Study of Intravenous RXDX-107 in Patients With Solid Tumors

Phase 1

Terminated

• Conditions: Solid Tumor
• Interventions: Drug: RXDX-107

• Registration Number: NCT02548390
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This is an open-label, Phase I/Ib, dose escalation study of intravenous RXDX-107 administered to subjects with advanced solid tumors. The study is designed to explore the safety, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RXDX-107 and to define a recommended Phase 2 dose (RP2D)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Confirmed relapsed or refractory locally advanced or metastatic solid cancer for whom no standard therapy is considered appropriate, or for whom standard therapy is considered intolerable.

2. >18 years of age.

3. ECOG performance status of 0 or 1.

4. Life expectancy of at least 3 months.

5. Received the last dose of previous treatment / therapy before Day 1 of cycle 1:

   • 28 days for cytotoxic chemotherapy, immunotherapy, whole brain radiotherapy, anticonvulsive therapy, stereotactic radiosurgery and major surgery
   • 42 days for nitrosureas, mitomycin C, and liposomal anthracycline
   • 14 days for non-cytotoxic cancer therapies and radiotherapy

6. Recovered from all toxic effects (excluding alopecia) of any prior anti-cancer therapy to Grade ≤ 1 or to the baseline laboratory values.

7. Adequate organ function and baseline laboratory values

8. Women of childbearing potential must have a negative serum pregnancy

Phase 1b: Patient must have measurable disease

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Exclusion Criteria

1. Receiving other experimental therapy
2. Known symptomatic brain mets or leptomeningeal involvement
3. Myocardial infarction in the previous 12 weeks. Active ischemia or any other uncontrolled cardiac condition such as angina pectoris, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or CHF.
4. Another concurrent illness which would preclude study conduct and assessment, uncontrolled: medical condition, active infection, risk of bleeding, diabetes mellitus, or pulmonary disease, or alcoholic liver disease, or primary biliary cirrhosis.
5. Malignancy within 3 years or active disease requiring treatment other than the target cancer. The exceptions are prostate cancer (Gleason grade < 6 with normalized PSA levels), treated in situ cervical, breast carcinoma, squamous or basal cell skin cancer.
6. Any condition that may compromise the ability to give written informed consent or to comply with the study protocol.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RXDX-107	RXDX-107	-

Primary Outcome Measures

Name	Time	Method
Phase 1: Plasma clearance (CL)	Approx. 1 year	Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Phase 1: Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)	Approx. 6 months
Phase 1: Safety profile of RXDX-107 as characterized by Adverse Events, ECG and laboratory abnormalities	Approx. 1 year	AEs, ECG and Labs assessed according to NCI CTCAE V4.0
Phase 1b: Confirm RP2D	Approx. 1 year	Number of participants with Treatment-related AEs, Labs changes from baseline, and QTc interval changes from baseline assessed according to NCI CTCAE V4.0, concomitant medication usage, including all supportive care provided, and preliminary anti-tumor activity per RECIST v1.1 as assessed by Investigator
Phase 1: Maximum observed plasma drug concentration (Cmax)	Approx. 1 year	Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Phase 1: Time to Cmax, by inspection (tmax)	Approx. 1 year	Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Phase 1: Apparent plasma terminal elimination rate constant (λz) and associated terminal half life (t½)	Approx. 1 year	Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)
Phase 1: Area under the drug concentration by time curve (AUC)	Approx. 1 year	From time 0 to the time of the last detectable plasma concentration (AUC0-t)
Phase 1: Volume of distribution (Vz)	Approx. 1 year	Plasma concentrations obtained following the dose on Day 1 (and from the dose on Day 2 in patients receiving the Day 1 and Day 2 schedule)

Secondary Outcome Measures

Name	Time	Method
Antitumor activity of RXDX-107 as measured by Objective Response Rate (ORR)	Approx. 1 year	Per RECIST v1.1 as assessed by Investigator

Trial Locations

Locations (3)

Florida Cancer Specialists; 🇺🇸 Sarasota, Florida, United States

Johns Hopkins Medical Institute; 🇺🇸 Baltimore, Maryland, United States

Tennessee Oncology, LLC; 🇺🇸 Nashville, Tennessee, United States