Small Cell Lung CancerPhase 1NCT00455052
A Study of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
A Phase 1 study testing XMT-1001 in people with Small Cell Lung Cancer and Non-small Cell Lung Cancer, run by Mersana Therapeutics at 12 sites in United States.
Trial summary
This amended expansion phase of the protocol is to further the experience at a dose level of 150 mg CPT eq/m2 in patients with Stage IV non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) and to test for preliminary anti-tumor activity in these tumor types. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- XMT-1001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 1
- 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
- At least 18 years old
- Have histological or cytological documentation of one of the following:
- NSCLC with Stage IV disease according to the American Joint Cancer Commission TNM Staging (7th Edition)
- Have received at least one prior chemotherapy regimen but no more than two chemotherapy regimens for their advanced disease (not containing irinotecan or topotecan).
- Adjuvant chemotherapy will be considered as a prior chemotherapy regimen only if it is completed less than 6 months prior to enrollment.
- Treatment with erlotinib or crizotinib as single agents will not be considered as a chemotherapy regimen for purposes of this trial OR B. SCLC with Stage IV (extensive) or recurrent disease after definitive treatment for limited stage disease according to the American Joint Cancer Commission TNM Staging (7th Edition)1
Show all 25Show fewer
- Have received at least one prior chemotherapy regimen but no more than two chemotherapy regimens for their advanced disease (not containing irinotecan or topotecan).
- Adjuvant chemotherapy will be considered as a prior chemotherapy regimen only if it is completed less than 6 months prior to enrollment.
- Patients must be refractory or resistant to standard therapy or for whom standard therapy is not anticipated to be curative and who have progressed through prior regimens.
- Patients must have measurable disease with at least one lesion that can be accurately measured by Response Evaluation Criteria in Solid Tumors (RECIST). The lesion size must be ≥20 mm by conventional radiological techniques or ≥10 mm by spiral CT scan. Disease in an irradiated field as the only site of measurable disease is acceptable if there has been a clear progression of the lesion. PET scans are not suitable for providing these measurements. For patients who are sensitive to contrast, MRI may be used.
- Patients with CNS metastases are acceptable provided that the disease has been treated (e.g. surgery, whole brain radiotherapy, stereotactic radiotherapy etc.) and the patient is stable for at least two weeks and does not require steroids (at least one week off steroids). Anti-seizure medication is allowed at the discretion of the treating physician.
- At least 42 days since administration of mitomycin or nitrosoureas, and 28 days since any other chemotherapy, investigational agent, and/or radiation therapy.
- Have the following laboratory values:
- Absolute neutrophil count (ANC) ≥1500 cells/mm3
- Platelet count >100,000 cells/mm3
- Hemoglobin ≥9.0 g/dL
- Adequate renal function (serum creatinine ≤2 mg/dL) and creatinine clearance ≥45 mL/min (Calculated by Cockroft and Gault method)
- Adequate hepatic function (bilirubin ≤1.5 mg/dL)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the institutional upper limit of normal (ULN, or
- 5 times the ULN if liver metastases are present)
- Albumin of >3.0 g/dL
- PT and PTT ≤1.5 times the ULN
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.
- Have a life expectancy of at least 3 months.
- Have signed an informed consent form.
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Institute of Translational Oncology Research
Greenville, South Carolina, 29605
Central Indiana Cancer Centers
Indianapolis, Indiana, 46219
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
New York Oncology Hematology
New York, New York, 12208
Virginia Oncology Associates
Norfolk, Virginia, 23502
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, 85258
Evergreen Hematology & Oncology
Spokane, Washington, 99218
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, 97477
Texas Oncology - Tyler
Tyler, Texas, 75702
Vancouver Cancer Center
Vancouver, Washington, 98684
About this study
Official title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
This amended expansion phase of the protocol is to further the experience at a dose level of 150 mg CPT eq/m2 in patients with Stage IV non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) and to test for preliminary anti-tumor activity in these tumor types. The MTD was initially defined as 113 mg CPT equivalents(eq)/m2 in the dose escalation part of the study. However, in the initial expansion phase (Protocol Amendment 11), 11 patients (10 NSCLC patients and 1 gastric cancer patients) were dosed at 113 mg CPT eq/m2 and less bone marrow toxicity was observed as compared to more heavily pre-treated patients in the dose escalation part of the study. Therefore, this amended expansion phase will investigate the safety and anti-tumor effects of a dose of 150 mg CPT eq/m2.
