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Advanced CancerPhase 1/2NCT00408226

Safety Study of MKC-1 Combined With Pemetrexed to Treat Advanced Cancer and Non-Small Cell Lung Cancer

A Phase 1/2 study testing MKC-1 and pemetrexed in people with Advanced Cancer and Non-Small Cell Lung Cancer, run by CASI pharmaceuticals, Inc. at 4 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

To determine the toxicities, maximum tolerated dose (MTD) and recommended phase 2 dose of MKC-1 when administered orally, twice daily for 14 days followed by 7 days without dosing, in combination with pemetrexed (delivered at its recommended single agent dose) to patients with advanced solid tumor malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer, Non-Small Cell Lung Cancer
What is being tested?
MKC-1 and pemetrexed
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
4 sitesUnited States
Study dates
Oct 2006to Jan 2012
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

  • Patients must satisfy this criteria based on the portion of the study for which they are being considered for enrollment:
  • Dose Escalating Phase: Patients with advanced solid tumor malignancies for whom single-agent pemetrexed therapy would not be contraindicated. Measurable disease not required.
  • Phase 2 portion: Current diagnosis of Stage IIIb (due to malignant pleural effusion or supraclavicular lymph node involvement only) or Stage IV histologically and/or cytologically proven non-small cell lung cancer according to staging system of the American Joint Committee on Cancer.
  • Patient has received maximally feasible surgical resection and/or radiotherapy for initial disease.
  • Either disease progression following treatment with one prior chemotherapy regimen used for the treatment of metastatic disease or disease progression following adjuvant/neoadjuvant therapy within one year of last dose of chemotherapy or (for those patients with disease progression following adjuvant/neoadjuvant therapy >1 year of last dose of chemotherapy) disease progression following one additional chemotherapy regimen for metastatic disease.
  • Radiographic or physical examination evidence of at least one site of unidimensionally-measurable disease, using the RECIST criteria with disease assessed within 28 days prior to treatment initiation.
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  • Age ≥ 18 years.
  • ECOG performance status of 0 or 1.
  • All acute toxicity of any prior chemotherapy, surgery or radiotherapy must have resolved to NCI CTCAE Grade ≤ 1, except for alopecia.
  • The following laboratory results, within 10 days of MKC-1 administration:
  • Hemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 75 x 109/L Serum creatinine ≤ 1.5 x ULN (upper limit of normal) Creatinine clearance ≥ 45 mL/min AST ≤ 2.5 x ULN Serum albumin ≥ LLN (lower limit of normal) or 3.5 g/dL Total bilirubin ≤ ULN
  • Signed informed consent.

Who cannot join

  • Pre-existing hepatomegaly with disease measured as ≥ 2 cm below the costal margin, secondary to malignancy.
  • Uncontrolled pleural effusions (defined as more than 2 pleuracenteses within 4 weeks of the first dose of study drug)
  • Administration of cancer-specific therapy within the following periods prior to study drug initiation:
  • less than 4 weeks prior: major surgery (this does not include placement of venous access device or biopsy) or any investigational therapy;
  • less than 3 weeks prior: radiation therapy or chemotherapy (except for oral EGF-R receptor tyrosine kinase inhibitor(s);
  • less than 2 weeks prior: oral EGF-R receptor tyrosine kinase inhibitor(s).
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  • Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use a physical method of contraception. Female patient with childbearing potential must have a negative pregnancy test within the 10 days before the first MKC-1 administration. Male patients must be surgically sterile or agree to use an acceptable method of contraception.
  • Known CNS or leptomeningeal metastases unless treated, clinically stable and not requiring steroids.
  • Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy.
  • Uncontrolled hypercalcemia (serum calcium-corrected > 12 mg/dL)
  • Serious cardiac condition (Class III/IV congestive heart failure according to New York Heart Association classification); documented acute myocardial infarction within the previous 6 months.
  • Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, infection requiring parenteral or oral anti-infective treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.
  • Patients with active secondary malignancies.
  • Treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir and saquinavir).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Swedish Cancer Institute

    Seattle, Washington, 98122

Other trials in United States

About this study

Official title: Phase 1/2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 3 Weeks in Combination With Pemetrexed

To determine the toxicities, maximum tolerated dose (MTD) and recommended phase 2 dose of MKC-1 when administered orally, twice daily for 14 days followed by 7 days without dosing, in combination with pemetrexed (delivered at its recommended single agent dose) to patients with advanced solid tumor malignancies. Also, to determine the antitumor activity, based on the objective response rate and median Progression Free Survival ("PFS"), of oral MKC-1, administered on this schedule in combination with pemetrexed to patients with non small cell lung cancer (NSCLC).

Being tested
MKC-1, pemetrexed
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • MKC-1Drug

    capsules, twice daily for 14 days in 21 day cycle

  • pemetrexedDrug

    standard dosing of 500 mg/m2 infused every 21 days

Study groups in NCT00408226
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: MKC-1; Drug: pemetrexed

What is being measured

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

  1. Occurrence of treatment emergent AEs

    Measured: throughout study participation

Timeline

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

  1. First posted6 Dec 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJun 2009
  4. Study completionJan 2012

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
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00408226
Sponsor's protocol ID
MKC-102
Status last verified
Jan 2012
First submitted
5 Dec 2006
Last updated
20 Jan 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MKC-1 and pemetrexed in people with Advanced Cancer and Non-Small Cell Lung Cancer, run by CASI pharmaceuticals, Inc. at 4 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 12 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 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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?

Occurrence of treatment emergent AEs (time frame: throughout study participation). 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 NCT00408226.

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 20 Jan 2012.

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