A Phase 2 Biomarker - Enriched Study of TH-302 in Subjects With Advanced Melanoma

NCT01864538 | Terminated Phase 2 Results

• 1 other identifier: TH-CR-413
• Study Type: interventional
• Target: 11
• Locations: 2 countries
• Sites: 7

Brief Summary

The primary objective of this study is to determine the response rate, duration of response,progression-free survival and overall survival of subjects with advanced melanoma treated with TH-302.

Conditions

Metastatic Melanoma

Keywords

TH-302; Advanced Melanoma; Metastatic; Biomarker; Mucosal Melanoma; Evofosfamide

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  1 year

Study Arms (1)

TH-302

EXPERIMENTAL

480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.

Drug: TH-302

Interventions

TH-302 DRUG

480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.

TH-302

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's Regional Ethics Board/Independent Ethics Committee (REB/IEC)
• Histologically documented cutaneous or mucosal malignant melanoma, which is recurrent or metastatic and is not curable by surgical or other means.
• Adequate tumour tissue (greater than 0.5cm3 preferred, 3 X core biopsy acceptable) available and agreement from subjects that this tissue from their primary and/or metastatic tumour be made available for assessment of potential biomarkers.
• Ability and availability to complete all prescribed biomarker studies (Screening and after Cycle 2).
• Recovered to Grade 1 from reversible toxicities of prior therapy
• Presence of clinically and/or radiologically documented disease. At least one site of disease (which will not be removed during the course of the study) must be uni-dimensionally measurable as per RECIST 1.1 or clinically quantifiable (such as in the case of skin disease)
• ECOG performance status of 0 - 1.
• Prior treatment with any number of immunotherapies (e.g., IL2, ipilimumab), targeted therapies (e.g., vemurafenib) are permitted but no more than one 1 prior chemotherapy
• Acceptable liver function
• Acceptable renal function
• Acceptable hematologic status (without growth factor support for neutropenia or transfusion dependency):
• Normal 12-lead ECG (clinically insignificant abnormalities permitted)
• Female subjects of childbearing age must have a negative urine HCG test unless prior hysterectomy or menopause (defined as age above 55 and twelve months without menstrual activity). Female subjects should not become pregnant or breast-feed while on this study. Sexually active male and female subjects should use effective birth control.

You may not qualify if:

• Anticancer treatment with radiation therapy, targeted therapies, chemotherapy, immunotherapy, hormones or other antitumour therapies within 28 days prior to first dose of TH-302.
• Subjects who have received any other investigational drug or agent within 28 days of first dose of TH-302
• Current use of drugs with known cardiotoxicity
• Significant cardiac dysfunction:
• Seizure disorders requiring anticonvulsant therapy
• Progressing brain metastases (unless previously treated and stable disease for a period of greater than or equal to 3 months on repeat MRI following definitive treatment).
• History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 2 years
• Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation less than 90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause hypoxia of normal tissue.
• Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Prior therapy with an hypoxic cytotoxin
• Known infection with HIV or active infection with hepatitis B or hepatitis C
• History of allergic reaction to a structural compound or biological agent similar to TH-302
• Pregnancy or breast-feeding
• Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study

Sponsors & Collaborators

• ImmunoGenesis: lead

Study Sites (7)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

UCLA

Los Angeles, California, 90404, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G1Z2, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V5C2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G2M9, Canada

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis

Interventions

TH 302

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Thomas Wilson
• Organization: Threshold Pharmaceuticals

twilso2112@gmail.com

302-359-0565

Study Officials

• Tillman Pearce, MD

  Threshold Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 29, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 11, 2025
• Results First Posted: August 16, 2017

Record last verified: 2025-05

Locations

US (3); CA (4)