Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01096355
Gamma-Secretase Inhibitor RO4929097 in Treating Patients With Metastatic or Unresectable Solid Malignancies
A Phase 1 study testing gamma-secretase/Notch signalling pathway inhibitor RO4929097, diagnostic laboratory biomarker analysis and pharmacogenomic studies in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 3 sites in Canada.
Trial summary
This phase I trial is studying the side effects, best way to give, and best dose of gamma-secretase inhibitor RO4929097 in treating patients with metastatic or unresectable solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- gamma-secretase/Notch signalling pathway inhibitor RO4929097, diagnostic laboratory biomarker analysis and pharmacogenomic studies
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2010to Jul 2012
- 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
- Histologically or cytologically confirmed solid malignancy
- Metastatic or unresectable disease
- Standard curative or palliative measures do not exist or are no longer effective
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- No known brain metastases
- ECOG performance status (PS) 0-1 (Karnofsky PS 70-100%)
Show all 50Show fewer
- Life expectancy > 12 weeks
- Leukocytes ≥ 3,000/mm^3
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Total bilirubin normal
- AST/ALT ≤ 2.5 times upper limit of normal
- Serum creatinine normal OR creatinine clearance ≥ 60 mL/min
- No uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia, or hypokalemia, defined as < lower limit of normal despite adequate electrolyte supplementation
- QTc ≤ 450 msec in males and a QTc ≤ 470 in females, as measured by ECG using Bazett's formula
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 forms of contraception (i.e., barrier contraception and 1 other method of contraception) for ≥ 4 weeks before, during, and for ≥ 12 months after completion of study treatment
- Willing to undergo 2 tumor biopsies (unless medically contraindicated)
- Able to swallow medication
- No malabsorption syndrome or other condition that would interfere with intestinal absorption
- No diarrhea ≥ grade 2 not under control with standard antidiarrhea medications
- No uncontrolled concurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia other than chronic, stable atrial fibrillation
- Psychiatric illness or social situations that would limit compliance with study requirements
- No history of risk factors for QT interval prolongation including, but not limited to, a family or personal history of any of the following:
- Long QT syndrome
- A history of torsades de pointes
- Recurrent syncope without known etiology
- Sudden unexpected death
- Female patients may not donate ova during or after study treatment
- No blood donation during and for ≥ 12 months after completion of study treatment
- No serologic positivity for hepatitis A, B, or C; history of liver disease; or other forms of hepatitis or cirrhosis
- No HIV-positive patients on combination antiretroviral therapy
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to gamma-secretase inhibitor RO4929097 or other agents used in this study
- No other concurrent agents or therapies administered with the intent to treat the patient's malignancy
- No prior gamma-secretase inhibitors
- Any number of prior treatment regimens allowed
- At least 4 weeks since prior radiotherapy or systemic therapy (6 weeks for prior carmustine or mitomycin C)
- Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy for symptomatic palliation
- Recovered from the adverse events due to prior therapy to < CTCAE grade 2 (except alopecia)
- No other concurrent investigational agents
- No concurrent medications with narrow therapeutic indices that are metabolized by cytochrome P450, including warfarin sodium (Coumadin®)
- No concurrent medications that are strong inducers/inhibitors or substrates of CYP3A4
- No concurrent medications or food that may interfere with the metabolism of gamma-secretase inhibitor RO4929097 including ketoconazole, grapefruit, or grapefruit juice
- No antiarrhythmics or other concurrent medications with known potential to prolong QT interval
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: A Phase I Study of Various Administration Schedules of RO4929097 With Multi-parameter Assessment (Biomarkers, Pharmacokinetics, Pharmacodynamics) in Patients With Advanced Solid Cancers
This phase I trial is studying the side effects, best way to give, and best dose of gamma-secretase inhibitor RO4929097 in treating patients with metastatic or unresectable solid malignancies. Enzyme inhibitors, such as gamma-secretase inhibitor RO4929097, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety profile of 6 different administration schedules of gamma-secretase inhibitor RO4929097 in patients with advanced solid malignancies.
SECONDARY OBJECTIVES:
- To determine pharmacokinetic (PK) parameters of gamma-secretase inhibitor RO4929097 administered using 6 different administration schedules.
