AdenocarcinomaPhase 2NCT00129844
Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer
A Phase 2 study testing Motexafin Gadolinium in people with Adenocarcinoma and Non-Small-Cell Lung Carcinoma, run by Pharmacyclics LLC. at 16 sites in 2 countries.
Trial summary
The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Non-Small-Cell Lung Carcinoma, Lung Neoplasms
- What is being tested?
- Motexafin Gadolinium
- How many people
- 108 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Sep 2005to Dec 2007
- 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
- >18 years old
- Histologically or cytologically confirmed diagnosis of NSCLC
- Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC patients who have received one prior platinum-based chemotherapy regimen
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- ECOG performance status score of 0 or 1
- Willing and able to provide written informed consent
Who cannot join
- Laboratory values of:
- Absolute neutrophil count < 1500/ul;
- Platelet count < 75,000/ul;
- Hemoglobin < 10 gm/dl;
- AST or ALT > 3 x the upper limit of normal (ULN);
- Alkaline phosphatase > 5 x ULN;
Show all 22Show fewer
- Bilirubin > 2 x ULN;
- Serum creatinine > 2.0 mg/dL.
- Symptomatic or uncontrolled (untreated or treated and progressing) brain metastasis.
- Evidence of meningeal metastasis.
- Greater than one prior cytotoxic regimen (not counting adjuvant or neoadjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen).
- Chemotherapy, radiation therapy, experimental therapy, immunotherapy or systemic biologic anticancer therapy within 21 days before beginning study treatment.
- Significant weight loss > 10% of body weight in preceding 6 weeks.
- Treatment for another cancer within 3 years of enrollment, unless basal cell carcinoma or cervical cancer in situ.
- Myocardial infarction within 6 months of enrollment or congestive heart failure rated New York Heart Association (NYHA) Class III or IV.
- Uncontrolled hypertension (systolic blood pressure > 160 mm Hg and diastolic blood pressure > 110 mm Hg on maximal medical therapy).
- Known history of porphyria (testing not required at screening visit).
- Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening visit).
- Known history of HIV infection (testing not required at screening visit).
- Female who is pregnant or lactating (serum pregnancy test is required for all female patients of childbearing potential).
- Sexually active male or female of childbearing potential unwilling to use adequate contraceptive protection.
- Physical or mental condition that makes patient unable to complete specified follow-up assessments.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States11 sites
Study site
Akron, Ohio
Study site
Albuquerque, New Mexico
Study site
Columbia, Missouri
Study site
Fountain Valley, California
Study site
Knoxville, Tennessee
Study site
Los Angeles, California
Study site
Nashville, Tennessee
Study site
Omaha, Nebraska
Study site
Palm Springs, California
Study site
Rochester, New York
Study site
St Louis, Missouri
Canada5 sites
Study site
Calgary, Alberta
Study site
Edmonton, Alberta
Study site
Kingston, Ontario
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
About this study
Official title: Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer
The purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.
Read the detailed description
Outline:
Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms:
Arm A - 10 mg/kg MGd once per week
Arm B - 15 mg/kg MGd once every 3 weeks
Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study.
At the end of Stage I, both treatment arms will be evaluated, and only the arm(s) that demonstrate at least one response (Complete Response or Partial Response) will proceed to Stage II. If both arms demonstrate a response, then both will proceed to Stage II.
- Being tested
- Motexafin Gadolinium
- Keywords
- Motexafin Gadolinium, non-small cell, lung cancer, Lung cancer, cancer of the lung, Carcinoma, Non-Small-Cell Lung
- Medical subject headings
- Adenocarcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motexafin GadoliniumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC
Secondary outcomes (4)
To select the most effective regimen based on tumor response
To estimate the time to progression
To estimate survival
To evaluate the safety and tolerability of 2 dosing regimens of MGd in NSCLC patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionJun 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacyclics LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Natale, M.D., Study chair, Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129844
- Sponsor's protocol ID
- PCYC-0227
- Status last verified
- Aug 2008
- First submitted
- 10 Aug 2005
- Last updated
- 20 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Single Agent Motexafin Gadolinium for Second Line Treatment of Non-Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00129844
- Acronym / sponsor ID
- PCYC-0227
- Keywords
- Motexafin Gadolinium, non-small cell, lung cancer, Lung cancer, cancer of the lung, Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Pharmacyclics LLC.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Aug 2005 (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 purpose of this study is to determine the effect of MGd in non-small-cell lung cancer (NSCLC) when given alone, and to evaluate the difference between two dosing regimens.
Detailed description
Outline:
Two-arm, open-label, randomized, 2-stage Phase II trial. Patients will be randomized on the first stage to 1 of 2 treatment arms:
Arm A - 10 mg/kg MGd once per week
Arm B - 15 mg/kg MGd once every 3 weeks
Patients will be treated on 3 week cycles, up to a maximum of 8 cycles (24 weeks). Patients with either objective response or stable disease after 2 cycles will receive up to 8 cycles of therapy. Patients with progressive disease will be terminated from the study.
At the end of Stage I, both treatment arms will be evaluated, and only the arm(s) that demonstrate at least one response (Complete Response or Partial Response) will proceed to Stage II. If both arms demonstrate a response, then both will proceed to Stage II.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >18 years old
- Histologically or cytologically confirmed diagnosis of NSCLC
- Unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC patients who have received one prior platinum-based chemotherapy regimen
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- ECOG performance status score of 0 or 1
Key exclusion criteria (22 listed)
- Laboratory values of:
- Symptomatic or uncontrolled (untreated or treated and progressing) brain metastasis.
- Evidence of meningeal metastasis.
- Greater than one prior cytotoxic regimen (not counting adjuvant or neoadjuvant cytotoxic chemotherapy if completed > 12 months prior to cytotoxic regimen).
- Chemotherapy, radiation therapy, experimental therapy, immunotherapy or systemic biologic anticancer therapy within 21 days before beginning study treatment.
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 |
|---|---|---|
| Motexafin Gadolinium | Drug | – |
Primary outcome
To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC
4 secondary outcomes
To select the most effective regimen based on tumor response
To estimate the time to progression
To estimate survival
To evaluate the safety and tolerability of 2 dosing regimens of MGd in NSCLC patients
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 Aug 2008.
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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.
Robert Natale, M.D. study chair
Aptium Oncology, Inc. Cedars-Sinai Outpatient Cancer Center
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motexafin Gadolinium in people with Adenocarcinoma and Non-Small-Cell Lung Carcinoma, run by Pharmacyclics LLC. at 16 sites in 2 countries.
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 6 inclusion and 22 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 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, 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?
To estimate the response rates of two different MGd dosing regimens for the treatment of NSCLC. 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 Aug 2008.