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

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

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