Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Breast Neoplasms

Pancreatic Neoplasms

Prostatic Neoplasms

Stomach Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Pancreatic Cancer

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Reproductive Control Agents

Paclitaxel

Albumin-Bound Paclitaxel

Pancrelipase

Pancreatin

Triptolide

Minnelide™ Capsules will be given as a single agent orally once daily x 21 days followed by a 7-day off schedule. One cycle will equal 28 days. MinnelideTM Capsules should be given with the patient in a fasting state.

MinnelideTM Capsules will be given orally once daily x 21 days in combination with protein-bound paclitaxel given intravenously on days 1, 8 and 15 in patients with pancreas and breast cancer. One cycle will equal 28 days. MinnelideTM Capsules should be given with the patient in a fasting state.

Minnelide™ Capsules will be given as a single agent orally once daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days. Minnelide™ Capsules should be given with the patient in a fasting state.

Minnelide™ is a water soluble disodium salt variant of triptolide an heat shock protein (HSP) inhibitor.

Minnelide™Capsules

Jordan Jacobs, MBA

Mohana Velagapudi, MD

Ravi K Paluri, MD

Joyce Schaffer, MSN,RN,AOCNS

Erkut Borazanci, MD, MS

Jaime Richardson, RN

Monica Mita, MD

Austin Humbert

A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Minnelide™Capsules given daily for 21 days followed by 7 days off schedule in patients with Advanced Solid Tumors

A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors

Translational Drug Development

Minneamrita Therapeutics LLC

Blood and Lymph Conditions

Immune System Diseases

Carcinoma, Squamous Cell

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Carcinoma, Basal Cell

Sarcoma

Lymphoma, T-Cell, Cutaneous

Squamous Cell Carcinoma of Head and Neck

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Breast Diseases

Skin Diseases

Neoplasms, Squamous Cell

Lymphoma, Non-Hodgkin

Head and Neck Neoplasms

Neoplasms, Basal Cell

Lymphosarcoma

Peripheral T-cell Lymphoma

Soft Tissue Sarcoma

Cutaneous T-cell Lymphoma

Capecitabine

Hormones

Antimetabolites

GZ17-6.02 given orally on a daily x 28 day schedule. This will be a dose escalation study.

GZ17-6.02 given orally twice daily x 21 day schedule in combination with Capecitabine 825 mg/m2 orally twice daily for 14 days x 21 day schedule.

GZ17-6.02 given orally twice daily x 21 day schedule in combination with Capecitabine 850 mg/m2 orally twice daily for 14 days x 21 day schedule.

GZ17-6.02

Kathryn Gazarik

This Phase I/Ib study is a Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination with Capecitabine, Given Orally on a Daily Schedule in Patients with Advanced Solid Tumors or Lymphoma

This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a novel anti-cancer drug, GZ17-6.02 administered to patients with advanced solid tumors or lymphoma, which have progressed after receiving standard/approved therapy or where there is no approved therapy.

This study will determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of GZ17-6.02 monotherapy and in combination with standard-of-care oncology treatments and to establish the dose of GZ17-6.02 recommended for future monotherapy and combination therapies phase II oncology clinical studies.

Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer

A Phase I/Ib, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination With Capecitabine, Given Orally on a Daily Schedule in Patients With Advanced Solid Tumors or Lymphoma

Genzada Pharmaceuticals USA, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors	NCT03129139	Advanced Cancer Gastric Cancer Breast Cancer Pancreatic Canc... Prostate Cancer... Colo-rectal Can... Solid Tumor Solid Carcinoma Solid Carcinoma... Cancer of Stoma...	Minnelide™Capsu...	18 Years -	Minneamrita Therapeutics LLC
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors	NCT03129139	Advanced Cancer Gastric Cancer Breast Cancer Pancreatic Canc... Prostate Cancer... Colo-rectal Can... Solid Tumor Solid Carcinoma Solid Carcinoma... Cancer of Stoma...	Minnelide™Capsu...	18 Years -	Minneamrita Therapeutics LLC
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors	NCT03129139	Advanced Cancer Gastric Cancer Breast Cancer Pancreatic Canc... Prostate Cancer... Colo-rectal Can... Solid Tumor Solid Carcinoma Solid Carcinoma... Cancer of Stoma...	Minnelide™Capsu...	18 Years -	Minneamrita Therapeutics LLC
Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer	NCT03775525	Advanced Cancer Gastric Cancer Breast Cancer Pancreatic Canc... Prostate Cancer... Colo-rectal Can... Solid Tumor Solid Carcinoma Solid Carcinoma... Cancer of Stoma... Lymphoma Sarcoma Cutaneous T Cel... Head and Neck S... Basal Cell Carc... Cutaneous T-cel... Cutaneous Squam...	GZ17-6.02 Capecitabine	18 Years -	Genzada Pharmaceuticals USA, Inc.

Spots Global Cancer Trial Database for solid carcinoma of stomach