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Advanced Solid TumorsPhase 1NCT01056029

Dose-Escalation Phase 1 Study of G-202 (Mipsagargin) in Patients With Advanced Solid Tumors

A Phase 1 study testing G-202 in people with Advanced Solid Tumors, run by GenSpera, Inc. at 3 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

This is an open-label, single-arm, dose-escalation Phase I study to determine the maximum tolerated dose (MTD) of G-202 (mipsagargin) when administered once daily for 3 consecutive days of a 28-day cycle 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
Advanced Solid Tumors
What is being tested?
G-202
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesUnited States
Study dates
Jan 2010to Aug 2013
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

  • Histologically-confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
  • Disease that is measurable and/ or evaluable by RECIST criteria. Patients with prostate cancer require presence of disease on bone scan and/or CT scan and evidence of increasing PSA after standard hormonal therapy
  • ECOG Performance Status ≤ 2
  • Life expectancy estimated to be at least 3 months
  • Acceptable liver function:
  • In the absence of disease involvement in the liver and if bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be ≤ 2 times ULN
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  • In the presence of disease involvement in the liver and if bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be ≤ 5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN Patients with bone metastases alkaline phosphatases ≤ 5 times ULN
  • Acceptable renal function:
  • Serum creatinine ≤ 1.5 times ULN, OR
  • Calculated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
  • Acceptable hematologic status:
  • Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
  • Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
  • Hemoglobin ≥ 9 g/dL
  • Urinalysis with no evidence of proteinuria
  • Acceptable coagulation profile (PT or INR, PTT) < 1.5 times ULN
  • At least 4 weeks since prior chemotherapy or surgery, with recovery to Grade 1 or baseline of significant toxicities felt related to prior drug(s)
  • Women of childbearing potential must have a negative serum pregnancy test at screening.
  • All patients (males and females) of child-bearing potential must agree to use an effective method of birth control
  • Ability to understand and willingness to sign a written informed consent document
  • Patients with prostate cancer must continue androgen deprivation therapy with LHRH agonists

Who cannot join

  • Documentation of keratosis follicularis, also known as Darier or Darier-White disease
  • Known hypersensitivity to any study drug component, including thapsigargin derivatives, Polysorbate 20, or propylene glycol
  • Patients with known and untreated brain metastases. Patients with brain metastases that have been treated and demonstrated to be clinically stable for at least 30 days may be enrolled onto the study
  • Patients with a family history of coagulopathy or patients with DVT or pulmonary embolus within the last 6 months
  • Patients taking anti-coagulants that include Coumadin or low molecular weight heparin
  • Patients with pre-existing cardiac conditions:
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  • Prior documented myocardial infarction within the last 6 months
  • Pre-existing cardiac failure (NYHA class III-IV)
  • Atrial fibrillation on anti-coagulants
  • Unstable angina
  • Severe valvulopathy
  • Cardiac angioplasty or stenting within the last 6 months
  • Use or requirement for use of inhibitors or inducers of cytochrome isoenzymes
  • Corrected QTc prolongation value, calculated using Bazett's formula (QTcB = QT/RR ½), > 450 msec
  • Pregnant or lactating females
  • Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study
  • Active uncontrolled infection, including known history of AIDS or hepatitis B or C
  • Any psychological, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule
  • Concurrently receiving any other investigational agents while on study

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • University of Wisconsin Paul P Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • University of Texas, Health Science Center,Cancer Therapy and Research Center

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: An Open Label, Single-Arm, Dose-Escalation Phase 1 Study of G-202 (Mipsagargin) in Patients With Advanced Solid Tumors

This is an open-label, single-arm, dose-escalation Phase I study to determine the maximum tolerated dose (MTD) of G-202 (mipsagargin) when administered once daily for 3 consecutive days of a 28-day cycle in patients with advanced solid tumors. G-202 will be administered by intravenous infusion over 1 hour on Days 1, 2 and 3 of each 28-day cycle.

Read the detailed description

Pro-drug chemotherapy is an approach to cancer treatment that is being investigated as a means to achieve higher concentrations of cytotoxic or biologically active agents at a tumor location while avoiding systemic toxicity. With pro-drug chemotherapy, a relatively non-toxic form of a cytotoxin, the pro-drug, is converted into the active cytotoxic agent at the tumor site or other specific location. G-202 (mipsagargin) is a thapsigargin pro-drug; it consists of a cytotoxic analog of thapsigargin coupled to a masking peptide which inhibits its biologic activity until proteolytic cleavage at the tumor site. Thapsigargin is a natural product with profound effects on cell viability. Thapsigargin is a non-cell-type specific toxin with documented ability to kill a broad spectrum of cancer cell lines as well as normal endothelial cells, fibroblasts and osteoblasts. It induces a rapid and pronounced increase in the concentration of cytosolic calcium, due to blockade of the Sarcoplasmic/Endoplasmic Reticulum Calcium ATPase (SERCA) pump to which it binds with high affinity. The increase in cytosolic calcium leads to induction of apoptosis and ensuing cell death.

The anti-tumor effect of G-202 in humans with advanced solid tumors is not yet known.

Being tested
G-202
Keywords
Solid Tumors

What participants receive

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

  • G-202Drug

    Thapsigargin is Pro-drug chemotherapy which will be administered by intravenous infusion over 1 hour on Days, 1, 2 and 3 of each 28 day cycle

Study groups in NCT01056029
Study groupRoleWhat they receive
G-202ExperimentalNot described
Receives: Drug: G-202

What is being measured

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

  1. Determine the MTD and DLT(s) of G-202 administered by intravenous infusion daily for 3 consecutive days on a 28-day cycle in patients with advanced solid tumors.

    Measured: 2 years

  2. Establish the recommended dose of G-202 to be used in Phase II studies.

    Measured: 2 years

  3. Determine the pharmacokinetics of G-202 administered by intravenous infusion daily for 3 consecutive days on a 28-day cycle in patients with advanced solid tumors.

    Measured: 2 years

Secondary outcomes (2)

  1. Investigate the safety profile of G-202 administered by intravenous infusion daily for 3 consecutive days on a 28-day cycle in patients with advanced solid tumors.

    Measured: 2 years

  2. Document any evidence of anti-tumor activity, including response rate, disease stability, progression-free or overall survival, in response to G-202 administration

    Measured: 2 years

Timeline

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

  1. First posted26 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2012
  4. Study completionAug 2013

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
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01056029
Sponsor's protocol ID
G-202-001
Status last verified
Dec 2015
First submitted
25 Jan 2010
Last updated
10 Dec 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing G-202 in people with Advanced Solid Tumors, run by GenSpera, Inc. at 3 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 22 inclusion and 19 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Determine the MTD and DLT(s) of G-202 administered by intravenous infusion daily for 3 consecutive days on a 28-day cycle in patients with advanced solid tumors. (time frame: 2 years). 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 NCT01056029.

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 10 Dec 2015.

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