Ovarian CancerPhase 2NCT00607607
A Phase 2 Study of Oral MKC-1 in Patients With Ovarian or Endometrial Cancer
A Phase 2 study testing MKC-1 in people with Ovarian Cancer and Endometrial Cancer, run by CASI pharmaceuticals, Inc. at 6 sites in Canada.
Trial summary
Patients will be treated with MKC-1, twice daily for 14 consecutive days every four weeks (a cycle of MKC-1 chemotherapy), until disease progression or unacceptable toxicities. Patients will be stratified to Arm A (ovarian cancer) or Arm B (endometrial cancer), and will receive identical treatment regimens. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial 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
- 44 participants
- Where
- 6 sitesCanada
- Study dates
- Jan 2008to Jan 2012
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent (and HIPAA authorization for release of protected health information, as applicable) prior to any study related assessments.
- Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis, fallopian tube cancers, or endometrial cancer.
- Age > 18 years at the time of consent.
- Arm A: Ovarian Cancer Patients:
- Must have failed at least one prior platinum based and one taxane based chemotherapeutic regimen. [Platinum failure is defined as platinum-refractory (progression while receiving a platinum-containing regimen) or platinum-resistant (disease progression within 6 months from completion of platinum containing regimen)].
- Have measurable disease according to RECIST or CA 125 criteria according to GCIG (CA-125 value of > 2 xULN).
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- Have no more than 3 prior regimens for their disease.
- Arm B: Endometrial Cancer Patients:
- Have no more than 3 prior regimens for their disease
- Have measurable disease according to RECIST.
- ECOG performance status of 0, 1, or 2.
- The following laboratory results, within 10 days of MKC-1 administration:
- Hemoglobin greater than or equal to 90 g/L (9 g/dL)
- Absolute neutrophil count greater than or equal to 1.5 x 109/L
- Platelet count greater than or equal to 100 x 109/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 30 g/L (3.0 g/dL)
- Total bilirubin less than or equal to ULN
Who cannot join
- 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.
- Requirement for paracentesis > 2 liters/week.
- 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 10 days before the first MKC-1 administration.
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- Known CNS metastases unless treated, clinically stable, and not requiring steroids.
- Clinical evidence of significant bowel obstruction, active uncontrolled malabsorption syndromes, or a history of total gastrectomy.
- Uncontrolled hypercalcemia (serum calcium-corrected > 3 mmol/L [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. These include: 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 previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix.
- Treatment with antiretroviral therapy metabolized through CYP3A4 (including indinavir, nelfinavir, ritonavir and saquinavir).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9
London Health Sciences Centre
London, Ontario, N6A 4L6
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
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 Recurrent or Resistant Epithelial Ovarian Cancer or Advanced Endometrial Cancer
Patients will be treated with MKC-1, twice daily for 14 consecutive days every four weeks (a cycle of MKC-1 chemotherapy), until disease progression or unacceptable toxicities. Patients will be stratified to Arm A (ovarian cancer) or Arm B (endometrial cancer), and will receive identical treatment regimens.
- Conditions
- Ovarian Cancer, Endometrial Cancer
- Being tested
- MKC-1
- Keywords
- ovarian cancer, endometrial cancer
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MKC-1Drug
capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Ovarian Cancer Patients Receives: Drug: MKC-1 |
| B | Experimental | Endometrial Cancer Patients Receives: Drug: MKC-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125
Measured: Every 4 to 8 weeks
Secondary outcomes (2)
Time to progression
Measured: Time of progression
Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests.
Measured: As reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- CASI pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amit Oza, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607607
- Sponsor's protocol ID
- MKC-103
- Status last verified
- Jan 2012
- First submitted
- 23 Jan 2008
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. 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 Recurrent or Resistant Epithelial Ovarian Cancer or Advanced Endometrial Cancer
- ClinicalTrials.gov ID
- NCT00607607
- Acronym / sponsor ID
- MKC-103
- Conditions
- Ovarian Cancer, Endometrial Cancer
- Keywords
- ovarian cancer, endometrial cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- CASI pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Feb 2008 (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.
Patients will be treated with MKC-1, twice daily for 14 consecutive days every four weeks (a cycle of MKC-1 chemotherapy), until disease progression or unacceptable toxicities. Patients will be stratified to Arm A (ovarian cancer) or Arm B (endometrial cancer), and will receive identical treatment regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MKC-1Ovarian Cancer Patients |
| B | Experimental | Drug: MKC-1Endometrial Cancer Patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Provide written informed consent (and HIPAA authorization for release of protected health information, as applicable) prior to any study related assessments.
- Histologically confirmed epithelial ovarian cancer, primary peritoneal carcinomatosis, fallopian tube cancers, or endometrial cancer.
- Age > 18 years at the time of consent.
- Arm A: Ovarian Cancer Patients:
- ECOG performance status of 0, 1, or 2.
Key exclusion criteria (13 listed)
- Administration of cancer specific therapy within the following periods prior to study drug initiation:
- Requirement for paracentesis > 2 liters/week.
- 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 10 days before the first MKC-1 administration.
- Known CNS metastases unless treated, clinically stable, and not requiring steroids.
- Clinical evidence of significant 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-1capsules, provided 125 mg/m2 BID x 14 days in 28 day cycles | Drug | A, B |
Primary outcome
Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125
Time frame: Every 4 to 8 weeks
2 secondary outcomes
Time to progression
Time frame: Time of progression
Adverse events spontaneously declared by the patients or noted during physical examination and laboratory tests.
Time frame: As reported
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 20 Jan 2012.
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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.
Amit Oza, MD principal investigator
Princess Margaret Hospital, Canada
6 sites 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 Ovarian Cancer and Endometrial Cancer, run by CASI pharmaceuticals, Inc. at 6 sites in Canada.
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 19 inclusion and 13 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 6 sites in Canada. 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?
Tumor response rate (based on tumor measurements according to the RECIST criteria) or CA-125 (time frame: Every 4 to 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 20 Jan 2012.