Solid Tumors Using Ixabepilone and Dasatinib

NCT00717704 | Completed Phase 1 DMC

• 1 other identifier: WCI-2007-528
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Patients are being asked to take part in this study because they have been diagnosed with an advanced solid tumor that is not responding to standard treatments. This study will find the highest dose of ixabepilone and dasatinib in combination that can be given without causing severe side effects. Both ixabepilone and dasatinib have individually been tested in many (several thousand) patients, however the combination of the two drugs has not yet been tested in humans. All patients who will take part in this study will receive combined drug therapy of dasatinib and ixabepilone. Dasatinib is a pill that is taken by mouth. Ixabepilone is a medicine that will be given by vein (IV). All participants will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily.

Conditions

Solid Tumor

Keywords

Malignant solid tumor; Phase 1; Dose escalation; Metastatic or locally advanced/unresectable; Disease progression through standard therapy

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to determine the safety and toxicity of ixabepilone and dasatinib in combination in patients with metastatic or locally advanced/unresectable solid tumors that have progressed through standard therapy.

  While on the drug combination, patients will be seen in the clinic every 3 weeks. These visits will assess the safety and tolerablility of the drug regimen. The drug combination continues until disease progression or unacceptable toxicity. When one of those two events occurs, the patient enters the followup phase. During the followup phase, the patient will return to the clinic every 4 weeks until drug-related toxicities resolve.

  From study start until completion of study followup. This can vary greatly between patients, but on average patients received treatment for 4 cycles (12 weeks).

Secondary Outcomes (1)

• The secondary outcome is to evaluate tumor response as a preliminary assessment of clinical activity.

  From start of the study until completion of the drug regimen. This can vary greatly between patients, but on average patients received treatment for 4 cycles (12 weeks).

Study Arms (1)

1

EXPERIMENTAL

All participants will receive ixabepilone by vein once every three weeks as well as dasatinib by mouth once daily. All participants will receive the study drugs at a baseline dose. If the side effects are minimal and tolerable, the next cycle of study drugs will be given at same dosage. If side effects are intolerable, then the dose will be lowered.

Drug: ixabepilone; Drug: Dasatinib

Interventions

ixabepilone DRUG

by vein once every 3 weeks

Also known as: ixempra

1

Dasatinib DRUG

by mouth once daily

Also known as: Sprycel, BMS-354825

1

Eligibility Criteria

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

You may qualify if:

• Have a solid tumor malignancy that is metastatic or locally advanced/unresectable
• Progression through standard therapy
• Histological documentation of cancer
• Must be off prior chemotherapy or radiation therapy for at least 3 weeks
• Must have adequate organ and marrow function prior to the start of study treatment as defined by the protocol
• Must be able to swallow oral medication (dasatinib must be swallowed whole)
• Must be available for protocol-required follow-up

You may not qualify if:

• Patients with a malignancy (other than the one treated in this study) which required radiotherapy or systemic therapy within the past 5 years
• Symptomatic brain metastasis that is either untreated or uncontrolled by surgery and or radiotherapy
• A known, prior, severe (NCI CTC Grade 3/Grade 4) history of hypersensitivity reaction to a drug formulated in Cremophor (polyoxyethylated castor oil)
• A serious, uncontrolled medical disorder or active infection including pericardial or pleural effusion of any grade,uncontrolled or significant cardiovascular disease,a bleeding disorder.

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

ixabepilone; Dasatinib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Sandra M Swain, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 15, 2008
• First Posted: July 17, 2008
• Study Start: July 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 5, 2020

Record last verified: 2012-05

Locations

US (1)