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Carcinoma, Non-Small-Cell LungPhase 1/2NCT00522938

Clinical Trial of the Safety and Effectiveness of CHR-2797 With Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

A Phase 1/2 study testing CHR-2797 (tosedostat) and erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Chroma Therapeutics at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is an open-label, multicenter, multiple-dose, Phase I-II study of CHR-2797 co-administered with erlotinib in patients with histologically or pathologically confirmed Stage IIIB (with pleural effusion), Stage IV, or recurrent metastatic NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
CHR-2797 (tosedostat) and erlotinib
Type of treatment
Pill or oral medicine
How many people
2 participants
Where
7 sitesUnited States
Study dates
Dec 2007to Apr 2008
Phase
Phase 1/2
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

  • Histologically and/or pathologically confirmed NSCLC (cytologic specimens obtained by brushing, washing, or needle aspiration of a defined lesion are acceptable). This includes the histologic subtypes of squamous cell, adeno, large cell, anaplastic cell, bronchioalveolar carcinoma, and NSCLC not otherwise specified (NOS). Note that tumors with the presence of small cell anaplastic elements are not eligible
  • NSCLC with documentation of Stage IIIB (with pleural effusion), or Stage IV, or recurrent metastatic disease based on current TNM classification
  • Disease progression or relapse following failure of platinum-based chemotherapy
  • For Study Phase A, patients are not required to have measurable disease (according to RECIST criteria) for enrollment. For patients in Study Phase B, patients must have measurable disease according to RECIST, defined by at least 1 lesion that can be accurately measured. All other lesions (e.g., pleural effusions) including small lesions (<1 cm×1 cm by spiral CT scan) are considered non-measurable for the purposes of this study. Baseline tumor measurements are to be completed as close as possible to, but no longer than 14 days before the start of study treatment
  • Prior radiation to the measurable site(s) of disease is not allowed, unless disease progression has been documented at that site since the radiotherapy. Patients who have had extensive radiotherapy are also excluded, because of the associated myelosuppressive effect
  • Prior surgery is allowed, provided it was completed at least 4 weeks prior to enrollment and the patient has recovered from surgery.
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  • No known prior primary brain, metastatic brain, or meningeal tumors or clinical signs or symptoms of brain metastases
  • Able to understand and willing to sign an informed consent document
  • Age ≥18 years
  • Predicted life expectancy >3 months
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
  • Laboratory values within the normal or reasonable ranges and, specifically,adequate bone marrow, hepatic, and renal function including the following:
  • Hemoglobin >10 g/dL, absolute neutrophil count (ANC)>1.5×109/L, platelets ≥100×109/L
  • Total bilirubin ≤1.5× upper limit normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5×ULN or <5×ULN in patients with documented liver metastases
  • Creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min
  • Female patients with reproductive potential must have a negative serum pregnancy test within 72 hours prior to start of study medication. All female patients of childbearing potential, and all male patients, must agree to use a medically acceptable method of contraception or agree to be abstinent throughout the treatment period and for 3 months after discontinuation of treatment. (See Section 4.1for more information.)
  • Screening for LVEF >= 55%

Who cannot join

  • Excluded therapies:
  • Concurrent anti-cancer therapy
  • Treatment with cytotoxic agents within the last 3 or 4 weeks, depending on the usual frequency of administration of the regimen, or within the last 6 weeks for agents such as mitomycin. Patients must have had resolution of acute treatment-related toxicities to baseline or National Cancer Institute Common Toxicity Criteria (NCI-CTC) Grade <1, with the exception of alopecia
  • Therapy within the last 28 days or while on study with another investigational drug
  • Use of biological response modifiers, such as granulocyte-colony stimulating factor (G-CSF) or erythropoietin, within 28 days of enrollment
  • Prior therapy with an epidermal growth factor receptor (EGFR) inhibitor
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  • Radiation to the site(s) of measurable disease, unless disease progression has been documented at that site since the radiotherapy.
  • Need for palliative radiotherapy of indicator lesions
  • Treatment with known strong CYP3A4 inhibitors, for example '- azole antifungals, protease inhibitors, erythromycin, clarithromycin within 2 weeks of enrollment or at any time during the study
  • Treatment with strong CYP3A4 inducers such as rifampicin, rifabutin or rifapentine within 2 weeks of enrollment or at any time during the study
  • Warfarin or doses of coumadin (or equivalent) that are higher than 1mg/day
  • Excluded medical conditions:
  • Current hematological malignancy
  • Gastro-intestinal abnormalities including:
  • Inability to take oral medication
  • Requirement for intravenous (IV) alimentation
  • Malabsorption syndrome
  • Active peptic ulcer disease
  • A serious uncontrolled medical disorder or active infection which would impair their ability to receive study treatment
  • Known primary brain, metastatic brain, or meningeal tumors, or clinical signs or symptoms of brain metastases
  • Second malignancy (except adequately treated basal cell carcinoma of the skin or in-situ carcinoma of the cervix or breast)
  • Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
  • Uncontrolled hypercalcemia (>NCI-CTC Grade 1)
  • Significant cardiovascular disease including but not limited to the following:
  • History (past or present) of congestive heart failure
  • History (past or present) of angina pectoris requiring medication
  • History of myocardial infarction with past 12 months
  • Presence of clinically significant valvular heart disease
  • History (past or present) of arrhythmia requiring treatment
  • Presence of conduction defect on Screening ECG
  • History (past or present) of uncontrolled hypertension
  • Patients with interstitial lung disease
  • Major surgery within 4 weeks prior to enrollment
  • >20% weight loss in previous 3 months
  • Pregnant or lactating women
  • Known rapidly deteriorating liver function tests (2×ULN rise in 1 week)
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and/or compliance with the requirements of the protocol
  • Known or suspected allergy to any study medication used in this study

