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New drug cocktail trial aims to tame advanced cancers

NCT ID NCT01187199

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests the safety and best dose of combining two drugs (bevacizumab and temsirolimus) with one of three other cancer drugs for people with advanced cancer that hasn't responded to standard treatments. About 278 participants will receive one of the combinations to find the highest tolerable dose. The goal is to control the disease, not cure it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 278 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2010

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Inclusion: (For all treatment arms) 2. 1.1 Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months. 3. 1.2 Patients must have been off previous chemotherapy or radiotherapy for the three weeks prior to entering this study. Six weeks will be required if the patient has received therapy which is known to have delayed toxicity (mitomycin or a nitrosurea). Five half-lives will be required for biologic/targeted therapies with short (\<24 hour) half-lives and pharmacodynamic effects. Patients may have received palliative radiation immediately before (or during) treatment provided radiation does not target the only measurable or evaluable disease. 4. 1.3 Patients must have measurable or evaluable disease 5. 1.4 ECOG performance status \</= 2 (Karnofsky \>/= 60%, Lansky \>/= 50%). 6. 1.5 Patients must have normal organ function defined as: creatinine \</= 1.5 x ULN for children and \</= 2.0 x ULN for adults; total bilirubin \</= 2.0; ALT(SGPT)/AST (SGOT) \</= 5 X ULN. In patients with significant liver disease and chronically elevated liver transaminases, ALT/AST may be elevated as high as 8 X ULN. 7. 1.6 Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose. 8. 1.7 Ability to understand and the willingness to sign a written informed consent document. 9. 1.8 Life expectancy of at least 3 months. 10. 1.9 Patients may not be receiving any other experimental agents and/or any other concurrent anticancer agents or therapies except hormonal maintenance. 11. Inclusion: (For carboplatin and paclitaxel arms) 12. 2.1 Patients must have normal marrow function defined as: absolute neutrophil count \>/= 1,500/mL; platelets \>/= 100,000/mL. 13. 2.2 Patient with neuropathies of CTC grade 1 or less. 14. Inclusion: (For sorafenib arm) 15. 3.1 Patients must have normal marrow function defined as: absolute neutrophil count \>/= 1,000/mL; platelets \>/= 75,000/mL. Exclusion Criteria: 1. Exclusion: (For all treatment arms) 2. 4.1 Patients with clinically significant unexplained bleeding within 28 days prior to entering the study. 3. 4.2 Uncontrolled systemic vascular hypertension (Systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg on medication). 4. 4.3 Patients with clinically significant cardiovascular disease: History of CVA within 6 months Myocardial infarction or unstable angina within 6 months Unstable angina pectoris New York Heart Association Class \> II 5. 4.4 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1. 6. 4.5 Pregnant or lactating women. 7. 4.6 History of hypersensitivity to bevacizumab or murine products, temsirolimus or its metabolites, or any component of the formulation. 8. 4.7 Patients with hemorrhagic brain metastases. 9. 4.8 Patients with prior abdominal surgery within 30 days prior to entering the study. 10. 4.9 Medications with potent inducer or inhibitor of P450 3A4 should be avoided within 5 half lives of temsirolimus. 11. Exclusion: (For carboplatin treatment arm) 12. 5.1 Hypersensitivity to carboplatin or any component of the formulation. 13. Exclusion: (For paclitaxel treatment arm) 14. 6.1 Hypersensitivity to paclitaxel or any component of the formulation. 15. Exclusion: (For sorafenib treatment arm) 16. 7.1 History of hypersensitivity to sorafenib or any component of the formulation.

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Conditions

The condition(s) this trial relates to.

cancer Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.