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Closed (no longer recruiting)Last updated: 14 May 2024

This phase I trial is evaluating an intravenous drug (PTX-100) in people with an advanced cancerPhase 1 Pharmacodynamic and Pharmacokinetic Study of the Geranylgeranyltransferase I Inhibitor PTX-100 (GGTI-2418) in Patients With Advanced Malignancies

Clinical summary

Summary

This is a single arm study, in which eligible patients will receive intravenous PTX-100 for a duration of 60 minutes on Days 1-5 in a 14 day cycle, for 4 cycles.

Conditions

This trial is treating patients with multiple myeloma, peripheral T-cell lymphoma, pancreas cancer and diffuse gastric cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Prescient Therapeutics, Ltd.

Scientific Title

Phase 1 Pharmacodynamic and Pharmacokinetic Study of the Geranylgeranyltransferase I Inhibitor PTX-100 (GGTI-2418) in Patients With Advanced Malignancies

Eligibility

Inclusion

  1. Biopsy proven multiple myeloma (MM), peripheral T-cell lymphoma (CTCL, AITL or PTCL-NOS), colo-rectal cancer (CRC), pancreas cancer (PANC), or diffuse gastric cancer (DGC)
  2. Must have a relapsed or refractory advanced malignancy for which no standard therapy exists.
  3. Must have at least 6 unstained slides of archived formalin-fixed, paraffin-embedded tumor tissue available for genotyping studies; if insufficient or no archived tissue is available, a fresh tumor biopsy within 30 days prior to Cycle 1/Day 1 is mandatory.
  4. Age ≥ 18 years
  5. ECOG performance status ≤ 2
  6. Adequate hematological function: absolute neutrophil count (ANC) ≥ 1000/mm3, platelet count ≥ 50,000 mm3
  7. Adequate hepatic function: total bilirubin ≤ 1.5 times the upper limit of normal (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (patients with liver metastases may be enrolled with elevated hepatic function based on Medical Monitor and Investigator review and agreement)
  8. Adequate renal function: measured, calculated or estimated creatinine clearance of ≥ 50 mL/min
  9. Female patients of childbearing potential must have a negative serum pregnancy test at screening and agree to use dual methods of contraception. Male patients must use an effective barrier method of contraception if sexually active with a female of childbearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or postmenopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for 3 months following the last dose.
  10. Informed consent (current IRB approved version) must be obtained from the patient or legally authorized representative prior to any study-related procedures.

Exclusion

  1. Radiation, chemotherapy, immunotherapy, or any other approved anticancer therapy ≤ 2 weeks prior to study treatment
  2. Participation in another interventional investigational drug study within 4 weeks prior to enrollment
  3. Concurrent radiation, chemotherapy, immunotherapy, or any other approved or investigational anticancer therapeutic (Patients are allowed to receive ≤ 10 mg/day corticosteroids for the treatment of non malignant disorders.)
  4. Myocardial infarction within 6 months before screening, New York Heart Association Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  5. Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose (Patients with controlled infection or on prophylactic antibiotics are permitted in the study.)
  6. Known to be HIV seropositive
  7. Known active hepatitis A, B, or C infection or known to be positive for HCV RNA or HBsAg (HBV surface antigen)
  8. Grade > 2 peripheral neuropathy at screening
  9. Previous allogeneic transplant within the past 6 months or evidence of clinically significant graft-versus-host disease (if prior bone marrow transplant)
  10. Any history of malignancy, other than that treated in this study, unless the patient has remained free of the disease for over 3 years (except for properly treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast)
  11. Any active medical or psychiatric illness that, in the judgement of the investigator, may interfere with adherence to the protocol
  12. Any malignancy with CNS involvement
  13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to PTX-100
  14. Female patients who are pregnant or lactating

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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