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TumorsPhase 1NCT00395434

Safety Study of Increasing Doses of Combretastatin in Combination With Bevacizumab (Avastin) in Patients With Advanced Solid Tumors

A Phase 1 study testing Combretastatin A4 Phosphate (CA4P) and Bevacizumab (Avastin) in people with Tumors, run by Mateon Therapeutics at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety and tolerability of three dose levels of combretastatin A4 phosphate (CA4P) given intravenously (IV) in combination with bevacizumab every 14 days in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors
What is being tested?
Combretastatin A4 Phosphate (CA4P) and Bevacizumab (Avastin)
How many people
20 participants
Where
2 sitesUnited Kingdom
Study dates
Sep 2006to Jan 2007
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

  • Histopathologically or cytologically confirmed malignant solid tumors that have failed standard therapy or for which no life prolonging treatment exists
  • Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • At least 4 weeks since any prior immunotherapy, chemotherapy or radiation therapy prior to first dose of study drug (six weeks for therapy known to be associated with delayed toxicity such as nitrosoureas or mitomycin-C)
  • Age > or = to 18 years old
  • Adequate bone marrow function:
  • absolute granulocyte count (neutrophils and bands) > or = to 1500 cells/mm3;
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  • platelet count > or = to 100,000 cells/mm3;
  • hemoglobin > or = to 9 g/dL.
  • Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance > or = to 50 mL/minute)
  • Adequate hepatic function:
  • bilirubin less than or = to 1.5 mg/dL;
  • aspartate transaminase (AST) and alanine transaminase (ALT) less than or = to 2.5 times the institutional upper limit of normal (ULN) (or less than or = to 5 times ULN if liver metastases are present).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy of > or = to 12 weeks
  • Written, signed, dated, and witnessed (if applicable as per International Conference on Harmonization [ICH] guidelines) Independent Ethics Committee (IEC) approved informed consent form before any study specific screening procedures are performed
  • Fertile subjects must abstain from sexual intercourse or use effective birth control.
  • All women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours of first dose.

Who cannot join

  • Contraindications, allergies or sensitivity to the use of the study medications or any other products required for participation in this study (i.e. contrast agents)
  • Presence of central nervous system (CNS) metastases
  • Diagnosed squamous non-small cell lung cancer (NSCLC)
  • History of gastrointestinal perforations
  • Surgery within 28 days of screening visit or a surgical incision that is not fully healed. Any surgery planned during the study period.
  • Proteinuria >1 g/24 hours by 24 hour urine collection (perform 24 hour urine collection if > 1+ on dipstick)
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  • Recent hemoptysis (occurrence within the past 3 months)
  • Prior therapy with CA4P or bevacizumab, or other agents which target vascular endothelial growth factor (VEGF) or VEGFR signaling such as Sorafenib and Sutent
  • Prior radiation involving > 30% of the bone marrow
  • Radical radiotherapy to the thorax or abdomen at any time or post-operative radical radiotherapy to the pelvis. Palliative radiotherapy treatments are acceptable. Subjects with rectal primaries who have received pre-operative pelvic radiotherapy or chemoradiation are eligible if the small bowel was mobile and not stuck to the tumor.
  • Active autoimmune disorder(s)
  • Immunocompromised, including subjects known to be human immunodeficiency virus (HIV) positive
  • Active infection requiring antibiotic therapy or any other serious intercurrent illness
  • History of angina (stable or severe, even if controlled with medications), myocardial infarction, congestive heart failure (CHF), non-controlled atrial arrhythmias or clinically significant arrhythmias including conduction abnormality, nodal junctional arrhythmias and dysrhythmias, sinus bradycardia or tachycardia, supraventricular arrhythmias, atrial fibrillation or flutter, syncope or vasovagal episodes
  • Electrocardiogram (ECG) with evidence of prior myocardial infarction (e.g., significant Q waves), QTc > 450 msec or other clinically significant abnormalities
  • Taking any drug(s) known to prolong the QTc interval, which cannot be interrupted for at least four days during each treatment cycle.
  • Known significant heart wall abnormality or heart muscle damage as evidenced on multiple-gated acquisition (MUGA) scan or echocardiogram (this is not a required screening investigation)
  • Uncontrolled hypertension (defined as blood pressure consistently greater than 150/100 irrespective of medication). Or controlled hypertension requiring use of > 2 classes of anti-hypertensives.
  • Uncontrolled hypokalemia and/or hypomagnesemia
  • Symptomatic peripheral vascular disease or cerebrovascular disease
  • Psychiatric disorders or other conditions rendering subjects incapable of complying with the requirements of the protocol
  • Receiving concurrent hormonal therapy with the exception of gonadotropin-releasing hormone (GnRH) agonists in subjects with hormone refractory prostate cancer, hormone replacement therapy (HRT), oral contraceptives, and megestrol acetate used for anorexia/cachexia
  • Receiving anticoagulation with warfarin, heparin or low molecular weight heparin other than low dose (1 mg) warfarin for maintenance of central line patency
  • Women who are currently pregnant, nursing, or planning a pregnancy; or women who have a positive pregnancy test.
  • Receiving concurrent antineoplastic therapy (radiation therapy, cytotoxic or biologic therapy)
  • Participation in an investigational drug or device trial within 30 days of entering the study.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Mount Vernon Hospital

    Northwood, Middlesex, HA6 2RN

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: OXC4P1-105: A Phase I Study of the Safety, Tolerability, and Antitumor Activity of Escalating Doses of Combretastatin A4 Phosphate Given in Combination With Bevacizumab to Subjects With Advanced Solid Tumors

The purpose of this study is to determine the safety and tolerability of three dose levels of combretastatin A4 phosphate (CA4P) given intravenously (IV) in combination with bevacizumab every 14 days in patients with advanced solid tumors. The maximum tolerated dose will be defined if it is at one of the three dose levels under study.

Conditions
Tumors
Being tested
Combretastatin A4 Phosphate (CA4P), Bevacizumab (Avastin)
Keywords
Advanced Solid Tumors, Advanced Solid Tumours, Advanced Solid Tumor, Advanced Solid Tumour, Advanced, Malignant, Solid, Tumors, Tumours, Tumor, Tumour, Cancer, Malignant Solid Tumors, Malignant Solid Tumours, Malignant Solid Tumor, Malignant Solid Tumour, Metastatic Cancer, Metastatic Disease, Advanced Cancer, Vascular Disrupting Agent
Medical subject headings
Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combretastatin A4 Phosphate (CA4P)Drug

  • Bevacizumab (Avastin)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety and tolerability of the combination therapy assessed by analysis of adverse events

  2. safety and tolerability of the combination therapy assessed by analysis of laboratory tests

  3. safety and tolerability of the combination therapy assessed by analysis of other assessments within the protocol

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionJan 2007
  4. Study completionJan 2007

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00395434
Sponsor's protocol ID
OXC4P1-105
Status last verified
Oct 2011
First submitted
1 Nov 2006
Last updated
31 Oct 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Combretastatin A4 Phosphate (CA4P) and Bevacizumab (Avastin) in people with Tumors, run by Mateon Therapeutics at 2 sites in United Kingdom.

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 17 inclusion and 26 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 31 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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 and tolerability of the combination therapy assessed by analysis of adverse events. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00395434.

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 31 Oct 2011.

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