NCT04293094 : A Phase 1, Multicenter, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumors

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18-99Age 18-99

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Breast,Female reproductive organsBreast,Endometrium,Fallopian tube,Ovary

Trial Overview Read MoreRead more

This phase I trial is trying to find a safe and tolerable dose of a new oral drug to treat patients diagnosed with advanced cancer, in particular patients with triple negative breast cancer, ovarian cancer and endometrial cancer.
 

This trial is treating patients with triple negative breast cancer, ovarian cancer or endometrial cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase 1, Multicenter, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumors

Commercial Sponsor

AMGEN

Summary

This is a dose exploration and expansion trial. In the dose exploration phase, eligible patients will receive or AMG 650 to understand the maximum tolerated and recommended phase 2 dose (RP2D), which will be estimated using isotonic regression. In the dose expansion phase of the trial, eligible patients will be assigned, according to their cancer diagnosis, to receive the preliminary RP2D of oral AMG 650 identified in the dose exploration phase of the trial.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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