The study will also determine:
- The safety and tolerability of XMT-1001 at 150 mg CPT eq/m2
- The pharmacokinetics (PK) of XMT-1001 (how XMT-1001 behaves in the body) in patients Stage IV non-small cell lung carcinoma (NSCLC) and small cell lung cancer
- Evidence of XMT-1001 anti-tumor activity at 150 mg CPT eq/m2
Read the detailed description
This is an open-label study of XMT-1001 administered intravenously over 4 hours every 21 days (1 Cycle). Blood sampling for PK analyses will be performed immediately prior to dosing, and 9 times after dosing. Patients will be assessed for toxicities known to occur with other drugs of this class, such as bone marrow suppression, elevated liver function enzymes, hemorrhagic cystitis, and diarrhea. Tumor imaging will be performed every 2 cycles.
- Conditions
- Small Cell Lung Cancer, Non-small Cell Lung Cancer
- Being tested
- XMT-1001
- Keywords
- XMT-1001, cancer, tumor, camptothecin, Fleximer, polymer, Phase 1, safety, pharmacokinetics, maximum tolerated dose, NSCLC, non-small cell lung cancer, SCLC, small cell lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XMT-1001Drug
Also called MER-1001
XMT-1001 is administered as an IV infusion once every 21 days. This expansion of the Phase 1 study is to confirm the MTD.
| Study group | Role | What they receive |
|---|---|---|
| XMT-1001 | Experimental | XMT-1001 is administered I.V. every 21 days. Groups of 3 patients are given one dose and the dose increases for each group. The first dose level is 17 mg/m^2, the next dose level is 30 mg/m^2, followed by dose levels: 50 mg/m^2, 80 mg/m^2, 120 mg/m^2, 150 mg/m^2, and 190 mg/m^2 until disease progressions or unacceptable side effects are experienced. Receives: Drug: XMT-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Every 7 days in each 21 day cycle
Secondary outcomes (2)
Tumor response
Measured: Every 2 cycles
Time to tumor progression
Measured: Every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Cell Lung 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersana Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Sausville, MD, Principal investigator, University of Maryland Greenebaum Cancer CenterGlen J Weiss, MD, Principal investigator, TGen Clinical Research Services at Scottsdale HealthcareLawrence Garbo, MD, Principal investigator, New York Oncology HematologyAllen Lee Cohn, MD, Principal investigator, Rocky Mountain Cancer CentersPaul R. Conkling, MD, Principal investigator, Virginia Oncology AssociatesWilliam J Edenfield, MD, Principal investigator, Institute for Translational Oncology ResearchDonald A. Richards, MD, Principal investigator, Texas Oncology - TylerJohn R. Caton, MD, Principal investigator, Willamette Valley Cancer Institute and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455052
- Sponsor's protocol ID
- MER-001
- Status last verified
- Jan 2017
- First submitted
- 1 Apr 2007
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yurkovetskiy AV, Hiller A, Syed S, Yin M, Lu XM, Fischman AJ, Papisov MI. Synthesis of a macromolecular camptothecin conjugate with dual phase drug release. Mol Pharm. 2004 Sep-Oct;1(5):375-82. doi: 10.1021/mp0499306.
PubMed 16026008
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous XMT-1001 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00455052
- Acronym / sponsor ID
- MER-001
- Conditions
- Small Cell Lung Cancer, Non-small Cell Lung Cancer
- Keywords
- XMT-1001, cancer, tumor, camptothecin, Fleximer, polymer, Phase 1, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mersana TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 3 Apr 2007 (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 amended expansion phase of the protocol is to further the experience at a dose level of 150 mg CPT eq/m2 in patients with Stage IV non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) and to test for preliminary anti-tumor activity in these tumor types. The MTD was initially defined as 113 mg CPT equivalents(eq)/m2 in the dose escalation part of the study. However, in the initial expansion phase (Protocol Amendment 11), 11 patients (10 NSCLC patients and 1 gastric cancer patients) were dosed at 113 mg CPT eq/m2 and less bone marrow toxicity was observed as compared to more heavily pre-treated patients in the dose escalation part of the study. Therefore, this amended expansion phase will investigate the safety and anti-tumor effects of a dose of 150 mg CPT eq/m2.