II. To assess the preliminary antitumor activity of gamma-secretase inhibitor RO4929097 in these patients.
TERTIARY OBJECTIVES:
- To assess the pharmacodynamic (PD) effects of gamma-secretase inhibitor RO4929097 on Notch signaling pathway in tumor and surrogate tissues, as well as soluble markers of angiogenesis in plasma, when administered using 6 different dosing schedules. (Exploratory) II. To evaluate the relationship between PK and PD effects in an attempt to define the optimal biological dosing schedule (OBDS) that can provide a sustained inhibition of Notch signaling pathway over time with a tolerable toxicity profile. (Exploratory) III. To correlate inhibition of Notch signaling pathway measured in tumor and surrogate tissues with preliminary antitumor activity and assess the potential clinical predictive value of OBDS as defined above. (Exploratory) IV. To assess the effect of the various pharmacogenomic polymorphisms of the cytochrome P450 pathway on PK and PD parameters. (Exploratory)
OUTLINE: This is a multicenter, dose-escalation study. Patients are assigned to 1 of 6 dose schedules.
GROUP A: Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3 and 8-10.
GROUP B: Patients receive oral RO4929097 once daily on days 1-7.
GROUP C: Patients receive oral RO4929097 once daily on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21.
GROUP D: Patients receive oral RO4929097 once daily on days 1, 8, and 15.
GROUP E: Patients receive oral RO4929097 once daily on days 1, 4, 8, 11, 15, and 18.
GROUP F: Patients receive oral RO4929097 once daily days 1-5, 8-12, and 15-19.
Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis.
After completion of study treatment, patients are followed up for 4 weeks.
- Being tested
- gamma-secretase/Notch signalling pathway inhibitor RO4929097, diagnostic laboratory biomarker analysis, pharmacogenomic studies, pharmacological study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gamma-secretase/Notch signalling pathway inhibitor RO4929097Drug
Also called R4733, RO4929097
diagnostic laboratory biomarker analysisOther
pharmacogenomic studiesOther
Also called Pharmacogenomic Study
Also called pharmacological studies
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3 and 8-10.
Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. Receives: Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097; Other: diagnostic laboratory biomarker analysis; Other: pharmacogenomic studies; Other: pharmacological study |
| Group B | Experimental | Patients receive oral RO4929097 once daily on days 1-7.
Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. Receives: Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097; Other: diagnostic laboratory biomarker analysis; Other: pharmacogenomic studies; Other: pharmacological study |
| Group C | Experimental | Patients receive oral RO4929097 once daily on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21.
Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. Receives: Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097; Other: diagnostic laboratory biomarker analysis; Other: pharmacogenomic studies; Other: pharmacological study |
| Group D | Experimental | Patients receive oral RO4929097 once daily on days 1, 8, and 15.
Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. Receives: Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097; Other: diagnostic laboratory biomarker analysis; Other: pharmacogenomic studies; Other: pharmacological study |
| Group E | Experimental | Patients receive oral RO4929097 once daily on days 1, 4, 8, 11, 15, and 18.
Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. Receives: Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097; Other: diagnostic laboratory biomarker analysis; Other: pharmacogenomic studies; Other: pharmacological study |
| Group F | Experimental | Patients receive oral RO4929097 once daily days 1-5, 8-12, and 15-19.
Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. Receives: Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097; Other: diagnostic laboratory biomarker analysis; Other: pharmacogenomic studies; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety profile of six different administration schedules of RO4929097
Measured: Up to 4 weeks
Secondary outcomes (3)
Determination of pharmacokinetic profiles of various administration schedules
Measured: Up to 4 weeks
Preliminary antitumor activity of RO4929097 assessed using RECIST 1.1 criteria
Measured: Up to 4 weeks
Pharmacokinetic (PK) parameters of RO4929097 administered using six different dosing schedules
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, Principal investigator, University Health Network-Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096355
- Sponsor's protocol ID
- NCI-2011-01550
- Other IDs
- NCI-2011-01550, CDR0000666959, PMH-PJC-003, PJC-003, 8501, U01CA132123
- Status last verified
- Dec 2013
- First submitted
- 30 Mar 2010
- Last updated
- 2 Apr 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Various Administration Schedules of RO4929097 With Multi-parameter Assessment (Biomarkers, Pharmacokinetics, Pharmacodynamics) in Patients With Advanced Solid Cancers
- ClinicalTrials.gov ID
- NCT01096355
- Acronym / sponsor ID
- NCI-2011-01550
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 2010
- Primary completion
- Jul 2012 (actual)
- First posted
- 31 Mar 2010 (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 I trial is studying the side effects, best way to give, and best dose of gamma-secretase inhibitor RO4929097 in treating patients with metastatic or unresectable solid malignancies. Enzyme inhibitors, such as gamma-secretase inhibitor RO4929097, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety profile of 6 different administration schedules of gamma-secretase inhibitor RO4929097 in patients with advanced solid malignancies.
SECONDARY OBJECTIVES:
- To determine pharmacokinetic (PK) parameters of gamma-secretase inhibitor RO4929097 administered using 6 different administration schedules.
