TumorsPhase 1NCT00800865

A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)

A Phase 1 study testing Biomarker sample collection before and after dosing with cytotoxic agent(s) in people with Tumors, run by Merck Sharp & Dohme LLC.

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

A study to evaluate biomarkers of cancer (context-specific sensitizers) in the skin of participants already receiving cytotoxic therapy. Additional blood and urine samples will be collected for phosphorylated Histone 2AX (γH2AX) and renal toxicity biomarker testing, respectively. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Tumors
What is being tested?: Biomarker sample collection before and after dosing with cytotoxic agent(s)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: No sites listed yet
Study dates: Jan 2009to Oct 2009
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has solid tumor that will be treated with one of the following treatments:
Gemcitabine monotherapy
Cisplatin monotherapy
Carboplatin monotherapy
Gemcitabine and cisplatin combination therapy
Gemcitabine and erlotinib combination therapy

Show all 11Show fewer

Gemcitabine and carboplatin combination therapy
Cisplatin and vinorelbine combination therapy
Cisplatin and pemetrexed combination therapy
Carboplatin and vinorelbine combination therapy
Carboplatin and pemetrexed combination therapy

Who cannot join

Participant has had recent cancer treatments including chemotherapy or radiation
Participant has been in an investigational study within the last 30 days
Participant has a history of drug or alcohol abuse
Participant is Human Immunodeficiency Virus (HIV) positive or has a history of Hepatitis B or C

About this study

Official title: A 2-Stage, Open Label, Phase Ib Clinical Trial to Evaluate Biomarkers in Patients With Solid Tumor and Receiving a Single Dose of Cytotoxics

Conditions: Tumors
Being tested: Biomarker sample collection before and after dosing with cytotoxic agent(s)
Medical subject headings: Neoplasms

What participants receive

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

Biomarker sample collection before and after dosing with cytotoxic agent(s)Other
Participants will have blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s).
Biomarker sample collection before and after dosing with cytotoxic agent(s)Other
A second group of participants will have blood and urine samples collected at Visit 1 (there is no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).

Study groups in NCT00800865
Study group	Role	What they receive
Biomarker Evaluation Group I	Other	Biomarker evaluation before and after dosing with cytotoxic agent(s) Receives: Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)
Biomarker Evaluation Group II	Other	Biomarker evaluation before and after dosing with cytotoxic agent(s) Receives: Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)

What is being measured

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

Level of Biomarkers
Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).
Measured: Baseline, 24, 32, and 48 hours post dose
Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy
Ratio of Phospho-CDC2 (pCDC2) response at 24, 32, and 48 hours compared to baseline, 24, and 32 hours post chemotherapy.
Measured: 24, 32, and 48 hours post dose

Timeline

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

Jan 2009Oct 2009

First posted2 Dec 2008 (estimated)
Study startJan 2009
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TumorsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00800865
Sponsor's protocol ID: 0000-097
Other IDs: 2008_593
Status last verified: Oct 2015
First submitted: 1 Dec 2008
Last updated: 3 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sun A, Lam R, Harman A, Pavlick A, Herman G, Dauffenbach L, Kerfoot C, Huang P, Cheng J, Demuth T, Iannone R. Induction of CDC2 phosphylation in skin biopsies from patients with solid tumors undergoing DNA-damaging chemotherapy. Global J Med Res. 2014;14(1-K):11-21

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
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RecruitingPhase 2
Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
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RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Advanced Stage Solid Tumors

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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 2-Stage, Open Label, Phase Ib Clinical Trial to Evaluate Biomarkers in Patients With Solid Tumor and Receiving a Single Dose of Cytotoxics
ClinicalTrials.gov ID: NCT00800865
Acronym / sponsor ID: 0000-097
Conditions: Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 2 Dec 2008 (estimated)
Results: Posted 4 Oct 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Biomarker Evaluation Group I	Other	Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)Biomarker evaluation before and after dosing with cytotoxic agent(s)
Biomarker Evaluation Group II	Other	Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)Biomarker evaluation before and after dosing with cytotoxic agent(s)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Gemcitabine monotherapy
Cisplatin monotherapy
Carboplatin monotherapy
Gemcitabine and cisplatin combination therapy
Gemcitabine and erlotinib combination therapy