The study will also determine:
- The safety and tolerability of XMT-1001 at 150 mg CPT eq/m2
- The pharmacokinetics (PK) of XMT-1001 (how XMT-1001 behaves in the body) in patients Stage IV non-small cell lung carcinoma (NSCLC) and small cell lung cancer
- Evidence of XMT-1001 anti-tumor activity at 150 mg CPT eq/m2
Detailed description
This is an open-label study of XMT-1001 administered intravenously over 4 hours every 21 days (1 Cycle). Blood sampling for PK analyses will be performed immediately prior to dosing, and 9 times after dosing. Patients will be assessed for toxicities known to occur with other drugs of this class, such as bone marrow suppression, elevated liver function enzymes, hemorrhagic cystitis, and diarrhea. Tumor imaging will be performed every 2 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XMT-1001 | Experimental | Drug: XMT-1001XMT-1001 is administered I.V. every 21 days. Groups of 3 patients are given one dose and the dose increases for each group. The first dose level is 17 mg/m^2, the next dose level is 30 mg/m^2, followed by dose levels: 50 mg/m^2, 80 mg/m^2, 120 mg/m^2, 150 mg/m^2, and 190 mg/m^2 until disease progressions or unacceptable side effects are experienced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- At least 18 years old
- Have histological or cytological documentation of one of the following:
- Patients must be refractory or resistant to standard therapy or for whom standard therapy is not anticipated to be curative and who have progressed through prior regimens.
- Patients must have measurable disease with at least one lesion that can be accurately measured by Response Evaluation Criteria in Solid Tumors (RECIST). The lesion size must be ≥20 mm by conventional radiological techniques or ≥10 mm by spiral CT scan. Disease in an irradiated field as the only site of measurable disease is acceptable if there has been a clear progression of the lesion. PET scans are not suitable for providing these measurements. For patients who are sensitive to contrast, MRI may be used.
- Patients with CNS metastases are acceptable provided that the disease has been treated (e.g. surgery, whole brain radiotherapy, stereotactic radiotherapy etc.) and the patient is stable for at least two weeks and does not require steroids (at least one week off steroids). Anti-seizure medication is allowed at the discretion of the treating physician.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| XMT-1001Also: MER-1001XMT-1001 is administered as an IV infusion once every 21 days. This expansion of the Phase 1 study is to confirm the MTD. | Drug | XMT-1001 |
Primary outcome
Adverse Events
Time frame: Every 7 days in each 21 day cycle
2 secondary outcomes
Tumor response
Time frame: Every 2 cycles
Time to tumor progression
Time frame: Every 2 cycles
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 31 Jan 2018.
- Background: PubMed 16026008Yurkovetskiy AV, Hiller A, Syed S, Yin M, Lu XM, Fischman AJ, Papisov MI. Synthesis of a macromolecular camptothecin conjugate with dual phase drug release. Mol Pharm. 2004 Sep-Oct;1(5):375-82. doi: 10.1021/mp0499306.
- Individual participant dataSharing planned: No
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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.
Edward Sausville, MD principal investigator
University of Maryland Greenebaum Cancer Center
Glen J Weiss, MD principal investigator
TGen Clinical Research Services at Scottsdale Healthcare
Lawrence Garbo, MD principal investigator
New York Oncology Hematology
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XMT-1001 in people with Small Cell Lung Cancer and Non-small Cell Lung Cancer, run by Mersana Therapeutics at 12 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 25 inclusion and 0 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 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.
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?
Adverse Events (time frame: Every 7 days in each 21 day cycle). 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 NCT00455052, which also lists 1 linked publication.
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 31 Jan 2018.