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Clear Cell Renal Cell CarcinomaPhase 2NCT02607553

Safety and Activity of G-202 in Patients With Clear Cell Renal Cell Carcinoma That Expresses PSMA

A Phase 2 study testing G-202 in people with Clear Cell Renal Cell Carcinoma, run by GenSpera, Inc. at 1 site 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

An open-label, single-arm, single-center Phase II study to evaluate the safety and activity of G-202 in patients with clear cell renal cell carcinoma that expresses PSMA Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Cell Carcinoma
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
2 participants
Where
1 siteUnited States
Study dates
Jun 2016to Feb 2017
Phase
Phase 2
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

  • Male or female patients age ≥ 18 years
  • Pathologic documentation of clear cell renal cell carcinoma
  • Disease that is resistant or refractory to standard of care
  • ECOG Performance Status < 2
  • Most recent tissue biopsy demonstrates PSMA expression by immunohistochemical staining
  • Adequate bone marrow function measured within 7 days prior to first infusion of G-202 (absolute peripheral granulocyte count > 1500 cells/m3; platelet count > 100,000 cells/m3)
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  • Adequate hepatic function measured within 7 days prior to first infusion of G-202 (Albumin ≥ 2.8 g/dL; AST and ALT ≤ 5 x ULN; Total bilirubin <2 mg/dL)
  • Adequate renal function measured within 7 days prior to first infusion of G-202 (Proteinuria level ≤ 2 by urine dipstick; Serum creatinine ≤1.5 x ULN)
  • Normal coagulation profile measured within 14 days prior to first infusion of G-202 (INR ≤ 2.3; aPTT ≤ 1.5 X ULN)
  • No history of substantial non-iatrogenic bleeding diatheses. Use of anti-coagulants is limited to local use only (for control of central line patency)
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study and are willing to participate in the study
  • Females of child-bearing potential and males with female partners of child-bearing potential must be willing to use acceptable methods of contraception to avoid pregnancy (for example, oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) beginning before the first infusion of G-202 and for 3 months after the last infusion of G-202

Who cannot join

  • Uncontrolled cardiac, hepatic, renal, or neurologic/psychiatric disorder
  • HIV positivity or history of chronic hepatitis B or C infection
  • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a 2D echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months of enrollment demonstrates a left ventricular ejection fraction >45%
  • History of another malignancy within the previous 5 years other than curatively treated non-melanoma skin cancer or or intraepithelial carcinoma of the cervix
  • Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1 week of first G-202 treatment
  • Treatment, chemotherapy, radiation therapy, immunotherapy, or investigational drug for the patient's renal cell cancer within 28 days prior to first infusion of G-202
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  • Currently requiring systemic administration of antibiotics or chronic administration of anti-viral agents
  • Use of anti-coagulants is limited to local use for control of central line patency
  • History or evidence of cardiac risk, including corrected QT interval on screening ECG > 470 msec, clinically significant uncontrolled arrhythmias or arrhythmia requiring treatment with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia, history of acute coronary syndromes within 6 months prior to the first dose of study therapy (including myocardial infarction and unstable angina, coronary artery bypass graft, angioplasty, or stenting), any history of congestive heart failure with most recent ejection fraction < 45%
  • Uncontrolled cardiac or coronary artery disease
  • Uncontrolled hypertension (mean systolic BP ≥ 160 mm Hg and/or mean diastolic BP ≥ 100 mm Hg on 3 determinations 5 minutes apart while on 2 anti-hypertensive agents) or hypertension requiring treatment with more than 2 anti-hypertensive agents.
  • Severe or uncontrolled medical disease, including uncontrolled diabetes, congestive heart failure, chronic renal disease or chronic pulmonary disease
  • Severe gastrointestinal bleeding within 12 weeks of treatment with G-202
  • Requirement for chronic use of medications known to be strong inhibitors or inducers of cytochrome (CYP3A4) iso-enzymes (Appendix 3) Note: If patients can stop receiving these medications, CYP3A4 inhibitors should be discontinued at least 7 days prior to starting treatment with G-202
  • Known hypersensitivity to any study drug component including thapsigargin derivatives, polysorbate 20, or propylene glycol
  • Any other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirements

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Health Science Center, Houston

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: G-202-006: An Open-Label, Single-Arm, Phase II Study to Evaluate the Safety and Activity of G-202 in Patients With Clear Cell Renal Cell Carcinoma That Expresses PSMA

An open-label, single-arm, single-center Phase II study to evaluate the safety and activity of G-202 in patients with clear cell renal cell carcinoma that expresses PSMA

Read the detailed description

Epithelial tumors, including clear cell renal cell carcinoma (RCC), have the ability to grow to only a finite size in the absence of vascularization. RCC is characterized as a highly-vascularized tumor and inhibiting angiogenesis has the potential to impair tumor growth, including growth of RCC. Therapeutic targeting of integral biological pathways in RCC, including those involving VEGF and mTOR, has produced robust clinical effects and revolutionized the treatment of metastatic RCC. These approaches offers significant clinical benefit and sequential use of these agents has become the empirical standard of care. However, complete or durable responses are uncommon and resistance develops after a median interval of 6-15 months. This raises the pressing clinical need for additional therapeutic approaches for patients with metastatic clear cell RCC. The purpose of this study is to investigate the approach of targeted delivery of cytotoxic chemotherapy with G-202 in patients with advanced, refractory RCC. This study is based on prodrug tumor targeting, in which an inactive form of a toxic agent is administered systemically and gets activated in specific locations in the body, resulting in higher concentrations of the cytotoxic form at the tumor location. G-202 is a prodrug that is activated by PSMA in the blood vessels of tumors, but not normal tissue; once activated, G-202 leads to disruption of intracellular calcium levels and subsequent induction of apoptosis. Thus, G-202 is expected to bring about cell death in RCC and destroy the blood supply of RCC tumors. This single-arm, open-label Phase II clinical trial will evaluate the safety and activity of G-202 in patients with RCC that expresses PSMA.

Being tested
G-202
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • G-202Drug

    Also called Mipsagargin

    G-202 administered by intravenous infusion on Days 1, 2 and 3 of each 28-day cycle until disease progression

Study groups in NCT02607553
Study groupRoleWhat they receive
Experimental: G-202ExperimentalG-202 administered by intravenous infusion on 3 consecutive days of a 28-day cycle
Receives: Drug: G-202

What is being measured

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

  1. Clinical activity

    Use RECIST criteria to assess the clinical activity of G-202 administered by intravenous infusion daily for 3 consecutive days of a 28-day cycle

    Measured: 8 weeks from first administration of G-202

Timeline

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

  1. First posted18 Nov 2015 (estimated)
  2. Study startJun 2016
  3. Primary completionDec 2016
  4. Study completionFeb 2017

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02607553
Sponsor's protocol ID
G-202-006
Status last verified
Feb 2017
First submitted
16 Nov 2015
Last updated
24 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing G-202 in people with Clear Cell Renal Cell Carcinoma, run by GenSpera, Inc. at 1 site 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 12 inclusion and 16 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Clinical activity (time frame: 8 weeks from first administration of G-202). 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 NCT02607553.

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 24 Feb 2017.

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