Key exclusion criteria (4 listed)

Participant has had recent cancer treatments including chemotherapy or radiation
Participant has been in an investigational study within the last 30 days
Participant has a history of drug or alcohol abuse
Participant is Human Immunodeficiency Virus (HIV) positive or has a history of Hepatitis B or C

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
Biomarker sample collection before and after dosing with cytotoxic agent(s)Participants will have blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s).	Other	Biomarker Evaluation Group I
Biomarker sample collection before and after dosing with cytotoxic agent(s)A second group of participants will have blood and urine samples collected at Visit 1 (there is no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).	Other	Biomarker Evaluation Group II

Primary outcome

Level of Biomarkers
Time frame: Baseline, 24, 32, and 48 hours post dose
Phospho-CDC2 (pCDC2) response in the skin following the administration of cytotoxic agents. pCDC2 levels were measured by immunohistochemistry (IHC).
Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy
Time frame: 24, 32, and 48 hours post dose
Ratio of Phospho-CDC2 (pCDC2) response at 24, 32, and 48 hours compared to baseline, 24, and 32 hours post chemotherapy.

Results and safety

Results posted to the registry on 4 Oct 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biomarker Evaluation Group I	15	15
Biomarker Evaluation Group II	16	16

Primary outcome: Level of Biomarkers

Time frame: Baseline, 24, 32, and 48 hours post dose. Geometric mean (90% Confidence Interval). Unit: Percent pCDC2-positive cells

Measure	Biomarker Evaluation Group I n = 15	Biomarker Evaluation Group II n = 16
Baseline	24.6 (1.7)	NA (NA)
24 hours post chemotherapy	34.3 (1.9)	23.0 (1.9)
32 hours post chemotherapy	NA (NA)	23.7 (2.0)
48 hours post chemotherapy	50.3 (1.7)	29.9 (1.8)

Population analysed: Actual number of participants analyzed in Part I varied from 13 to 15, depending on time point. Actual number of participants analyzed in Part II was 16 for all time points.

Primary outcome: Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy

Time frame: 24, 32, and 48 hours post dose. Mean (90% Confidence Interval). Unit: Ratio

Measure	Biomarker Evaluation Group I n = 15	Biomarker Evaluation Group II n = 16
24 hours post chemotherapy/baseline	1.40 (1.59)	NA (NA)
48 hours post chemotherapy/baseline	2.05 (1.78)	NA (NA)
32 hours/24 hours post chemotherapy	NA (NA)	1.03 (1.60)
48 hours/24 hours post chemotherapy	1.47 (NA)	1.30 (1.80)
48 hours/32 hours post chemotherapy	NA (NA)	1.26 (1.75)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biomarker Evaluation Group I	0 of 15 (0%)	4 of 15 (26.7%)	Not reported
Biomarker Evaluation Group II	0 of 16 (0%)	2 of 16 (12.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationSun A, Lam R, Harman A, Pavlick A, Herman G, Dauffenbach L, Kerfoot C, Huang P, Cheng J, Demuth T, Iannone R. Induction of CDC2 phosphylation in skin biopsies from patients with solid tumors undergoing DNA-damaging chemotherapy. Global J Med Res. 2014;14(1-K):11-21

Related trials for Tumors

Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
Not yet recruitingPhase 3
Sequential Chemotherapy Followed by Ultrahypofractionated Radiotherapy for Muscle-Invasive Bladder Cancer
Bladder Cancer, TURBT
RecruitingPhase 2
Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers
Gastrointestinal Cancers
RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Advanced Stage Solid Tumors

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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biomarker sample collection before and after dosing with cytotoxic agent(s) in people with Tumors, run by Merck Sharp & Dohme LLC.

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 11 inclusion and 4 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 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 4 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Level of Biomarkers (time frame: Baseline, 24, 32, and 48 hours post dose). The study lists 2 primary outcomes in all. 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 NCT00800865, 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 3 Nov 2015.