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90210

  • Clinworks Research Center

    Charlotte, North Carolina, 28207

  • Carolina BioOncology Institute

    Huntersville, North Carolina, 28070

  • Medical Oncology Care Associates

    Orange, California, 92868

  • Oncology Associates of West Kentucky

    Paducah, Kentucky, 42003

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

About this study

Official title: A Phase I-II, Multicenter, Open-label Trial of Co-administered CHR-2797 and Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

This is an open-label, multicenter, multiple-dose, Phase I-II study of CHR-2797 co-administered with erlotinib in patients with histologically or pathologically confirmed Stage IIIB (with pleural effusion), Stage IV, or recurrent metastatic NSCLC. Throughout this protocol, "study medication" includes both CHR-2797 and erlotinib.

This study will involve 2 distinct study phases. Study Phase A will assess safety and determine the MTD of the combination of CHR-2797 and erlotinib. In addition, PK profiles for the combination of CHR-2797 and erlotinib will be evaluated. In Study Phase B, the dose chosen based on the maximum tolerated dose established in Study Phase A will be administered in a single-arm treatment design in order to evaluate the efficacy of co-administration of CHR-2797 and erlotinib.

Read the detailed description

Study Phase A:

Maximum tolerated dose will be determined during Cycle 1. Tumor assessments will be made after Cycle 2 (56 days), although it is not mandatory for Phase A patients to have measurable disease. Patients who have satisfactory outcomes after Cycle 2 may continue treatment for up to a year with erlotinib 150 mg/day, and the dose of CHR-2797 they received in Study Phase A.

Study Phase B:

Patients will be treated with the dose of CHR-2797 selected in Study Phase A and 150mg/day erlotinib. Patients will receive 2 cycles of treatment (56 days) before efficacy assessment. Patients who have complete response, partial response, or stable disease are eligible to continue the study for up to a year until disease progression or unacceptable toxicity. If a patient has complete response, partial response, or stable disease at the end of the 1-year study period and the Investigator believes that continuation treatment would be beneficial, the patient may continue to be treated at the dose of CHR-2797 under a separate protocol.

Being tested
CHR-2797 (tosedostat), erlotinib
Keywords
Lung, Cancer, Non-small, Lung Cancer, NSCLC, erlotinib, oral, Locally Advanced Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms, Lung Neoplasms

What participants receive

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

  • CHR-2797 (tosedostat)Drug

    Once daily, oral ingestion of CHR-2797 capsules(PhaseI: 120mg, 160mg or 200mg depending on cohort or Phase II: recommended dose) capsules until progressive disease or withdrawal from the study

  • erlotinibDrug

    Also called Tarceva

    Once daily, oral ingestion of erlotinib tablets 150mg tablets until progressive disease or withdrawal from the study. Per protocol, the Investigator may reduce the dose of erlotinib or cease treatment with erlotinib(per label) with Sponsor approval.

What is being measured

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

  1. Study Phase A- To determine the safety, tolerability, and maximum tolerated dose (MTD) of CHR-2797 when co-administered with erlotinib

    Measured: end of study

  2. Study Phase B- To determine the objective tumor response rate to CHR-2797 and erlotinib when co-administered to patients with histologically and/or pathologically confirmed Stage IIIB, Stage IV, or recurrent metastatic non-small cell lung cancer (NSCLC)

    Measured: End of study

Secondary outcomes (3)

  1. Study Phase A- To determine the pharmacokinetic (PK) profiles of CHR-2797 and erlotinib when co-administered

    Measured: End of study

  2. Study Phase B- To further evaluate the efficacy of the combination of CHR-2797 and erlotinib in patients with locally advanced or metastatic non small cell lung cancer (NSCLC)

    Measured: End of study

  3. Study Phase B- To determine the safety and tolerability of CHR-2797 and erlotinib when co administered. To determine the trough levels of CHR-2797 and erlotinib after co-administration for 28 days

    Measured: End of study

Timeline

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

  1. First posted30 Aug 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionFeb 2008
  4. Study completionApr 2008

Why it stopped: Very poor recruitment of patients to the study

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 1/2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522938
Sponsor's protocol ID
CHR-2797-005
Status last verified
Feb 2012
First submitted
29 Aug 2007
Last updated
28 Jun 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CHR-2797 (tosedostat) and erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Chroma Therapeutics at 7 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 18 inclusion and 38 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: stopped early, as of the sponsor's last update on 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Very poor recruitment of patients to the study). Results are not available in the source record.

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?

Study Phase A- To determine the safety, tolerability, and maximum tolerated dose (MTD) of CHR-2797 when co-administered with erlotinib (time frame: end of study). The study lists 2 primary outcomes in all. 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 NCT00522938.

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 28 Jun 2012.

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