SU6668 in Treating Patients With Advanced Solid Tumors

NCT00024206 | Completed Phase 1

• 4 other identifiers: NCI-2012-02412ID00-184U01CA062461CDR0000068900
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

• 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

  Up to 2 years

• Maximally tolerated dose of orantinib, graded according to the NCI CTC v2.0

  Up to 4 weeks

Secondary Outcomes (2)

• Tumor response, assessed using the Response Evaluation Criteria in Solid Tumors (RECIST)

  Up to 2 years

• Angiogenic surrogate measures in terms of change in cytokines over time

  Days 8, 15, and 22

Study Arms (1)

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.

Drug: orantinib; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

orantinib DRUG

Given orally

Also known as: SU006668, SU6668, Sugen SU6668, TSU 68

Treatment (orantinib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (orantinib)

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Treatment (orantinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

orantinib

Study Officials

• Roy Herbst

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: October 21, 2003
• Study Start: July 1, 2001
• Primary Completion: July 1, 2003
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (1)