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Advanced or Metastatic Solid TumorsPhase 1SF112600106NCT00907205

A Dose Escalation Study of SF1126, a PI3 Kinase (PI3K) Inhibitor, Given By Intravenous (IV) Infusion in Patients With Solid Tumors

A Phase 1 study testing SF1126 in people with Advanced or Metastatic Solid Tumors and Cancer, run by Semafore Pharmaceuticals at 4 sites in United States.

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 evaluate the safety and tolerability of SF1126 in patients with advanced or metastatic tumors by assessing the dose limiting toxicities (DLTs) and defining the maximum tolerated dose given twice per week for 4 weeks and ultimately define a recommended phase II dose. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SF1126
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
4 sitesUnited States
Study dates
Apr 2007to Apr 2011
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

  • To qualify for enrollment, all of the following criteria must be met:
  • Written informed consent.
  • At least 18 years old.
  • Accrual will be limited to patients with tumor types that in the opinion of the investigator is known to have PTEN loss or PI3 Kinase mutations potentially important in the biology of their cancer.
  • Only patients with histologically confirmation of advanced solid malignant tumor which is refractory to standard therapies or which no standard therapy exists.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1.
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  • Life expectancy of > or = 12 weeks.
  • Female subjects are eligible to enter and participate in the study if: they are non-childbearing potential, had a hysterectomy, had a bilateral oophorectomy (ovariectomy), had a bilateral tubal ligation, post-menopausal or childbearing potential with a negative serum pregnancy test at screening and agrees to protection by IUD, vasectomized partner, complete abstinence, double barrier contraception.
  • male patients with childbearing potential must agree to use adequate contraception while on study.
  • patients on active therapy with well-controlled diabetes as defined by fasting glucose < 160mg/dL.

Who cannot join

  • Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before entry, and stable without steroid treatment for at least 4 weeks.
  • Inadequate bone marrow reserve as demonstrated by an absolute neutrophil count <1.5 x 10^9/L or platelet count < 100 x 10^9/L (can not be post-transfusion) or hemoglobin <9 g/dL (can be post-transfusion).
  • Serum bilirubin > or = 1.2 times the upper limit of normal.
  • An ALT or AST level > or = 2.5 times the upper limit of normal. If documented liver metastases are present, the ALT or AST levels must still be less than 2.5 times the upper limit of normal.
  • Serum creatinine > 1.5 times the upper limit of normal or a creatinine clearance of < or = 50mL/min calculated by the Cockcroft-Gault equation.
  • Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, cardiac [including life threatening arrhythmias], hepatic, or renal disease.
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  • Unresolved toxicity ≥CTC Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
  • QTc prolongation defined as a QTc >450 ms for males or >470ms for females (Fridericia) for 3 consecutive ECGs; OR prior history of cardiovascular disease including heart failure that meets New York Hearth Association (NYHA) class III and IV definitions, OR history of myocardial infarction/active ischemic heart disease within one year of study entry; OR uncontrolled dysrhythmias; OR poorly controlled angina.
  • Participation in a trial of an investigational agent within the prior 30 days.
  • Pregnant or breast-feeding females.
  • High volume peritoneal or pleural effusions requiring a tap more frequently than every 14 days.
  • History of other malignancies except curatively excised carcinoma in situ of the cervix, non-melanomatous skin carcinoma or superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for > or = 5 years. Other cases will be reviewed and possibly allowed if discussed with and approved by Medical Monitor.
  • Patients receiving therapeutic doses of Warfarin.
  • Any concurrent condition which in the investigator's opinion makes it undesirable for the subject to participate in this trial or which would jeopardize compliance with the protocol.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Scottsdale Clinical Research Institute

    Scottsdale, Arizona, 85258

  • Arizona Cancer Center

    Tucson, Arizona, 85719

Other trials in United States

About this study

Official title: A Phase I Open Label Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation Study of SF1126, A PI3 Kinase (PI3K) Inhibitor, Given Twice Weekly By IV Infusion To Patients With Advanced or Metastatic Tumors

The purpose of this study is to evaluate the safety and tolerability of SF1126 in patients with advanced or metastatic tumors by assessing the dose limiting toxicities (DLTs) and defining the maximum tolerated dose given twice per week for 4 weeks and ultimately define a recommended phase II dose.

Read the detailed description

SF1126 is a conjugate containing a vascular targeted pan-PI3K inhibitor that selectively inhibits all PI3K class I isoforms and other key members of the PI3K superfamily, including mTORC1/2, DNA-PK, PLK-1, CK2, ATM and PIM-1. SF1126 is designed to inhibit both angiogenesis and cell proliferation by targeting and binding to specific integrins such as αγβ3 that are expressed on the surface of new tumor vasculature and within the tumor compartment. In preclinical xenograft models SF1126 has demonstrated broad activity as a single agent; synergy with commonly used chemotherapy agents, targeted agents, and radiation; and has been shown to reverse resistance mediated through the PI3K/PTEN pathway.

Being tested
SF1126
Keywords
Advanced Solid Tumors, Metastatic Solid Tumors, PI3K, PI3K Inhibitors, PI3 Kinase Inhibitors, mTORC inhibitor, mTORC1 inhibitor, mTORC2 inhibitor, vascular targeted, conjugate
Medical subject headings
Neoplasms

What participants receive

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

  • SF1126Drug

    Dose Escalating with 3+ patients in each cohort

Study groups in NCT00907205
Study groupRoleWhat they receive
SF1126ExperimentalTwice weekly IV infusion
Receives: Drug: SF1126

What is being measured

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

  1. To assess the dose limiting toxicities (DLTs) of SF1126 and the maximum tolerated dose given twice per week for 4 weeks and ultimately define a recommended phase II dose.

    Measured: Assessed at each visit and end of cycle 1

Secondary outcomes (2)

  1. To assess any preliminary evidence of anti-tumor activity observed with SF1126

    Measured: Through study completion or early study discontinuation

  2. To characterize the pharmacokinetics following the IV doses on Days 1 and 28

    Measured: Cycle 1 Days 1 and 28

Timeline

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

  1. First posted22 May 2009 (estimated)
  2. Study startApr 2007
  3. Primary completionJan 2011
  4. Study completionApr 2011

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00907205
Sponsor's protocol ID
SF1126-001-06
Acronym
SF112600106
Status last verified
Jun 2013
First submitted
20 May 2009
Last updated
13 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

  • Mahadevan D, Chiorean EG, Harris WB, Von Hoff DD, Stejskal-Barnett A, Qi W, Anthony SP, Younger AE, Rensvold DM, Cordova F, Shelton CF, Becker MD, Garlich JR, Durden DL, Ramanathan RK. Phase I pharmacokinetic and pharmacodynamic study of the pan-PI3K/mTORC vascular targeted pro-drug SF1126 in patients with advanced solid tumours and B-cell malignancies. Eur J Cancer. 2012 Dec;48(18):3319-27. doi: 10.1016/j.ejca.2012.06.027. Epub 2012 Aug 23.

    PubMed 22921184

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SF1126 in people with Advanced or Metastatic Solid Tumors and Cancer, run by Semafore Pharmaceuticals at 4 sites 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 10 inclusion and 14 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 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

To assess the dose limiting toxicities (DLTs) of SF1126 and the maximum tolerated dose given twice per week for 4 weeks and ultimately define a recommended phase II dose. (time frame: Assessed at each visit and end of cycle 1). 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 NCT00907205, which also lists 1 linked publication.

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 13 Jun 2013.

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