II. To assess the preliminary antitumor activity of gamma-secretase inhibitor RO4929097 in these patients.
TERTIARY OBJECTIVES:
- To assess the pharmacodynamic (PD) effects of gamma-secretase inhibitor RO4929097 on Notch signaling pathway in tumor and surrogate tissues, as well as soluble markers of angiogenesis in plasma, when administered using 6 different dosing schedules. (Exploratory) II. To evaluate the relationship between PK and PD effects in an attempt to define the optimal biological dosing schedule (OBDS) that can provide a sustained inhibition of Notch signaling pathway over time with a tolerable toxicity profile. (Exploratory) III. To correlate inhibition of Notch signaling pathway measured in tumor and surrogate tissues with preliminary antitumor activity and assess the potential clinical predictive value of OBDS as defined above. (Exploratory) IV. To assess the effect of the various pharmacogenomic polymorphisms of the cytochrome P450 pathway on PK and PD parameters. (Exploratory)
OUTLINE: This is a multicenter, dose-escalation study. Patients are assigned to 1 of 6 dose schedules.
GROUP A: Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3 and 8-10.
GROUP B: Patients receive oral RO4929097 once daily on days 1-7.
GROUP C: Patients receive oral RO4929097 once daily on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21.
GROUP D: Patients receive oral RO4929097 once daily on days 1, 8, and 15.
GROUP E: Patients receive oral RO4929097 once daily on days 1, 4, 8, 11, 15, and 18.
GROUP F: Patients receive oral RO4929097 once daily days 1-5, 8-12, and 15-19.
Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis.
After completion of study treatment, patients are followed up for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097, Other: diagnostic laboratory biomarker analysis, Other: pharmacogenomic studies, Other: pharmacological studyPatients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3 and 8-10. Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. |
| Group B | Experimental | Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097, Other: diagnostic laboratory biomarker analysis, Other: pharmacogenomic studies, Other: pharmacological studyPatients receive oral RO4929097 once daily on days 1-7. Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. |
| Group C | Experimental | Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097, Other: diagnostic laboratory biomarker analysis, Other: pharmacogenomic studies, Other: pharmacological studyPatients receive oral RO4929097 once daily on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21. Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. |
| Group D | Experimental | Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097, Other: diagnostic laboratory biomarker analysis, Other: pharmacogenomic studies, Other: pharmacological studyPatients receive oral RO4929097 once daily on days 1, 8, and 15. Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. |
| Group E | Experimental | Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097, Other: diagnostic laboratory biomarker analysis, Other: pharmacogenomic studies, Other: pharmacological studyPatients receive oral RO4929097 once daily on days 1, 4, 8, 11, 15, and 18. Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. |
| Group F | Experimental | Drug: gamma-secretase/Notch signalling pathway inhibitor RO4929097, Other: diagnostic laboratory biomarker analysis, Other: pharmacogenomic studies, Other: pharmacological studyPatients receive oral RO4929097 once daily days 1-5, 8-12, and 15-19. Treatment in all groups repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsies at baseline and between days 15 and 22 in the first course of treatment. Plasma samples are collected periodically for pharmacokinetic, pharmacodynamic, and pharmacogenomic analysis and to assess levels of adipsin and markers of angiogenesis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (50 listed)
- Histologically or cytologically confirmed solid malignancy
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
- No known brain metastases
- ECOG performance status (PS) 0-1 (Karnofsky PS 70-100%)
- Life expectancy > 12 weeks
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 |
|---|---|---|
| gamma-secretase/Notch signalling pathway inhibitor RO4929097Also: R4733, RO4929097 | Drug | Group A, Group B, Group C, Group D, Group E, Group F |
| diagnostic laboratory biomarker analysis | Other | Group A, Group B, Group C, Group D, Group E, Group F |
| pharmacogenomic studiesAlso: Pharmacogenomic Study | Other | Group A, Group B, Group C, Group D, Group E, Group F |
| pharmacological studyAlso: pharmacological studies | Other | Group A, Group B, Group C, Group D, Group E, Group F |
Primary outcome
Safety profile of six different administration schedules of RO4929097
Time frame: Up to 4 weeks
3 secondary outcomes
Determination of pharmacokinetic profiles of various administration schedules
Time frame: Up to 4 weeks
Preliminary antitumor activity of RO4929097 assessed using RECIST 1.1 criteria
Time frame: Up to 4 weeks
Pharmacokinetic (PK) parameters of RO4929097 administered using six different dosing schedules
Time frame: Up to 4 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 2 Apr 2014.
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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.
Lillian Siu principal investigator
University Health Network-Princess Margaret Hospital
3 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 gamma-secretase/Notch signalling pathway inhibitor RO4929097, diagnostic laboratory biomarker analysis and pharmacogenomic studies in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 3 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 50 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 2 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Safety profile of six different administration schedules of RO4929097 (time frame: Up to 4 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 2 Apr 2014.