Breast CancerPhase 2NCT00306631
A Study to Determine the Antitumor Activity and Evaluate the Safety of MKC-1
A Phase 2 study testing MKC-1 in people with Breast Cancer, run by CASI pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This phase 2 study will determine the antitumor activity, based on the objective rate, of oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MKC-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Nov 2008
- Phase
- Phase 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 or cytologically confirmed advanced or metastatic adenocarcinoma of the breast
- 18 years or older
- Karnofsky performance status greater than or equal to 70%
- Radiographic or physical examination evidence of at least one site of unidimensionally-measurable disease, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Must have failed both a taxane and an anthracycline, given sequentially or in combination, either in an adjuvant or metastatic setting
- All acute toxicity of any prior chemotherapy, surgery or radiotherapy must have resolved to National Cancer Institute Common Toxicity Criteria (NCI CTC) Grade less than or equal to 1
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- Lab results, within 10 days of MKC-1 administration:
- Hemoglobin less than or equal to 9 g/dL
- Absolute neutrophil count greater than or equal to 1.5 x 10^9/L
- Platelet count greater than or equal to 75 x 10^9/L
- Serum creatinine less than or equal to 1.5 x ULN (upper limit of normal)
- AST less than or equal to 2.5 x ULN
- Serum albumin greater than or equal to LLN (lower limit of normal)
- Total bilirubin less than or equal to ULN
- Alkaline phosphatase less than or equal to 2.5 x ULN
- Signed informed consent
Who cannot join
- Pre-existing hepatomegaly with disease measures greater than or equal to 2 cm below the costal margin, secondary to malignancy
- Administration of cancer specific therapy within the following periods prior to study drug initiation:
- chemotherapy less than 3 weeks prior
- hormonal therapy less than one week prior
- radiation therapy less than 2 weeks prior
- Be pregnant or lactating; not employing effective birth control
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- Known central nervous system (CNS) metastases unless treated, clinically stable and not requiring steroids
- Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy
- Administration of any investigational agent (therapeutic or diagnostic) within 4 weeks prior to receipt of study medication
- Uncontrolled hypercalcemia (serum calcium-corrected greater than 12 mg/dL)
- Serious cardiac condition
- Any medical conditions that, in the investigator's opinion would impose excessive risk to the patient
- Patients with previous malignancies unless free of recurrence for at least 5 years except basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix
- Treatment with antiretroviral therapy metabolized through CYP3A4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Advanced or Metastatic Breast Cancer
This phase 2 study will determine the antitumor activity, based on the objective rate, of oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. The study will also evaluate the safety and response duration in patients, time to tumor progression, and overall survival in patients following MKC-1 therapy.
- Conditions
- Breast Cancer
- Being tested
- MKC-1
- Keywords
- Advanced and Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MKC-1Drug
Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MKC-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor activity, based on the objective response rate
Measured: every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306631
- Sponsor's protocol ID
- MKC-101
- Status last verified
- Jun 2009
- First submitted
- 22 Mar 2006
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Oral MKC-1 Administered Twice Daily for 14 Consecutive Days Every 4 Weeks in Patients With Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00306631
- Acronym / sponsor ID
- MKC-101
- Conditions
- Breast Cancer
- Keywords
- Advanced and Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 24 Mar 2006 (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.
This phase 2 study will determine the antitumor activity, based on the objective rate, of oral MKC-1, administered twice daily for 14 consecutive days every 4 weeks, in patients with advanced or metastatic breast carcinoma. The study will also evaluate the safety and response duration in patients, time to tumor progression, and overall survival in patients following MKC-1 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MKC-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically or cytologically confirmed advanced or metastatic adenocarcinoma of the breast
- 18 years or older
- Karnofsky performance status greater than or equal to 70%
- Radiographic or physical examination evidence of at least one site of unidimensionally-measurable disease, using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Must have failed both a taxane and an anthracycline, given sequentially or in combination, either in an adjuvant or metastatic setting
Key exclusion criteria (14 listed)
- Pre-existing hepatomegaly with disease measures greater than or equal to 2 cm below the costal margin, secondary to malignancy
- Administration of cancer specific therapy within the following periods prior to study drug initiation:
- Be pregnant or lactating; not employing effective birth control
- Known central nervous system (CNS) metastases unless treated, clinically stable and not requiring steroids
- Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy
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 |
|---|---|---|
| MKC-1Oral capsules, 30 mg and 100 mg capsule strengths; administered twice daily for 14 days in a 28 day cycle | Drug | 1 |
Primary outcome
Antitumor activity, based on the objective response rate
Time frame: every 8 weeks
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 3 Jun 2009.
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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 2 study testing MKC-1 in people with Breast Cancer, run by CASI pharmaceuticals, 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 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 3 Jun 2009. 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 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?
Antitumor activity, based on the objective response rate (time frame: every 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2009; AzTrials last refreshed its copy on 3 Nov 2026.