy is available, or have progressed despite standard therapy, or are intolerant to standard therapy.
Patients must have evidence of recurrent, locally advanced, or metastatic disease.
Patients can either have had no prior anticancer therapy, multiple lines of either prior chemotherapy/biologic therapy/experimental therapy or, if the patient has anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), prior crizotinib.
Patients must have a predicted life expectancy of more than 3 months.
Patients must have presence of at least 1 lesion that is measurable or evaluable using RECIST v1.1.

Key exclusion criteria (8 listed)

The patient has ongoing or active infection requiring parenteral antibiotics.
The patient has uncontrolled hypertension despite adequate therapy (ie, systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
The patient has uncontrolled diabetes mellitus (despite therapeutic intervention) and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
The patient has an active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers for which they are treated with curative intent, and no known active disease in the 3 years prior to enrollment.
The patient has a primary brain tumor. Patients may have brain metastases from another primary site.

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
CEP-37440CEP-37440 will be supplied as 25 mg and 100 mg capsules and will be orally administrated daily. Patients will be enrolled sequentially in dose escalating cohorts to receive CEP-37440 until a maximum tolerated dose has been defined.	Drug	CEP-37440

Primary outcome

Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time frame: 8 months

5 secondary outcomes

Time to Response (TTR)
Time frame: 8 months
Number of participants with adverse events
Time frame: From signing of the informed consent to the end of the follow-up visit (approximately Month 10)
Time to Progression (TTP)
Time frame: 8 months
Progression-free Survival (PFS)
Time frame: 10 months
Time to New Metastases (TTNM)
Time frame: 8 months

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 12 Nov 2021.
Derived from this study: PubMed 39914170Schilder RJ, Rasco D, Sharma MR. An open-label study to determine the maximum tolerated dose of oral ESK-440 administered as a single agent in patients with advanced or metastatic solid tumors. Neoplasia. 2025 Mar;61:101133. doi: 10.1016/j.neo.2025.101133. Epub 2025 Feb 5.

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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CEP-37440 in people with Solid Tumors, run by Teva Branded Pharmaceutical Products R&D, Inc. at 3 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 9 inclusion and 8 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (time frame: 8 months). 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 NCT01922752, 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 12 Nov 2021.