Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00024206
SU6668 in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing orantinib, laboratory biomarker analysis and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced solid tumors. SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor 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?
- orantinib, laboratory biomarker analysis and pharmacological study
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jul 2003
- 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 confirmed advanced solid tumor for which no standard therapy exists
- At least 1 measurable tumor lesion (at least 2 cm) not previously irradiated
- No history of brain metastases
- Negative brain CT/MRI required for patients with signs and symptoms suspicious for brain metastases
- Performance status - ECOG 0-1
- WBC greater than 3,000/mm^3
Show all 38Show fewer
- Absolute neutrophil count greater than 1,500/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 10 g/dL
- No history of bleeding diathesis
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT less than 2.5 times ULN
- Creatinine less than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
- No concurrent uncontrolled medical or psychiatric disorders
- No severe iodine allergy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- At least 30 days since prior over-the-counter, anticancer biologic agents (e.g., shark cartilage)
- No concurrent over-the-counter, anticancer biologic agents (e.g., shark cartilage)
- At least 3 weeks since prior cytotoxic or cytostatic agents (6 weeks for nitrosoureas or mitomycin)
- Patients with ECOG performance status 0:
- Any number of prior chemotherapy regimens allowed
- Patients with ECOG performance status 1:
- No more than 3 prior chemotherapy regimens for metastatic or recurrent disease
- The same drug given on a different schedule does not count as a different regimen
- Prior adjuvant chemotherapy for non-metastatic disease or as part of a concurrent chemoradiotherapy protocol is allowed but does not count as part of the 3-regimen limit
- See Disease Characteristics
- See Chemotherapy
- At least 3 weeks since prior radiotherapy to nonindicator lesions
- No concurrent radiotherapy
- At least 24 hours since prior minor surgery (e.g., central venous catheter placement)
- At least 4 weeks since prior major surgery (e.g., laparotomy, thoracotomy, or craniotomy)
- At least 30 days since prior anticancer herbal remedies
- At least 30 days since prior investigational agents
- No concurrent anticancer herbal remedies
- No other concurrent investigational or anticancer medication
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Surrogate Endpoint Trial of SU6668 in Patients With Incurable Solid Tumors
Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced solid tumors. SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor
Read the detailed description
OBJECTIVES:
- Determine the optimal biologically effective dose of SU6668 in patients with advanced solid tumors.
II. Assess the safety and tolerability of this therapy in these patients. III. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this therapy in these patients.
IV. Determine the extent, frequency, and duration of any tumor responses in patients treated with this therapy.
- Determine a recommended phase II dose of SU6668 for future clinical studies.
OUTLINE: This is a dose-escalation study.
Patients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100% or more.
Cohorts of at least 6 patients receive escalating doses of SU6668 until the optimal biologically effective dose (OBD) is determined. Once the OBD is reached, dose escalation continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
- Being tested
- orantinib, laboratory biomarker analysis, pharmacological study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orantinibDrug
Also called SU006668, SU6668, Sugen SU6668, TSU 68
Given orally
laboratory biomarker analysisOther
Correlative studies
Also called pharmacological studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (orantinib) | Experimental | Patients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100% or more.
Cohorts of at least 6 patients receive escalating doses of SU6668 until the OBD is determined. Once the OBD is reached, dose escalation continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Receives: Drug: orantinib; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events, as defined by the Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) term and body system, graded according to the National Cancer Institute Common Toxicity Criteria v2.0
Measured: Up to 2 years
Maximally tolerated dose of orantinib, graded according to the NCI CTC v2.0
Measured: Up to 4 weeks
Secondary outcomes (2)
Tumor response, assessed using the Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Up to 2 years
Angiogenic surrogate measures in terms of change in cytokines over time
A mixed-effects analysis of variance (ANOVA) model will be used, and a fixed-effects model in which the same polynomial is fit for each patient will be used.
Measured: Days 8, 15, and 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2003 (estimated)
- Study startJul 2001
- Primary completionJul 2003
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Roy Herbst, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00024206
- Sponsor's protocol ID
- NCI-2012-02412
- Other IDs
- ID00-184, U01CA062461, CDR0000068900
- Status last verified
- Jan 2013
- First submitted
- 13 Sep 2001
- Last updated
- 23 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Surrogate Endpoint Trial of SU6668 in Patients With Incurable Solid Tumors
- ClinicalTrials.gov ID
- NCT00024206
- Acronym / sponsor ID
- NCI-2012-02412
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2001
- Primary completion
- Jul 2003 (actual)
- First posted
- 21 Oct 2003 (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.
Phase I trial to study the effectiveness of SU6668 in treating patients who have advanced solid tumors. SU6668 may stop the growth of solid tumors by stopping blood flow to the tumor
Detailed description
OBJECTIVES:
- Determine the optimal biologically effective dose of SU6668 in patients with advanced solid tumors.
II. Assess the safety and tolerability of this therapy in these patients. III. Determine the pharmacokinetic profile and interpatient pharmacologic variability of this therapy in these patients.
IV. Determine the extent, frequency, and duration of any tumor responses in patients treated with this therapy.
- Determine a recommended phase II dose of SU6668 for future clinical studies.
OUTLINE: This is a dose-escalation study.
Patients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100% or more.
Cohorts of at least 6 patients receive escalating doses of SU6668 until the optimal biologically effective dose (OBD) is determined. Once the OBD is reached, dose escalation continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (orantinib) | Experimental | Drug: orantinib, Other: laboratory biomarker analysis, Other: pharmacological studyPatients receive oral SU6668 twice daily on days 1-28. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression of 100% or more. Cohorts of at least 6 patients receive escalating doses of SU6668 until the OBD is determined. Once the OBD is reached, dose escalation continues until the maximum tolerated dose (MTD) is determined (if possible). The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Histologically confirmed advanced solid tumor for which no standard therapy exists
- At least 1 measurable tumor lesion (at least 2 cm) not previously irradiated
- No history of brain metastases
- Performance status - ECOG 0-1
- WBC greater than 3,000/mm^3
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 |
|---|---|---|
| orantinibAlso: SU006668, SU6668, Sugen SU6668, TSU 68Given orally | Drug | Treatment (orantinib) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (orantinib) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (orantinib) |
Primary outcome
Incidence of adverse events, as defined by the Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) term and body system, graded according to the National Cancer Institute Common Toxicity Criteria v2.0
Time frame: Up to 2 years
Maximally tolerated dose of orantinib, graded according to the NCI CTC v2.0
Time frame: Up to 4 weeks
2 secondary outcomes
Tumor response, assessed using the Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 2 years
Angiogenic surrogate measures in terms of change in cytokines over time
Time frame: Days 8, 15, and 22
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 23 Jan 2013.
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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.
Roy Herbst principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing orantinib, laboratory biomarker analysis and pharmacological study in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site 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 38 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Incidence of adverse events, as defined by the Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) term and body system, graded according to the National Cancer Institute Common Toxicity Criteria v2.0 (time frame: Up to 2 years). 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?
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 23 Jan 2013; AzTrials last refreshed its copy on 30 Oct 2026.